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Predictive Factors of Long Term Outcome in MMN
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.
| Condition or disease |
|---|
| MMN |
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 Type : | Observational |
| Actual Enrollment : | 54 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | Predictive Factors Identification of Long-term Outcome in Multifocal Motor Neuropathy (MMN) Treated With Intravenous Immunoglobulin (IVIG) |
| Actual Study Start Date : | April 1, 2018 |
| Actual Primary Completion Date : | November 1, 2018 |
| Actual Study Completion Date : | February 1, 2019 |
- Presence of deteriorating or strongly dependant IVIg NMM [ Time Frame: inclusion ]
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- diagnosis of MNN following the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) Guideline criteria 2010
Exclusion Criteria:
- missing data
- clinical progression features suggested another inflammatory neuropathy,
- immunosuppressive agents for another pathology.
| France | |
| Central Hospital | |
| Nancy, France, 54000 | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 31, 2019 | ||||
| First Posted Date | July 11, 2019 | ||||
| Last Update Posted Date | July 11, 2019 | ||||
| Actual Study Start Date | April 1, 2018 | ||||
| Actual Primary Completion Date | November 1, 2018 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Presence of deteriorating or strongly dependant IVIg NMM [ Time Frame: inclusion ] | ||||
| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Predictive Factors of Long Term Outcome in MMN | ||||
| Official Title | Predictive Factors Identification of Long-term Outcome in Multifocal Motor Neuropathy (MMN) Treated With Intravenous Immunoglobulin (IVIG) | ||||
| Brief 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. 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. |
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| 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. |
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| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | MMN patients | ||||
| Condition | MMN | ||||
| Intervention | Not Provided | ||||
| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
54 | ||||
| Original Actual Enrollment | Same as current | ||||
| Actual Study Completion Date | February 1, 2019 | ||||
| Actual Primary Completion Date | November 1, 2018 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT04015934 | ||||
| Other Study ID Numbers | NMMBC | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Central Hospital, Nancy, France | ||||
| Study Sponsor | Central Hospital, Nancy, France | ||||
| Collaborators |
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| Investigators | Not Provided | ||||
| PRS Account | Central Hospital, Nancy, France | ||||
| Verification Date | May 2019 | ||||
