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

NCT02849782 | Completed Phase 4

• 1 other identifier: API/2014/49
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis

Keywords

Gait analysis; Fampridine; Fatigue; Daily activity; Cognition

Outcome Measures

Primary Outcomes (1)

• 6 Minute Walk Test (6MWT)

  The 6MWT assessed the submaximal level of functional capacity. It was realized according to the recommendation of the American Thoracic Society. 6MWT instructions were read prior to each walk. Participants used his/her typical assistive device and walked around a circuit with 24-meters longer. If necessary, they were allowed to have a rest period and encouragement phrases were used each 30 seconds.

  Timed 21 days

Secondary Outcomes (46)

• Verbal fluencies

  Day 1

• Verbal fluencies

  7 days

• Verbal fluencies

  21 days

• Verbal fluencies

  28 days

• Verbal fluencies

  up to one year

Study Arms (2)

Fampridine responder

EXPERIMENTAL

Persons who have been diagnosed as Multiple Sclerosis according to Mc Donald Criteria : person with Multiple Sclerosis (PwMS). Fampridine was prescribed according to the guidelines issued by the French National Security Agency of Medicines and Health Products (ANSM) at the dose of 10 mg twice a day. According to official ANSM guidelines, the prescription is initially limited to 2 weeks of therapy, at which point a new assessment is performed by the medical practitioner to evaluate the clinical benefits. Fampridine responder is a PwMS with an improvement in the judgment of the practitioner.

Drug: Fampridine

Fampridine non responder

ACTIVE COMPARATOR

Persons who have been diagnosed as Multiple Sclerosis according to Mc Donald Criteria : person with Multiple Sclerosis (PwMS). Fampridine was prescribed according to the guidelines issued by the French National Security Agency of Medicines and Health Products (ANSM) at the dose of 10 mg twice a day. According to official ANSM guidelines, the prescription is initially limited to 2 weeks of therapy, at which point a new assessment is performed by the medical practitioner to evaluate the clinical benefits. Fampridine non responder is a PwMS without any improvement in the judgment of the practitioner.

Drug: Fampridine

Interventions

Fampridine DRUG

Oral intake of 10 mg twice daily

Also known as: Fampyra, code CIS : 62483787

Fampridine non responder; Fampridine responder

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• MS diagnostic regarding the modified McDonald criteria
• EDSS status between 4.0 and 6.5
• patients able to walk during 6 minutes

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

CHU Jean Minjoz

Besançon, 25030, France

Location

Related Publications (31)

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  PMID: 32634812 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue

Interventions

4-Aminopyridine

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aminopyridines; Amines; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2016
• First Posted: July 29, 2016
• Study Start: February 4, 2014
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: February 2, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)