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SERENDEM : MD1003 in Patients Suffering From Demyelinating Neuropathies, an Open Label Pilot Study | Clinical Trials | Clareo Health

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SERENDEM : MD1003 in Patients Suffering From Demyelinating Neuropathies, an Open Label Pilot Study

SERENDEM Study: MD1003 in Patients Suffering From Demyelinating Neuropathies, an Open Label Pilot Study

NCT02967679•MedDay Pharmaceuticals SA

View on ClinicalTrials.gov

Summary

The single-center, open-label Phase II study has the objective of assess the effect of MD1003 on motor and sensory conduction in patients suffering from demyelinating polyneuropathies in 15 subjects.

Eligibility

Age

20 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male and female aged between 20 and 85 years.
•Patients fulfilling one of the following diagnosis:
•Five patients with chronic inflammatory demyelinating polyneuropathy on both clinical and neurophysiological grounds.
•Five patients with proven genetic diagnosis of CMT1a or CMT1b
•Five patients with anti-MAG polyneuropathy.
•Electrophysiological parameters worsening for the past 3 years
•Available EMG record, performed during the past 6 months to assess variability of NCV parameters
•Signed and dated written informed consent to participate in the study in accordance with local regulations
•Likely to be able to participate in all scheduled evaluation and complete all required study procedures,
•In the opinion of the investigator, the patient will be compliant and have a high probability of completing the study.
+1 more criteria

Exclusion Criteria

•Any general chronic handicapping disease other than peripheral neuropathy
•Impossibility to perform the 10 meters walking test
•Impossibility to assess electrophysiological parameters
•Patients with uncontrolled hepatic disorder, renal or cardiovascular disease, or cancer,
•Patients with hypersensitivity to MD1003 excipients (lactose)
•Laboratory tests out of normal range according to the reference laboratory values. Deviations may be accepted if considered by the investigator as not clinically significant with regards to the study continuation,
•Patients with history or presence of alcohol abuse or drug addiction,
•Patients likely to be non-compliant to the study procedures or for whom a long-term follow-up seems to be difficult to achieve.
•Any new medication for neuropathy initiated less than 3 months prior to inclusion. For CIDP patients, relapse in the past 3 months before inclusion.
•Not easily contactable by the investigator in case of emergency or not capable to call the investigator
+1 more criteria

Locations (1)

Hôpital Henri Mondor, Créteil, France

Créteil, France

Key Dates

Start Date

December 5, 2016

Primary Completion Date

March 18, 2019

Completion Date

March 18, 2019

Last Updated

November 2, 2020

Enrollment

ACTUAL participants

Conditions

Chronic Inflammatory Demyelinating PolyneuropathyPeripheral NeuropathyCharcot-Marie-Tooth DiseaseCharcot-Marie-Tooth Disease Type 1ACharcot-Marie-Tooth Disease, Type 1BAnti-MAG Neuropathy

Interventions

MD1003

DRUG

A Study Investigating Intravenous Human Normal Immune Globulin (IGIV) 10% in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

NCT06752356

Chronic Inflammatory Demyelinating Polyneuropathy

View study

RECRUITING

Longitudinal Biomarkers With Selected Outcome Measures In CMT

NCT06794489

CMT1ACMT (Charcot Marie Tooth Disease)+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 2, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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SERENDEM : MD1003 in Patients Suffering From Demyelinating Neuropathies, an Open Label Pilot Study

Inclusion Criteria

Exclusion Criteria

A Study Investigating Intravenous Human Normal Immune Globulin (IGIV) 10% in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Longitudinal Biomarkers With Selected Outcome Measures In CMT

A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP

Study on the Efficacy and Safety of Mecobalamin in Preventing Taxane-related Peripheral Neuropathy

Use of PEA and Scutellaria in Synergy With Therapeutic Exercise in Chemotherapy-induced Peripheral Neuropathy (CIPN): a Clinical Trial

Patient-identified Values as Outcome Targets (PIVOT) Feasibility Pilot Trial