Open Label Extension Study to Evaluate the Safety and Tolerability of Oral Fampridine-Sustained Release (SR) in Canadian Participants With Multiple Sclerosis Who Participated in Acorda Extension Trials.

Phase 3

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: BIIB041 (Fampridine-SR)

• Registration Number: NCT01235221
• Lead Sponsor: Biogen

Brief Summary

The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB041 (fampridine-sustained release (SR)) treatment in Canadian participants with multiple sclerosis (MS) who previously participated in the registrational and extension studies conducted by Acorda. Those studies include NCT00654927 (MS-F202EXT), NCT00648908 (MS-F203EXT) and NCT00649792 (MS-F204EXT).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-04
• Study First Submitted QC: 2010-11-04
• Study First Posted: 2010-11-05
• Study Start: 2010-12
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-03
• Last Update Posted: 2014-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

Not provided

Exclusion Criteria

1. Discontinued prematurely from the preceding study ((MS-F202EXT, MS-F203EXT, or MS-F204EXT).
2. Any prior history of seizure, epilepsy, or other convulsive disorder.
3. Any clinically significant abnormal laboratory values.
4. New history of moderate or severe renal impairment.
5. New history of angina, uncontrolled hypertension, clinically significant cardiac arrhythmias, or any other clinically significant cardiovascular abnormality, as judged by the Investigator.
6. Any significant change in overall health that would preclude subject's participation in the study, in the opinion of the Investigator.
7. Known allergy to pyridine-containing substances or any of the inactive ingredients of the fampridine-SR tablet
8. Received an investigational drug, except fampridine-SR under the preceding study (MS-F202EXT, MS-F203EXT, or MS-F204EXT), within the last 30 days, or the subject is scheduled to enroll in an investigational drug at any time during the study.
9. A history of drug or alcohol abuse within the past year.
10. Treatment with other forms of fampridine or 4-AP (e.g., compounded formulation of 4-AP) or 3,4-diaminopyridine (3,4-DAP).

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BIIB041 (Fampridine-SR)	BIIB041 (Fampridine-SR)	Participants take 10 mg sustained-release tablets of fampridine twice daily for up to 27 months or until the product is commercially available.

Primary Outcome Measures

Name	Time	Method
Adverse events (AEs) and serious adverse events (SAEs) as well as Changes in vital signs and clinical laboratory assessments	From Screening (Day 0) to Termination (Month 27)

Trial Locations

Locations (5)

University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada

Ottawa Hospital General Campus; 🇨🇦 Ottawa, Ontario, Canada

Foothills Medical Center; 🇨🇦 Calgary, Alberta, Canada

River Valley Health; 🇨🇦 Fredericton, New Brunswick, Canada

QEII Health Sciences Centre; 🇨🇦 Halifax, Nova Scotia, Canada