Short and Long Term Fampridine Treatment in Persons With Multiple Sclerosis: Cognitive and Motor Performances
Completed Phase 4 NCT02849782
Study Description
This prospective monocentric open label trial was realized in the Laboratory of Clinical Functional Exploration of Movement at the University Hospital of Besancon. Cognitive evaluations: 7 days before fampridine treatment initiation (Pre 1), on the day of fampridine treatment initiation (Pre 2), 14 and 21 days after fampridine treatment initiation, respectively Post 1 and Post 2. Gait evaluations were assessed at Pre 1, Pre 2 and Post 1. Fampridine was prescribed according to guidelines issued by the French Health Products Safety Agency at the dose of 10 mg twice daily. Fampridine is indicated for the improvement of walking in MS patients with a walking disability (EDSS 4-6.5). A walking test is recommended to evaluate improvement after 2 weeks of treatment. According to the practitioner evaluation between Pre 2 and Post 1 (i.e. before and after fampridine treatment), patients were classified into 2 groups: responders whose clinical status was improved and non-responders whose clinical status was not improved.
Study Details
- Registry ID:
- NCT02849782
- Conditions:
- Multiple Sclerosis
- Phase:
- Phase 4
- Target Enrollment:
- 89 participants
- Start Date:
- Age Range:
- 18–80 years
- Healthy Volunteers:
- No
Study Locations (1 site)
-
CHU Jean Minjoz
Besançon, France
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