Peripheral NeuropathyPhase 4IDIDMNCT02372149
IVIg for Demyelination in Diabetes Mellitus
A Phase 4 study testing 10% intravenous immunoglobulin (IVIg) and 0.9% sodium chloride in people with Peripheral Neuropathy and Diabetes Mellitus, run by University of Toronto at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether intravenous immunoglobulin (IVIg) is an effective intervention for patients with diabetes, peripheral neuropathy, and demyelination on nerve conduction studies. All patients will receive both IVIg and placebo for 3 months each, with a 3 month washout period in between. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Neuropathy, Diabetes Mellitus, Chronic Inflammatory Demyelinating Polyneuropathy
- What is being tested?
- 10% intravenous immunoglobulin (IVIg) and 0.9% sodium chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2015to Feb 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Age ≥18 years.
- Diabetes, as per American Diabetes Association Criteria.
- Clinical evidence of polyneuropathy and NCS shows 2 separate motor nerves (median, ulnar, tibial, or peroneal) which meet criteria for demyelination, defined as follows:
- Conduction velocity <90% lower limit of normal (LLN), distal latency >110% upper limit of normal (ULN), or minimal F-wave latency >110% ULN
- The changes are not exclusively due to median neuropathy at the wrist, ulnar neuropathy at the elbow, or peroneal neuropathy at the fibular head.
- Clinical suspicion of possible demyelinating polyneuropathy (CIDP).
Who cannot join
- Pregnant patients, or those of childbearing potential not using contraception.
- Patients <18 years of age.
- Presence of an alternative etiology of peripheral neuropathy, such as: hereditary neuropathies (Charcot Marie-Tooth disease); B-vitamin deficiency- or excess-related neuropathy; uremic neuropathy; neuropathy secondary to monoclonal gammopathy; history of cancer- or chemotherapy-related neuropathy; other toxin exposures; and alcoholic neuropathy.
- Contraindication to IVIg, including: history of recurrent thrombosis, immunoglobulin A deficiency, or severe hypersensitivity reaction to IVIg in past, renal failure, recurrent deep venous thrombosis, pulmonary embolus, stroke, or myocardial infarction.
- Presence of serious or unstable medical condition, which may preclude study completion or lead to inability to tolerate IVIg. This may include active heart failure, uncontrolled hypertension, or severe anemia, among other conditions.
- Presence of concomitant neurological illness, which may confound evaluation.
- Fails or unable to provide informed consent.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Toronto General Hospital / Toronto Western Hospital
Toronto, Ontario, M5G 2C4
Eduardo Ng, MD, 416-340-4184, eduardo.ng@uhn.ca
About this study
Official title: Treatment With Gamunex 10% Intravenous Immunoglobulin (IVIg) for Patients With Demyelination and Diabetes Mellitus: A Blinded, Placebo-Controlled Crossover Pilot Study
The purpose of this study is to determine whether intravenous immunoglobulin (IVIg) is an effective intervention for patients with diabetes, peripheral neuropathy, and demyelination on nerve conduction studies. All patients will receive both IVIg and placebo for 3 months each, with a 3 month washout period in between.
Read the detailed description
There is a knowledge gap with regards to the appropriate method of detecting and treating chronic inflammatory demyelinating polyneuropathy (CIDP), in patients with co-existent diabetes. In this pilot study the investigators plan to examine the overlap between diabetic polyneuropathy and CIDP by treating patients with diabetes and demyelinating abnormalities using IVIg. The investigators will enroll diabetes patients with a broad spectrum of demyelinating abnormalities.
The proposed trial will be an explanatory, blinded, single-centre, superiority, randomized controlled cross-over trial. Each patient will receive 3 months of 10% intravenous immunoglobulin and 3 months of placebo (0.9% sodium chloride in water) with a 3-month washout period. The primary outcome measure is the mean change in ONLS (Overall Neuropathy Limitation Scale), a measure of disability in polyneuropathy; however secondary outcome measures will consider impairments and quality of life.
- Conditions
- Peripheral Neuropathy, Diabetes Mellitus, Chronic Inflammatory Demyelinating Polyneuropathy
- Being tested
- 10% intravenous immunoglobulin (IVIg), 0.9% sodium chloride
- Medical subject headings
- Peripheral Nervous System Diseases, Diabetes Mellitus, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10% intravenous immunoglobulin (IVIg)Drug
Also called Gamunex
0.9% sodium chlorideDrug
Also called Normal Saline
| Study group | Role | What they receive |
|---|---|---|
| IVIg--Washout--0.9% NaCl (CROSSOVER) | Experimental | 1. 10% caprylate-chromatography purified intravenous immunoglobulin (IVIg) Initial dose: 1.0gm/kg/day for 2 days (maximum 80gm/day). Maintenance dose (monthly x3): 1.0mg/kg/day for 1 day (maximum 80gm/day)
2. Washout period
3. 0.9% sodium chloride in water - equal volume to IVIg - Monthly x4 Receives: Drug: 10% intravenous immunoglobulin (IVIg); Drug: 0.9% sodium chloride |
| 0.9% NaCl--Washout--IVIg (CROSSOVER) | Experimental | 1. 0.9% sodium chloride in water - equal volume to IVIg - Monthly x4
2. Washout period
3. 10% caprylate-chromatography purified intravenous immunoglobulin (IVIg) Initial dose: 1.0gm/kg/day for 2 days (maximum 80gm/day). Maintenance dose (monthly x3): 1.0mg/kg/day for 1 day (maximum 80gm/day) Receives: Drug: 10% intravenous immunoglobulin (IVIg); Drug: 0.9% sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Overall Neuropathy Limitations Score (ONLS) after 3 months
ONLS score will be measured before and after 3 months of IVIg / placebo
Measured: Baseline and 3 months
Secondary outcomes (6)
Change in Rasch-Built Overall Disability Scale (R-ODS) after 3 months
R-ODS score will be measured before and after 3 months of IVIg / placebo
Measured: Baseline and 3 months
Change in Nerve Conduction Studies (NCS) after 3 months
Changes in NCS parameters will be compared before and after 3 months of IVIg / placebo
Measured: Baseline and 3 months
Change in Medical Research Council (MRC) Sum Score after 3 months
MRC sum score will be compared before and after 3 months of IVIg / placebo
Measured: Baseline and 3 months
Change in Grip Strength after 3 months
Grip strength (using Martin vigorimeter) will be compared before and after 3 months of IVIg / placebo
Measured: Baseline and 3 months
Change in Short Form 36 (SF-36) Quality of Life after 3 months
SF-36 will be compared before and after 3 months of IVIg / placebo
Measured: Baseline and 3 months
Adverse Events
Number of adverse events and serious adverse events within 30 days of IVIg administration
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto
- Responsible party
- Principal investigator, Ari Breiner, MD, University of Toronto
- Investigators
- Ari Breiner, MD, FRCPC, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02372149
- Sponsor's protocol ID
- 14-8297-B
- Acronym
- IDIDM
- Status last verified
- Nov 2016
- First submitted
- 12 Feb 2015
- Last updated
- 11 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment With Gamunex 10% Intravenous Immunoglobulin (IVIg) for Patients With Demyelination and Diabetes Mellitus: A Blinded, Placebo-Controlled Crossover Pilot Study
- ClinicalTrials.gov ID
- NCT02372149
- Acronym / sponsor ID
- IDIDM / 14-8297-B
- Conditions
- Peripheral Neuropathy, Diabetes Mellitus, Chronic Inflammatory Demyelinating Polyneuropathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- University Health Network, Toronto
- Study start
- Feb 2015
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 26 Feb 2015 (estimated)
- Results
- Not posted in the source record
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 this study is to determine whether intravenous immunoglobulin (IVIg) is an effective intervention for patients with diabetes, peripheral neuropathy, and demyelination on nerve conduction studies. All patients will receive both IVIg and placebo for 3 months each, with a 3 month washout period in between.
Detailed description
There is a knowledge gap with regards to the appropriate method of detecting and treating chronic inflammatory demyelinating polyneuropathy (CIDP), in patients with co-existent diabetes. In this pilot study the investigators plan to examine the overlap between diabetic polyneuropathy and CIDP by treating patients with diabetes and demyelinating abnormalities using IVIg. The investigators will enroll diabetes patients with a broad spectrum of demyelinating abnormalities.
The proposed trial will be an explanatory, blinded, single-centre, superiority, randomized controlled cross-over trial. Each patient will receive 3 months of 10% intravenous immunoglobulin and 3 months of placebo (0.9% sodium chloride in water) with a 3-month washout period. The primary outcome measure is the mean change in ONLS (Overall Neuropathy Limitation Scale), a measure of disability in polyneuropathy; however secondary outcome measures will consider impairments and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVIg--Washout--0.9% NaCl (CROSSOVER) | Experimental | Drug: 10% intravenous immunoglobulin (IVIg), Drug: 0.9% sodium chloride1. 10% caprylate-chromatography purified intravenous immunoglobulin (IVIg) Initial dose: 1.0gm/kg/day for 2 days (maximum 80gm/day). Maintenance dose (monthly x3): 1.0mg/kg/day for 1 day (maximum 80gm/day) 2. Washout period 3. 0.9% sodium chloride in water - equal volume to IVIg - Monthly x4 |
| 0.9% NaCl--Washout--IVIg (CROSSOVER) | Experimental | Drug: 10% intravenous immunoglobulin (IVIg), Drug: 0.9% sodium chloride1. 0.9% sodium chloride in water - equal volume to IVIg - Monthly x4 2. Washout period 3. 10% caprylate-chromatography purified intravenous immunoglobulin (IVIg) Initial dose: 1.0gm/kg/day for 2 days (maximum 80gm/day). Maintenance dose (monthly x3): 1.0mg/kg/day for 1 day (maximum 80gm/day) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years.
- Diabetes, as per American Diabetes Association Criteria.
- Clinical evidence of polyneuropathy and NCS shows 2 separate motor nerves (median, ulnar, tibial, or peroneal) which meet criteria for demyelination, defined as follows:
- Clinical suspicion of possible demyelinating polyneuropathy (CIDP).
Key exclusion criteria (7 listed)
- Pregnant patients, or those of childbearing potential not using contraception.
- Patients <18 years of age.
- Presence of an alternative etiology of peripheral neuropathy, such as: hereditary neuropathies (Charcot Marie-Tooth disease); B-vitamin deficiency- or excess-related neuropathy; uremic neuropathy; neuropathy secondary to monoclonal gammopathy; history of cancer- or chemotherapy-related neuropathy; other toxin exposures; and alcoholic neuropathy.
- Contraindication to IVIg, including: history of recurrent thrombosis, immunoglobulin A deficiency, or severe hypersensitivity reaction to IVIg in past, renal failure, recurrent deep venous thrombosis, pulmonary embolus, stroke, or myocardial infarction.
- Presence of serious or unstable medical condition, which may preclude study completion or lead to inability to tolerate IVIg. This may include active heart failure, uncontrolled hypertension, or severe anemia, among other conditions.
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 |
|---|---|---|
| 10% intravenous immunoglobulin (IVIg)Also: Gamunex | Drug | 0.9% NaCl--Washout--IVIg (CROSSOVER), IVIg--Washout--0.9% NaCl (CROSSOVER) |
| 0.9% sodium chlorideAlso: Normal Saline | Drug | 0.9% NaCl--Washout--IVIg (CROSSOVER), IVIg--Washout--0.9% NaCl (CROSSOVER) |
Primary outcome
Change in Overall Neuropathy Limitations Score (ONLS) after 3 months
Time frame: Baseline and 3 months
ONLS score will be measured before and after 3 months of IVIg / placebo
6 secondary outcomes
Change in Rasch-Built Overall Disability Scale (R-ODS) after 3 months
Time frame: Baseline and 3 months
Change in Nerve Conduction Studies (NCS) after 3 months
Time frame: Baseline and 3 months
Change in Medical Research Council (MRC) Sum Score after 3 months
Time frame: Baseline and 3 months
Change in Grip Strength after 3 months
Time frame: Baseline and 3 months
Change in Short Form 36 (SF-36) Quality of Life after 3 months
Time frame: Baseline and 3 months
Adverse Events
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2016.
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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.
Ari Breiner, MD, FRCPC principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 10% intravenous immunoglobulin (IVIg) and 0.9% sodium chloride in people with Peripheral Neuropathy and Diabetes Mellitus, run by University of Toronto at 1 site in Canada.
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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 11 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eduardo Ng, MD (416-340-4184, eduardo.ng@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Overall Neuropathy Limitations Score (ONLS) after 3 months (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Nov 2016; AzTrials last refreshed its copy on 6 Nov 2026.