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