SERENDEM : MD1003 in Patients Suffering From Demyelinating Neuropathies, an Open Label Pilot Study
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ClinicalTrials.gov Identifier: NCT02967679
Recruitment Status : Unknown
Verified November 2016 by MedDay Pharmaceuticals SA. Recruitment status was: Recruiting
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Ages Eligible for Study:
20 Years to 85 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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
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.
Peripheral Nervous System Diseases
Nerve Compression Syndromes
Hereditary Sensory and Motor Neuropathy
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Nervous System Diseases
Nervous System Malformations
Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn
Autoimmune Diseases of the Nervous System
Immune System Diseases