CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 89 enrolled
Drug / intervention
Fampridinedrug
Likely dose
Fampridine 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02849782
NCT02849782Phase 4Completed

Short and Long Term Fampridine Treatment in Persons With Multiple Sclerosis: Cognitive and Motor Performances

Centre Hospitalier Universitaire de Besancon·interventional·Posted Jul 29, 2016·Updated Feb 2, 2021

In Brief

A Phase 4 clinical trial evaluating Fampridine for Multiple Sclerosis. Completed, enrolled 89 participants across 1 site.

Detailed Summary

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 29, 2016
Enrollment StartFeb 4, 2014
Primary CompletionMar 1, 2019
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 9.9 years ago

Interventions

Fampridinedrug

Oral intake of 10 mg twice daily