Short and Long Term Multiple Outcomes in Persons With Multiple Sclerosis Treated by Fampridine.

• Status: Completed
• Trial end date: 2019-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Besancon
• Treatments: 4-Aminopyridine

Criteria

Inclusion Criteria:

• MS diagnostic regarding the modified McDonald criteria

• EDSS status between 4.0 and 6.5

• patients able to walk during 6 minutes

Exclusion Criteria:

• increasing MS symptoms during the previous 60 days

• history of epilepsy or epileptic seizure

• immunotherapy change in the previous 60 days

• beginning anti-spastic treatment in the previous 30 days

• beginning treatment that is able to decrease fatigue symptoms in the previous 30 days

• modification of the rehabilitation program during the study

• renal insufficiency (creatinine clearance <80ml.min-1 given by the Cockroft-Gault formula)

• concomitant treatment by organic cation transporter 2 inhibitor

• hypersensitivity to fampridine