MMNNCT04015934
Predictive Factors of Long Term Outcome in MMN
An observational study of MMN, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The cornerstone treatment for multifocal motor neuropathy (MMN), a rare and disabling dysimmune neuropathy, is intravenous immunoglobulin (IVIg). The aim of this study is to identify prognostic factors of poor outcome. Data were retrospectively collected from MNN patients in three French centers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MMN
- How many people
- 54 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2018to 1 Feb 2019
- 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: MMN patients
Who may be able to join
- diagnosis of MNN following the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) Guideline criteria 2010
Who cannot join
- missing data
- clinical progression features suggested another inflammatory neuropathy,
- immunosuppressive agents for another pathology.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictive Factors Identification of Long-term Outcome in Multifocal Motor Neuropathy (MMN) Treated With Intravenous Immunoglobulin (IVIG)
The cornerstone treatment for multifocal motor neuropathy (MMN), a rare and disabling dysimmune neuropathy, is intravenous immunoglobulin (IVIg). The aim of this study is to identify prognostic factors of poor outcome.
Data were retrospectively collected from MNN patients in three French centers. Patients were divided into two groups: a good outcome group and a poor outcome group. Demographic, clinical, biological and nerve conduction study features of MMN patients were analyzed. Identification of prognostic factors in MMN could help develop personalized treatment.
Read the detailed description
The cornerstone treatment for multifocal motor neuropathy (MMN), a rare and disabling dysimmune neuropathy, is intravenous immunoglobulin (IVIg). However, 10% of patients progress despite treatment. The aim of this study is to identify prognostic factors of poor outcome.
Data were retrospectively collected from MNN patients in three French centers. Patients were divided into two groups: a good outcome group (patients in remission without IVIg or with spaced IVIg courses), and a poor outcome group (patients dependent on continuous IVIg treatment or deteriorating despite IVIg). Investigators searched predictive factors of long-term outcome in MMN. They studied demographic, clinical, biological and nerve conduction study features of MMN patients.Identification of prognostic factors in MMN could help develop personalized treatment by selecting patients eligible for immunosuppressive drugs before IVIg dependence or progression.
- Conditions
- MMN
- Keywords
- predictive factors
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of deteriorating or strongly dependant IVIg NMM
Measured: inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start1 Apr 2018
- Primary completion1 Nov 2018
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MMNStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Régional Metz-Thionville, Hospices Civils de Lyon
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04015934
- Sponsor's protocol ID
- NMMBC
- Status last verified
- May 2019
- First submitted
- 31 May 2019
- Last updated
- 11 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors Identification of Long-term Outcome in Multifocal Motor Neuropathy (MMN) Treated With Intravenous Immunoglobulin (IVIG)
- ClinicalTrials.gov ID
- NCT04015934
- Acronym / sponsor ID
- NMMBC
- Conditions
- MMN
- Keywords
- predictive factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- Centre Hospitalier Régional Metz-Thionville, Hospices Civils de Lyon
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 11 Jul 2019 (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.
The cornerstone treatment for multifocal motor neuropathy (MMN), a rare and disabling dysimmune neuropathy, is intravenous immunoglobulin (IVIg). The aim of this study is to identify prognostic factors of poor outcome.
Data were retrospectively collected from MNN patients in three French centers. Patients were divided into two groups: a good outcome group and a poor outcome group. Demographic, clinical, biological and nerve conduction study features of MMN patients were analyzed. Identification of prognostic factors in MMN could help develop personalized treatment.
Detailed description
The cornerstone treatment for multifocal motor neuropathy (MMN), a rare and disabling dysimmune neuropathy, is intravenous immunoglobulin (IVIg). However, 10% of patients progress despite treatment. The aim of this study is to identify prognostic factors of poor outcome.
Data were retrospectively collected from MNN patients in three French centers. Patients were divided into two groups: a good outcome group (patients in remission without IVIg or with spaced IVIg courses), and a poor outcome group (patients dependent on continuous IVIg treatment or deteriorating despite IVIg). Investigators searched predictive factors of long-term outcome in MMN. They studied demographic, clinical, biological and nerve conduction study features of MMN patients.Identification of prognostic factors in MMN could help develop personalized treatment by selecting patients eligible for immunosuppressive drugs before IVIg dependence or progression.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MMN patients
Key inclusion criteria (1 listed)
- diagnosis of MNN following the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) Guideline criteria 2010
Key exclusion criteria (3 listed)
- missing data
- clinical progression features suggested another inflammatory neuropathy,
- immunosuppressive agents for another pathology.
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
Presence of deteriorating or strongly dependant IVIg NMM
Time frame: inclusion
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 11 Jul 2019.
- Individual participant dataSharing planned: No
Related trials for MMN
Active, not recruitingObservational study
A Prospective Longitudinal Study in Adults With Multifocal Motor Neuropathy
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A Study to Assess the Effect of Empasiprubart on Nerve Morphology by Ultrasound in Adults With Multifocal Motor Neuropathy
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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
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Vasculitic Neuropathy
Active, not recruitingPhase 2
A Clinical Study to Evaluate DNTH103 in Adults With Multifocal Motor Neuropathy
Multifocal Motor Neuropathy
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.
The record lists no contact. Use the official record to reach the sponsor.
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 MMN, run by Central Hospital, Nancy, France at 1 site in France.
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 1 inclusion and 3 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 11 Jul 2019. 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 France. 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?
Presence of deteriorating or strongly dependant IVIg NMM (time frame: inclusion). 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 Jul 2019.