Multifocal Motor Neuropathy (MMN)digGNCT04356781
Do IgG Level Variations in CIDP and MMN Patients Following Initial Intravenous IVIg Treatment Correlate With Ultimate Dosing
An observational study of Multifocal Motor Neuropathy (MMN) and Chronic Inflammatory Demyelinating Polyradiculoneuropathy, run by Walton Centre NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
CIDP and MMN are part of a group of chronic inflammatory conditions that affect the peripheral nervous system. In CIDP, there is chronic inflammation of the peripheral nerves and nerve roots leading to demyelination. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multifocal Motor Neuropathy (MMN), Chronic Inflammatory Demyelinating Polyradiculoneuropathy
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Sep 2020to 30 Dec 2024
- Phase
- Observational
- 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
Study population: The study will include patients with CIDP or MMN starting IVIg under the care of neurologists in The Walton Centre.
Who may be able to join
- Adult patients with CIDP or MMN who are starting Intravenous immunoglobulin in the Walton Centre
- Informed consent
Who cannot join
- Previous Intravenous immunoglobulin use in the last year
- Age under 18
- Lack of mental capacity to consent to treatment or to study participation
- Concurrent treatment with steroids or other immunosuppressants
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Walton Centre NHS Foundation Trust
Liverpool, Merseyside, L9 7LJ
About this study
Official title: Do (IgG) Variations in Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIPD) and MMN Patients Following Initial Intravenous Immunoglobulin (IVIg) Treatment Correlate With Ultimate Dosing
CIDP and MMN are part of a group of chronic inflammatory conditions that affect the peripheral nervous system. In CIDP, there is chronic inflammation of the peripheral nerves and nerve roots leading to demyelination. The myelin sheath is vital in the rapid propagation of nerve impulses between the central nervous system and the peripheral sensory receptors and muscles. By definition CIDP must progress over 8 or more weeks and can either have a slowly progressive disease course or a relapsing course with periods of improvement. Patients typically present with a non-length dependent neuropathy that affects motor (i.e. weakness of proximal or distal muscles, fatigue, swallowing difficulty, double vision, breathing difficulties etc) and sensory function.
MMN is a similar condition to CIDP. It is an autoimmune demyelinating neuropathy that leads to slowly progressive asymmetrical weakness that worsens over years without treatment.
IVIg is a recognised treatment for CIDP and MMN. A standard starting dose of 2 g/kg/course, spread over 2-5 days, has been widely used in both research and clinical practice. Due to the chronic nature of CIDP and MMN, most patients with these conditions require repeated doses to avoid relapse, but the frequency of courses and the total dose of IVIg per course required to achieve a steady state varies between patients. Given the modest risks involved with IVIg and its cost, the lowest possible dose and frequency of administration are preferred. Current strategies to reduce dose and frequency involve assessing clinical response to lower doses, but this is both time consuming and imprecise.
Read the detailed description
The study is designed to slot into normal clinical care, with some extra blood tests performed at times patients would already be attending hospital. An extra blood test is desired 1 week following initial IVIg treatment which would require an extra visit, but this is an optional part of the study.
- Identification of suitable participant: patient with CIDP or MMN for whom treatment with IVIg has been decided upon by their treating neurologist.
- Provision of information leaflet and taking of consent. Blood test for Immunoglobulins (Igs), FBC, U\&E, LFT and ESR will be taken before initial treatment with 2 g/kg IVIg; this is all part of usual care.
- 5-30 min following final infusion of first course of IVIg, a blood test for Igs, FBC, U\&E, LFT and ESR will be taken.
- If the patient is willing to make an extra visit 7 days after day 1 of IVIg treatment, they will attend for further Igs, FBC, U\&E, LFT and ESR.
- When the patient attends at 2 weeks for post-IVIg assessment as part of usual care, a blood test for Igs, FBC, U\&E, LFT and ESR will be measured again.
- Usual process of IVIg treatment optimisation will then occur (as practised at the Walton Centre). This is part of usual care, with determination of IVIg dosing interval following clinical optimisation by dose suspension, followed by restabilisation and subsequent dose reductions to determine minimum effective dose.
- At the 3rd consecutive infusion of IVIg at the minimum effective dose, a pre-IVIg (trough) level of Igs will be taken for the minimum effective IgG level alongside FBC, U\&E, LFT and ESR.
- Statistical analysis looking for correlations between the initial ∆IgG values and the final dose and dosing interval of IVIg will be undertaken.
- Conditions
- Multifocal Motor Neuropathy (MMN), Chronic Inflammatory Demyelinating Polyradiculoneuropathy
- Keywords
- CIDP, IgG, Immunoglobulin, IVIg, transfusion reaction
- Medical subject headings
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, Transfusion Reaction
What is being measured
The primary outcome is the main question the study is designed to answer.
Link between IgG levels in the blood of patients with CIDP and MMN
Our primary research objective is to look for a link between ∆IgG levels in the blood of patients with CIDP and MMN following initial IVIg treatment and the ultimate dose required based on clinical response.
Other blood tests performed at the time of the IgG level include FBC, U\&E, LFT and ESR (a measure of plasma viscosity) and will allow a look at the effect of IVIg on these parameters. This could provide clarity as there is much variation in practice as to how often routine blood tests such as FBC, U\&E and LFT should be performed in IVIg patients, due to concerns that in some patients there may be biochemical side effects of IVIg treatment. Plasma viscosity may give an indication of risk of thrombotic side effects with IVIg and lead to guidance about, for example, when it is safe to fly after IVIg treatment. Clinical response to treatment will also be recorded
Measured: 2 years
Relationship between IgG and other variables
Secondary analyses of the data collected will look at relationships between ∆IgG and other variables recorded in the data collection. This would include the demographics of the study population, and the severity and type of their disease.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start28 Sep 2020
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multifocal Motor Neuropathy (MMN)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walton Centre NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Grifols, S.A.
- Responsible party
- Sponsor
- Investigators
- James Holt, Principal investigator, Walton Centre NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04356781
- Sponsor's protocol ID
- RG280-19
- Acronym
- digG
- Status last verified
- Mar 2025
- First submitted
- 17 Apr 2020
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do (IgG) Variations in Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIPD) and MMN Patients Following Initial Intravenous Immunoglobulin (IVIg) Treatment Correlate With Ultimate Dosing
- ClinicalTrials.gov ID
- NCT04356781
- Acronym / sponsor ID
- digG / RG280-19
- Conditions
- Multifocal Motor Neuropathy (MMN), Chronic Inflammatory Demyelinating Polyradiculoneuropathy
- Keywords
- CIDP, IgG, Immunoglobulin, IVIg, transfusion reaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Walton Centre NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Instituto Grifols, S.A.
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 22 Apr 2020 (actual)
- 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.
CIDP and MMN are part of a group of chronic inflammatory conditions that affect the peripheral nervous system. In CIDP, there is chronic inflammation of the peripheral nerves and nerve roots leading to demyelination. The myelin sheath is vital in the rapid propagation of nerve impulses between the central nervous system and the peripheral sensory receptors and muscles. By definition CIDP must progress over 8 or more weeks and can either have a slowly progressive disease course or a relapsing course with periods of improvement. Patients typically present with a non-length dependent neuropathy that affects motor (i.e. weakness of proximal or distal muscles, fatigue, swallowing difficulty, double vision, breathing difficulties etc) and sensory function.
MMN is a similar condition to CIDP. It is an autoimmune demyelinating neuropathy that leads to slowly progressive asymmetrical weakness that worsens over years without treatment.
IVIg is a recognised treatment for CIDP and MMN. A standard starting dose of 2 g/kg/course, spread over 2-5 days, has been widely used in both research and clinical practice. Due to the chronic nature of CIDP and MMN, most patients with these conditions require repeated doses to avoid relapse, but the frequency of courses and the total dose of IVIg per course required to achieve a steady state varies between patients. Given the modest risks involved with IVIg and its cost, the lowest possible dose and frequency of administration are preferred. Current strategies to reduce dose and frequency involve assessing clinical response to lower doses, but this is both time consuming and imprecise.
Detailed description
The study is designed to slot into normal clinical care, with some extra blood tests performed at times patients would already be attending hospital. An extra blood test is desired 1 week following initial IVIg treatment which would require an extra visit, but this is an optional part of the study.
- Identification of suitable participant: patient with CIDP or MMN for whom treatment with IVIg has been decided upon by their treating neurologist.
- Provision of information leaflet and taking of consent. Blood test for Immunoglobulins (Igs), FBC, U\&E, LFT and ESR will be taken before initial treatment with 2 g/kg IVIg; this is all part of usual care.
- 5-30 min following final infusion of first course of IVIg, a blood test for Igs, FBC, U\&E, LFT and ESR will be taken.
- If the patient is willing to make an extra visit 7 days after day 1 of IVIg treatment, they will attend for further Igs, FBC, U\&E, LFT and ESR.
- When the patient attends at 2 weeks for post-IVIg assessment as part of usual care, a blood test for Igs, FBC, U\&E, LFT and ESR will be measured again.
- Usual process of IVIg treatment optimisation will then occur (as practised at the Walton Centre). This is part of usual care, with determination of IVIg dosing interval following clinical optimisation by dose suspension, followed by restabilisation and subsequent dose reductions to determine minimum effective dose.
- At the 3rd consecutive infusion of IVIg at the minimum effective dose, a pre-IVIg (trough) level of Igs will be taken for the minimum effective IgG level alongside FBC, U\&E, LFT and ESR.
- Statistical analysis looking for correlations between the initial ∆IgG values and the final dose and dosing interval of IVIg will be undertaken.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include patients with CIDP or MMN starting IVIg under the care of neurologists in The Walton Centre.
Key inclusion criteria (2 listed)
- Adult patients with CIDP or MMN who are starting Intravenous immunoglobulin in the Walton Centre
- Informed consent
Key exclusion criteria (4 listed)
- Previous Intravenous immunoglobulin use in the last year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Link between IgG levels in the blood of patients with CIDP and MMN
Time frame: 2 years
Our primary research objective is to look for a link between ∆IgG levels in the blood of patients with CIDP and MMN following initial IVIg treatment and the ultimate dose required based on clinical response. Other blood tests performed at the time of the IgG level include FBC, U\&E, LFT and ESR (a measure of plasma viscosity) and will allow a look at the effect of IVIg on these parameters. This could provide clarity as there is much variation in practice as to how often routine blood tests such as FBC, U\&E and LFT should be performed in IVIg patients, due to concerns that in some patients there may be biochemical side effects of IVIg treatment. Plasma viscosity may give an indication of risk of thrombotic side effects with IVIg and lead to guidance about, for example, when it is safe to fly after IVIg treatment. Clinical response to treatment will also be recorded
Relationship between IgG and other variables
Time frame: 2 years
Secondary analyses of the data collected will look at relationships between ∆IgG and other variables recorded in the data collection. This would include the demographics of the study population, and the severity and type of their disease.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
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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.
James Holt principal investigator
Walton Centre NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multifocal Motor Neuropathy (MMN) and Chronic Inflammatory Demyelinating Polyradiculoneuropathy, run by Walton Centre NHS Foundation Trust at 1 site in United Kingdom.
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 2 inclusion and 4 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 17 Feb 2026. 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 United Kingdom. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Link between IgG levels in the blood of patients with CIDP and MMN (time frame: 2 years). The study lists 2 primary outcomes in all. 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 17 Feb 2026.