Multifocal Motor NeuropathyPhase 3NCT00666263

Study of the Effectiveness of Intravenous Immune Globulin (10%) for the Treatment of Multifocal Motor Neuropathy

A Phase 3 study testing Immune Globulin Intravenous (human), 10% in people with Multifocal Motor Neuropathy, run by Baxalta now part of Shire at 17 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study is to evaluate the efficacy (effect on grip strength and disability) and safety/tolerability of IGIV, 10% in subjects with Multifocal Motor Neuropathy. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Multifocal Motor Neuropathy
What is being tested?: Immune Globulin Intravenous (human), 10%
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 50 participants
Where: 17 sitesin 3 countries
Study dates: 22 Aug 2008to 11 Aug 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Written informed consent obtained from the participant prior to any study-related procedures and study product administration
Diagnosis of definite or probable MMN based on the criteria of the American Association of Electrodiagnostic Medicine (AAEM) (Olney et al., 2003, see Section 15.1 for the full length publication). Conduction block can be identified by a drop in amplitude. Diagnosis can be based on chart records a) Hand grip (finger flexor) weakness of Medical Research Council (MRC) grade 4 or less at disease onset or appearing prior to screening; b) No upper motor signs c) No bulbar or cranial signs or symptoms; d) No clinically identifiable sensory abnormalities
Must be on a stable regimen of IGIV for at least 3 months prior to first study product administration
Treatment interval with IGIV of 2 to 5 weeks (+/- 3 days)
Dose of IGIV to be 0.4 to 2.0 g per kg BW and infusion cycle
Participants are adults, male or female, at least 18 years of age
If female and capable of bearing children - have a negative urine pregnancy test result at enrollment and agree to employ adequate birth control measures for the duration of the study
Ability and willingness to travel to the study site for infusions and assessments if required by the protocol

Who cannot join

Any clinical or electrophysiological evidence of coexisting neuropathy which may interfere with outcome assessments, such as diabetic neuropathy, toxic neuropathy, or neuropathy due to systemic lupus erythematosus
Treatment with other immunosuppressive agents besides IGIV, which has demonstrated efficacy in MMN such as cyclophosphamide during the 3 months prior to enrollment (or treatment with Rituximab during the 12 months prior to enrollment). Pre-study treatment with mycophenolate mofetil or azathioprine is permitted if the dose has been stable for 3 months prior to enrollment.
Cerebrospinal fluid protein > 100 mg/dL (if done as part of a previous evaluation)
Participants positive at enrollment for one or more of the following: Hepatitis B surface antigen (HBsAg), polymerase chain reaction (PCR) for Hepatitis C (HCV), PCR for human immunodeficiency virus (HIV) Type 1
Participants with levels of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 times the upper limit of normal for the testing laboratory
Participants with neutropenia (defined as an absolute neutrophil count [ANC]≤1000/mm^3)

Show all 15Show fewer

Participants with serum creatinine levels greater than 1.5 times the upper limit of normal for age and gender
Participants with malignancy other than adequately treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
Participants with a history of thrombotic episodes (deep vein thrombosis, myocardial infarction, cerebrovascular accident)
Participants who received any blood or blood product exposure other than an IGIV, subcutaneous immunoglobulin, immune serum globulin (ISG) preparation, or albumin within the 6 months prior to enrollment
Participants with an ongoing history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following IGIV or human albumin
Participants with immunoglobulin A (IgA) deficiency and known anti IgA antibodies
Participants using another investigational product or device within 30 days prior to enrollment
Participants who are unable or unwilling to meet all the requirements of this study
If female, is pregnant or lactating at time of enrollment

Trial locations and contacts

17 sites in 3 countries.

Country

City, postcode or hospital

17 sites in 3 countries

United States12 sites

Study site
Baltimore, Maryland
Study site
Boston, Massachusetts
Study site
Centennial, Colorado
Study site
Columbus, Ohio
Study site
Houston, Texas
Study site
Kansas City, Kansas
Study site
Los Angeles, California
Study site
Miami, Florida
Study site
Portland, Oregon
Study site
Seattle, Washington
Study site
St Louis, Missouri
Study site
Stanford, California

Other trials in United States

Canada4 sites

Study site
Calgary, Alberta
Study site
Kingston, Ontario
Study site
London, Ontario
Study site
Montreal, Quebec

Other trials in Canada

Denmark1 site

Study site
Aarhus

Other trials in Denmark

About this study

Official title: A Randomized, Double-Blind, Placebo Controlled, Cross-over Study of the Effectiveness of Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for the Treatment of Multifocal Motor Neuropathy

The purpose of the study is to evaluate the efficacy (effect on grip strength and disability) and safety/tolerability of IGIV, 10% in subjects with Multifocal Motor Neuropathy.

Conditions: Multifocal Motor Neuropathy
Being tested: Immune Globulin Intravenous (human), 10%, 0.25% human albumin solution (Placebo)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Immune Globulin Intravenous (human), 10%Biological
Also called IGIV, 10%, GAMMAGARD LIQUID, KIOVIG
Dose: Previous dose with 3, 4, or 6 cycles depending on previous schedule (patient specific)
0.25% human albumin solution (Placebo)Biological
Also called BUMINATE 25%, Albumin (Human) Solution, Human Albumin 200 g/L Baxter
Cross-over Period 1 (Randomized) / Cross-over Period 2 (opposite of the treatment received in Cross-over Period 1); Dose: Same volume/frequency as Stabilization Phase 1

Study groups in NCT00666263
Study group	Role	What they receive
IGIV, 10% Then Placebo	Experimental	STUDY PART 1: Open-label stabilization on IGIV, 10% (Stabilization Phase 1) all participants. STUDY PART 2: IGIV, 10% (double-blind treatment Cross-Over Period 1). STUDY PART 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 2). STUDY PART 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over period 2). STUDY PART 5: Participants received open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 3). Each study part was 12 weeks in length. Participants received IGIV, 10% at the same equivalent dose per week administered prior to the study (0.4 to 2.0 g per kg body weight (BW) per infusion cycle). Receives: Biological: Immune Globulin Intravenous (human), 10%; Biological: 0.25% human albumin solution (Placebo)
Placebo Then IGIV, 10%	Experimental	STUDY PART 1: Open-label stabilization on IGIV, 10% (Stabilization Phase 1) all participants. STUDY PART 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human) (Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment Cross-Over Period 1). STUDY PART 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 2). STUDY PART 4: IGIV, 10% (double-blind treatment cross-over period 2). STUDY PART 5: Participants received open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 3). Each study part was 12 weeks in length. Participants received IGIV, 10% at the same equivalent dose per week administered prior to the study (0.4 to 2.0 g per kg BW per infusion cycle) Receives: Biological: Immune Globulin Intravenous (human), 10%; Biological: 0.25% human albumin solution (Placebo)

What is being measured

The primary outcome is the main question the study is designed to answer.

Grip Strength in the More Affected Hand
The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg. Each grip strength test consisted of 3 maximal repeated contractions (trials). Each participant will perform 2 sessions of grip strength testing. After a 10-minute break, the testing session will be repeated for a total of 6 grip repetitions per hand.
Measured: Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit
Mean Relative Change in Grip Strength in the More Affected Hand
Relative Change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period. The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg. For statistical analysis, the mean of (usually three) trials for cross-over sessions 1 and 2 was computed and the mean of the sessions was used in the analysis as the result of the grip strength measurement. Only if no grip strength testing could be performed the results were considered as missing.
Measured: Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)
Co-Primary Endpoint: Guy's Neurologic Disability Scale (GNDS) for Upper Limbs
GNDS (based on Sharrack and Hughes, 1999) for the upper limbs were integers 0 to 5, with 0 indicating no impairment.
Measured: Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit
Co-Primary Endpoint: Proportion of Participants With Deterioration in Guy's Neurological Disability Score (GNDS)
GNDS (based on Sharrack and Hughes, 1999) for the upper limbs were integers 0 to 5, with 0 indicating no impairment.
Measured: Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)
Rate of Temporally Associated Adverse Events (AEs) Per Infusion
The total number of all AEs which begin during or within 72 hours of completion of an infusion, irrespective of being related or not related to the study product (IGIV, 10% or Placebo), divided by the total number of infusions, and multiplied by 100.
Measured: Within 72 hours of completion of an infusion during the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)
The Percentage of Participants for Whom the Infusion Rate of Any Infusion Was Reduced and/or the Infusion Was Interrupted or Stopped for Any Reason
Measured: Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)
The Percentage of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped for Any Reason
Measured: Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)
The Percentage of Participants Reporting One or More Moderate or Severe AEs That Began During Infusion or Within 72 Hours of Completion of an Infusion
Measured: Within 72 hours of completion of an infusion during the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)

Secondary outcomes (19)

Percentage of Participants With at Least a 30% Decline in Relative Grip Strength in the More Affected Hand (Measured Using a DynEx Digital Dynamometer)
Relative grip strength change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period. The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg. For statistical analysis, the mean of (usually three) trials for cross-over sessions 1 and 2 was computed and the mean of the sessions was used in the analysis as the result of the grip strength measurement. Only if no grip strength testing could be performed the results were considered as missing.
Measured: Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)
Grip Strength in the Less Affected Hand
The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg. Each grip strength test consisted of 3 maximal repeated contractions (trials). Each participant will perform 2 sessions of grip strength testing. After a 10-minute break, the testing session will be repeated for a total of 6 grip repetitions per hand.
Measured: Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit
Mean Relative Change in Grip Strength in the Less Affected Hand
Relative Change is defined as 100 * (End of the Cross-Over Period - Baseline of Cross-Over Period) divided by baseline of Cross-Over Period. The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg. For statistical analysis, the mean of (usually three) trials for cross-over sessions 1 and 2 was computed and the mean of the sessions was used in the analysis as the result of the grip strength measurement. Only if no grip strength testing could be performed the results were considered as missing.
Measured: Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)
Proportion of Participants That Were Accelerated Forward Into the Next Stabilization Phase (ie Switched to Open-Label IGIV, 10%)
Participants were permitted to switch from blinded treatment with placebo or IGIV, 10% to open label IGIV, 10% if they and investigator agreed that deterioration had occurred to the extent that the participant had unacceptable difficulty carrying out daily activities involving the affected muscles, or decline in grip strength of ≥50% in the more affected hand had occurred.
Measured: During the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)
Patient Global Impression of Change
Patient Global Impression of Change was measured on an ordinal scale of 1-7, higher scores representing greater perceived deterioration since the previous efficacy assessment (ranging from (1) very much improved to very much worse (7)). 1. Very much improved 2. Much improved 3. Minimally improved 4. No change 5. Minimally worse 6. Much worse 7. Very much worse
Measured: Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit
Overall Disability Sum Score
The overall disability sum scale (based on Merkies et al., 2002) is a patient questionnaire that measures disability. Overall disability sum score = arm disability scale (range 0-5) + leg disability scale (range 0-7); Overall Range: 0 (no signs of disability) to 12 (maximum disability).
Measured: Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit
Overall Disability Sum Score - Standardized
The overall disability sum scale (based on Merkies et al., 2002) is a patient questionnaire that measures disability. Overall disability sum score = arm disability scale (range 0-5) + leg disability scale (range 0-7); Overall Range: 0 (no signs of disability) to 12 (maximum disability). This was standardized to a scale of 0 to 100 (the best score being 100) to allow calculation of relative changes.
Measured: Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit
Mean Relative Change in Overall Disability Sum Score
Relative Change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period. The overall disability sum scale (based on Merkies et al., 2002) is a patient questionnaire that measures disability (from 0, "no signs of disability" to 12, "most severe disability"). This was standardized to a scale of 0 to 100 (the best score being 100) to allow calculation of relative changes.
Measured: Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)
Time Required by Participants to Complete the 9 Hole Peg Board Test (9-HPT) With the Dominant Hand
The 9-HPT is a quantitative measure of upper extremity (arm and hand) function. Participants picked up the pegs one at a time (nine in total), and put them into the holes on the board as quickly as possible, in any order until all the holes were filled. Then, without pausing, participants removed the pegs one at a time and returned them to the container as quickly as possible. Each participant did this two times with their dominant hand. The 9-HCT objective is to see how fast participants could put all of the pegs in and take them out again.
Measured: Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit
Mean Relative Change in Time Required by Participants to Complete the 9 Hole Peg Board Test (9-HPT) With the Dominant Hand
Relative Change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period. The 9-HPT is a quantitative measure of upper extremity (arm and hand) function. Participants picked up the pegs one at a time (nine in total), and put them into the holes on the board as quickly as possible, in any order until all the holes were filled. Then, without pausing, participants removed the pegs one at a time and returned them to the container as quickly as possible. Each participant did this two times with their dominant hand. The 9-HCT objective is to see how fast participants could put all of the pegs in and take them out again.
Measured: Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)
Time Required by Participants to Complete the 9 Hole Peg Board Test (9-HPT) With the Non-Dominant Hand
The 9-HPT is a quantitative measure of upper extremity (arm and hand) function. Participants picked up the pegs one at a time (nine in total), and put them into the holes on the board as quickly as possible, in any order until all the holes were filled. Then, without pausing, participants removed the pegs one at a time and returned them to the container as quickly as possible. Each participant did this two times with their non-dominant hand. The 9-HCT objective is to see how fast participants could put all of the pegs in and take them out again.
Measured: Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit
Mean Relative Change in Time Required by Participants to Complete the 9 Hole Peg Board Test (9-HPT) With the Non-Dominant Hand
Relative Change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period. The 9-HPT is a quantitative measure of upper extremity (arm and hand) function. Participants picked up the pegs one at a time (nine in total), and put them into the holes on the board as quickly as possible, in any order until all the holes were filled. Then, without pausing, participants removed the pegs one at a time and returned them to the container as quickly as possible. Each participant did this two times with their non-dominant hand. The 9-HCT objective is to see how fast participants could put all of the pegs in and take them out again.
Measured: Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)
Participants' Assessment of Physical Functioning on a Visual Analog Scale (VAS)
The VAS measured patients' assessment of physical functioning on a 10 centimeter scale of 0-10, on which 0 represents "no symptoms" and 10 "disabled, unable to use affected limbs".
Measured: Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit
Mean Relative Change in Participants' Assessment of Physical Functioning on a Visual Analog Scale (VAS)
Relative Change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period. The VAS measured patients' assessment of physical functioning on a 10 centimeter scale of 0-10, on which 0 represents "no symptoms" and 10 "disabled, unable to use affected limbs".
Measured: Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)
Rate of Related AEs Per Infusion
The total number of AEs determined by the investigator to be related to the study product that occur at any time during the study divided by the total number of infusions, and multiplied by 100.
Measured: Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)
Rate of Related SAEs Per Infusion
The total number of SAEs determined by the investigator to be related to the study product that occur at any time during the study divided by the total number of infusions, and multiplied by 100.
Measured: Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)
The Proportion of Participants for Whom the Infusion Rate of Any Infusion Was Reduced and/or the Infusion Was Interrupted or Stopped for Tolerability Concerns/AEs
Measured: Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)
The Proportion of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped for Tolerability Concerns/AEs
Measured: Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)
The Proportion of Infusions Associated With One or More AEs Related to the Study Product
Measured: Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Aug 200811 Aug 2011

First posted24 Apr 2008 (estimated)
Study start22 Aug 2008
Primary completion11 Aug 2011
Study completion11 Aug 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Multifocal Motor NeuropathyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00666263
Sponsor's protocol ID: 160604
Other IDs: 2009-013841-27, 2009
Status last verified: Apr 2021
First submitted: 23 Apr 2008
Last updated: 19 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Merkies IS, Schmitz PI, van der Meche FG, Samijn JP, van Doorn PA; Inflammatory Neuropathy Cause and Treatment (INCAT) group. Clinimetric evaluation of a new overall disability scale in immune mediated polyneuropathies. J Neurol Neurosurg Psychiatry. 2002 May;72(5):596-601. doi: 10.1136/jnnp.72.5.596.
PubMed 11971045
Sharrack B, Hughes RA. The Guy's Neurological Disability Scale (GNDS): a new disability measure for multiple sclerosis. Mult Scler. 1999 Aug;5(4):223-33. doi: 10.1177/135245859900500406.
PubMed 10467380
Koski CL, Schiff RI, Oh M, Lee D. Characteristics of patients with multifocal motor neuropathy enrolled in a randomized controlled trial of intravenous gammaglobulin. Poster. 63rd Annual Meeting of American Academy of Neurology (AAN), April 9-16, 2011, Honolulu, HI, USA.
Li Z, Roepcke S, Franke R, Yel L. Dose-exposure-efficacy response of intravenous immunoglobulin G 10% in multifocal motor neuropathy. Ann Clin Transl Neurol. 2024 Aug;11(8):1977-1987. doi: 10.1002/acn3.52098. Epub 2024 Jul 8.
PubMed 38978354

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study to Assess the Effect of Empasiprubart on Nerve Morphology by Ultrasound in Adults With Multifocal Motor Neuropathy
Multifocal Motor Neuropathy (MMN)
Active, not recruitingPhase 3
A Study to Assess the Efficacy and Safety of Empasiprubart Versus IVIg in Adults With Multifocal Motor Neuropathy
Multifocal Motor Neuropathy (MMN), MMN
Active, not recruitingObservational study
Polyneuropathy, Impairments and Physical Activity - The PolyImPAct Study
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All Multifocal Motor Neuropathy trials

Study at a glance

From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo Controlled, Cross-over Study of the Effectiveness of Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for the Treatment of Multifocal Motor Neuropathy
ClinicalTrials.gov ID: NCT00666263
Acronym / sponsor ID: 160604
Conditions: Multifocal Motor Neuropathy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Baxalta now part of ShireIndustry (pharma, biotech, devices)
Study start: 22 Aug 2008 (actual)
Primary completion: 11 Aug 2011 (actual)
Study completion: 11 Aug 2011 (actual)
First posted: 24 Apr 2008 (estimated)
Results: Posted 13 Mar 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of the study is to evaluate the efficacy (effect on grip strength and disability) and safety/tolerability of IGIV, 10% in subjects with Multifocal Motor Neuropathy.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
IGIV, 10% Then Placebo	Experimental	Biological: Immune Globulin Intravenous (human), 10%, Biological: 0.25% human albumin solution (Placebo)STUDY PART 1: Open-label stabilization on IGIV, 10% (Stabilization Phase 1) all participants. STUDY PART 2: IGIV, 10% (double-blind treatment Cross-Over Period 1). STUDY PART 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 2). STUDY PART 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over period 2). STUDY PART 5: Participants received open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 3). Each study part was 12 weeks in length. Participants received IGIV, 10% at the same equivalent dose per week administered prior to the study (0.4 to 2.0 g per kg body weight (BW) per infusion cycle).
Placebo Then IGIV, 10%	Experimental	Biological: Immune Globulin Intravenous (human), 10%, Biological: 0.25% human albumin solution (Placebo)STUDY PART 1: Open-label stabilization on IGIV, 10% (Stabilization Phase 1) all participants. STUDY PART 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human) (Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment Cross-Over Period 1). STUDY PART 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 2). STUDY PART 4: IGIV, 10% (double-blind treatment cross-over period 2). STUDY PART 5: Participants received open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 3). Each study part was 12 weeks in length. Participants received IGIV, 10% at the same equivalent dose per week administered prior to the study (0.4 to 2.0 g per kg BW per infusion cycle)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Written informed consent obtained from the participant prior to any study-related procedures and study product administration
Diagnosis of definite or probable MMN based on the criteria of the American Association of Electrodiagnostic Medicine (AAEM) (Olney et al., 2003, see Section 15.1 for the full length publication). Conduction block can be identified by a drop in amplitude. Diagnosis can be based on chart records a) Hand grip (finger flexor) weakness of Medical Research Council (MRC) grade 4 or less at disease onset or appearing prior to screening; b) No upper motor signs c) No bulbar or cranial signs or symptoms; d) No clinically identifiable sensory abnormalities
Must be on a stable regimen of IGIV for at least 3 months prior to first study product administration
Treatment interval with IGIV of 2 to 5 weeks (+/- 3 days)
Dose of IGIV to be 0.4 to 2.0 g per kg BW and infusion cycle

Key exclusion criteria (15 listed)

Any clinical or electrophysiological evidence of coexisting neuropathy which may interfere with outcome assessments, such as diabetic neuropathy, toxic neuropathy, or neuropathy due to systemic lupus erythematosus
Treatment with other immunosuppressive agents besides IGIV, which has demonstrated efficacy in MMN such as cyclophosphamide during the 3 months prior to enrollment (or treatment with Rituximab during the 12 months prior to enrollment). Pre-study treatment with mycophenolate mofetil or azathioprine is permitted if the dose has been stable for 3 months prior to enrollment.
Cerebrospinal fluid protein > 100 mg/dL (if done as part of a previous evaluation)
Participants positive at enrollment for one or more of the following: Hepatitis B surface antigen (HBsAg), polymerase chain reaction (PCR) for Hepatitis C (HCV), PCR for human immunodeficiency virus (HIV) Type 1
Participants with levels of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 times the upper limit of normal for the testing laboratory

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Immune Globulin Intravenous (human), 10%Also: IGIV, 10%, GAMMAGARD LIQUID, KIOVIGDose: Previous dose with 3, 4, or 6 cycles depending on previous schedule (patient specific)	Biological	IGIV, 10% Then Placebo, Placebo Then IGIV, 10%
0.25% human albumin solution (Placebo)Also: BUMINATE 25%, Albumin (Human) Solution, Human Albumin 200 g/L BaxterCross-over Period 1 (Randomized) / Cross-over Period 2 (opposite of the treatment received in Cross-over Period 1); Dose: Same volume/frequency as Stabilization Phase 1	Biological	IGIV, 10% Then Placebo, Placebo Then IGIV, 10%

Primary outcome

Grip Strength in the More Affected Hand
Time frame: Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit
The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg. Each grip strength test consisted of 3 maximal repeated contractions (trials). Each participant will perform 2 sessions of grip strength testing. After a 10-minute break, the testing session will be repeated for a total of 6 grip repetitions per hand.
Mean Relative Change in Grip Strength in the More Affected Hand
Time frame: Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)
Relative Change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period. The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg. For statistical analysis, the mean of (usually three) trials for cross-over sessions 1 and 2 was computed and the mean of the sessions was used in the analysis as the result of the grip strength measurement. Only if no grip strength testing could be performed the results were considered as missing.
Co-Primary Endpoint: Guy's Neurologic Disability Scale (GNDS) for Upper Limbs
Time frame: Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit
GNDS (based on Sharrack and Hughes, 1999) for the upper limbs were integers 0 to 5, with 0 indicating no impairment.
Co-Primary Endpoint: Proportion of Participants With Deterioration in Guy's Neurological Disability Score (GNDS)
Time frame: Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)
GNDS (based on Sharrack and Hughes, 1999) for the upper limbs were integers 0 to 5, with 0 indicating no impairment.
Rate of Temporally Associated Adverse Events (AEs) Per Infusion
Time frame: Within 72 hours of completion of an infusion during the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)
The total number of all AEs which begin during or within 72 hours of completion of an infusion, irrespective of being related or not related to the study product (IGIV, 10% or Placebo), divided by the total number of infusions, and multiplied by 100.
The Percentage of Participants for Whom the Infusion Rate of Any Infusion Was Reduced and/or the Infusion Was Interrupted or Stopped for Any Reason
Time frame: Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)
The Percentage of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped for Any Reason
Time frame: Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)
The Percentage of Participants Reporting One or More Moderate or Severe AEs That Began During Infusion or Within 72 Hours of Completion of an Infusion
Time frame: Within 72 hours of completion of an infusion during the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)

19 secondary outcomes

Percentage of Participants With at Least a 30% Decline in Relative Grip Strength in the More Affected Hand (Measured Using a DynEx Digital Dynamometer)
Time frame: Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)
Grip Strength in the Less Affected Hand
Time frame: Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit
Mean Relative Change in Grip Strength in the Less Affected Hand
Time frame: Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)
Proportion of Participants That Were Accelerated Forward Into the Next Stabilization Phase (ie Switched to Open-Label IGIV, 10%)
Time frame: During the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)
Patient Global Impression of Change
Time frame: Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit
Overall Disability Sum Score
Time frame: Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit
Overall Disability Sum Score - Standardized
Time frame: Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit
Mean Relative Change in Overall Disability Sum Score
Time frame: Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)
Time Required by Participants to Complete the 9 Hole Peg Board Test (9-HPT) With the Dominant Hand
Time frame: Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit
Mean Relative Change in Time Required by Participants to Complete the 9 Hole Peg Board Test (9-HPT) With the Dominant Hand
Time frame: Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)
Time Required by Participants to Complete the 9 Hole Peg Board Test (9-HPT) With the Non-Dominant Hand
Time frame: Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit
Mean Relative Change in Time Required by Participants to Complete the 9 Hole Peg Board Test (9-HPT) With the Non-Dominant Hand
Time frame: Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)
Participants' Assessment of Physical Functioning on a Visual Analog Scale (VAS)
Time frame: Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit
Mean Relative Change in Participants' Assessment of Physical Functioning on a Visual Analog Scale (VAS)
Time frame: Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)
Rate of Related AEs Per Infusion
Time frame: Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)
Rate of Related SAEs Per Infusion
Time frame: Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)
The Proportion of Participants for Whom the Infusion Rate of Any Infusion Was Reduced and/or the Infusion Was Interrupted or Stopped for Tolerability Concerns/AEs
Time frame: Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)
The Proportion of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped for Tolerability Concerns/AEs
Time frame: Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)
The Proportion of Infusions Associated With One or More AEs Related to the Study Product
Time frame: Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)

Results and safety

Results posted to the registry on 13 Mar 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IGIV, 10% Then Placebo (During Cross-Over Periods)	22	22
Placebo Then IGIV, 10% (During Cross-Over Periods)	22	21

Primary outcome: Grip Strength in the More Affected Hand

Time frame: Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit. Median (Inter-Quartile Range). Unit: kilograms

Measure	Before Stabilization 1 n = 44	End of Stabilization 1 n = 44	End of Cross-Over 1 n = 42	End of Stabilization 2 n = 43	End of Cross-Over 2 n = 43	End of Stabilization 3 n = 36	End of the Study n = 43
IGIV then Placebo (N= 22, 22, 22, 22, 22, 17, 21)	18.14 (9.30 to 30.43)	21.68 (14.05 to 30.83)	19.54 (10.15 to 29.15)	19.39 (12.75 to 33.25)	11.28 (5.50 to 25.92)	17.77 (9.23 to 27.07)	17.37 (10.80 to 29.03)
Placebo then IGIV (N= 22, 22, 20, 21, 21, 19, 22)	13.17 (5.30 to 20.08)	14.17 (8.08 to 27.47)	8.38 (4.86 to 17.03)	14.18 (7.60 to 27.35)	15.98 (10.73 to 29.65)	14.28 (9.47 to 28.25)	14.00 (7.48 to 24.82)

Population analysed: Intent to treat

Primary outcome: Mean Relative Change in Grip Strength in the More Affected Hand

Time frame: Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4). Mean (95% Confidence Interval). Unit: Percent change in grip strength

Measure	Arm 1: IGIV, 10% Then Placebo- Crossover Period 1 n = 22	Arm 1: IGIV, 10% Then Placebo- Crossover Period 2 n = 22	Arm 2: Placebo Then IGIV, 10% - Crossover Period 1 n = 20	Arm 2: Placebo Then IGIV, 10% - Crossover Period 2 n = 21
Value	-16.36 (-30.92 to -1.80)	-30.52 (-43.68 to -17.36)	-30.11 (-48.41 to -11.81)	23.86 (-23.11 to 70.83)

Arm 1: IGIV, 10% Then Placebo- Crossover Period 1 vs Arm 1: IGIV, 10% Then Placebo- Crossover Period 2 vs Arm 2: Placebo Then IGIV, 10% - Crossover Period 1 vs Arm 2: Placebo Then IGIV, 10% - Crossover Period 2: Difference in least squared means: 35.13 (95% CI 8.81 to 61.46), p = 0.005, ANOVA

Population analysed: Intent to treat

Primary outcome: Co-Primary Endpoint: Guy's Neurologic Disability Scale (GNDS) for Upper Limbs

Measure	Before Stabilization 1 n = 44	End of Stabilization 1 n = 44	End of Cross-Over 1 n = 42	End of Stabilization 2 n = 43	End of Cross-Over 2 n = 43	End of Stabilization 3 n = 36	End of the Study n = 43
IGIV then Placebo (N= 22, 22, 22, 22, 22, 17, 21)	2.0 (2.0 to 3.0)	2.0 (2.0 to 2.0)	2.0 (2.0 to 2.0)	2.0 (2.0 to 3.0)	2.5 (2.0 to 3.0)	2.0 (2.0 to 2.0)	2.0 (2.0 to 2.0)
Placebo then IGIV (N= 22, 22, 20, 21, 21, 19, 22)	2.0 (2.0 to 3.0)	2.0 (2.0 to 3.0)	2.0 (2.0 to 3.0)	2.0 (1.0 to 3.0)	2.0 (2.0 to 3.0)	2.0 (2.0 to 3.0)	2.0 (2.0 to 3.0)

Population analysed: Intent to treat

Primary outcome: Co-Primary Endpoint: Proportion of Participants With Deterioration in Guy's Neurological Disability Score (GNDS)

Measure	Deterioration After IGIV, 10% and Placebo n = 42	Deterioration After Placebo, But Not IGIV, 10% n = 42	Deterioration After IGIV, 10%, But Not Placebo n = 42	No Deterioration After IGIV, 10% or Placebo n = 42
Value	4.8 (2.0 to 2.0)	35.7 (2.0 to 3.0)	11.9 (2.0 to 3.0)	47.6 (2.0 to 3.0)

Deterioration After IGIV, 10% and Placebo vs Deterioration After Placebo, But Not IGIV, 10% vs Deterioration After IGIV, 10%, But Not Placebo vs No Deterioration After IGIV, 10% or Placebo: p = 0.021, McNemar

Population analysed: Intent to treat

19 secondary outcomes are reported in the full results.

Adverse events

Time frame: Throughout the study period, approximately three years.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IGIV, 10%	2 of 44 (4.5%)	35 of 44 (79.5%)	Not reported
Placebo	0 of 43 (0%)	33 of 43 (76.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 11971045Merkies IS, Schmitz PI, van der Meche FG, Samijn JP, van Doorn PA; Inflammatory Neuropathy Cause and Treatment (INCAT) group. Clinimetric evaluation of a new overall disability scale in immune mediated polyneuropathies. J Neurol Neurosurg Psychiatry. 2002 May;72(5):596-601. doi: 10.1136/jnnp.72.5.596.
Background: PubMed 10467380Sharrack B, Hughes RA. The Guy's Neurological Disability Scale (GNDS): a new disability measure for multiple sclerosis. Mult Scler. 1999 Aug;5(4):223-33. doi: 10.1177/135245859900500406.
Results publicationKoski CL, Schiff RI, Oh M, Lee D. Characteristics of patients with multifocal motor neuropathy enrolled in a randomized controlled trial of intravenous gammaglobulin. Poster. 63rd Annual Meeting of American Academy of Neurology (AAN), April 9-16, 2011, Honolulu, HI, USA.
Derived from this study: PubMed 38978354Li Z, Roepcke S, Franke R, Yel L. Dose-exposure-efficacy response of intravenous immunoglobulin G 10% in multifocal motor neuropathy. Ann Clin Transl Neurol. 2024 Aug;11(8):1977-1987. doi: 10.1002/acn3.52098. Epub 2024 Jul 8.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Study Director study director

Takeda

17 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Immune Globulin Intravenous (human), 10% in people with Multifocal Motor Neuropathy, run by Baxalta now part of Shire at 17 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States, Canada, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Grip Strength in the More Affected Hand (time frame: Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00666263, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2021.