Clinical Trial: SERENDEM : MD1003 in Patients Suffering From Demyelinating Neuropathies, an Open Label Pilot Study
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title:
Brief Summary: The primary objective of the study is to assess the effect of MD1003 on motor and sensory conduction, in patients suffering from demyelinating polyneuropathies.
Detailed Summary:
Sponsor: MedDay Pharmaceuticals SA
Current Primary Outcome:
- Motor nerve conduction velocity (m/sec) [ Time Frame: 48 weeks ]A 10% improvement for 2 out of these 4 criteria, in at least 3 out of 8 nerves will be considered as clinically meaningful.
- Distal latency (msec) [ Time Frame: 48 weeks ]A 10% improvement for 2 out of these 4 criteria, in at least 3 out of 8 nerves will be considered as clinically meaningful.
- F wave latency (msec) [ Time Frame: 48 weeks ]A 10% improvement for 2 out of these 4 criteria, in at least 3 out of 8 nerves will be considered as clinically meaningful.
- Length of motor nerve potential [ Time Frame: 48 weeks ]A 10% improvement for 2 out of these 4 criteria, in at least 3 out of 8 nerves will be considered as clinically meaningful.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- ONLS (Overall Neuropathy Limitations Scale) [ Time Frame: 48 weeks ]Secondary endpoints will be part of exploratory analyses. They will consist in studying mean change or proportions for the following clinical and electrophysiological parameters.
- Timed 10-meter walk test [ Time Frame: 48 weeks ]
- Medical Research Council (MRC) sum score [ Time Frame: 48 weeks ]
- INCAT Sensory Sum Score (ISS) [ Time Frame: 48 weeks ]
- 6-minute walk test [ Time Frame: 48 weeks ]
- Posturometry [ Time Frame: 48 weeks ]
- Supernormality (%) [ Time Frame: 48 weeks ]
- Strength-duration time constant (ms) [ Time Frame: 48 weeks ]
- Rheobase (mA) [ Time Frame: 48 weeks ]
- Refractoriness (%) [ Time Frame: 48 weeks ]
- Min-max absolute refractory period (ms) [ Time Frame: 48 weeks ]
Original Secondary Outcome: Same as current
Information By: MedDay Pharmaceuticals SA
Dates:
Date Received: November 8, 2016
Date Started: September 2016
Date Completion:
Last Updated: November 15, 2016
Last Verified: November 2016