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.

Multiple Sclerosis Clinical Trial

Official title:

Open-Label Extension Study to Evaluate the Safety and Tolerability of Oral Fampridine SR in Canadian Subjects With Multiple Sclerosis Who Participated in Acorda Extension Trials

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01235221
• Other study ID #: 218MS301
• Status: Completed
• Phase: Phase 3
• First received: November 4, 2010
• Last updated: July 3, 2014
• Start date: December 2010
• Est. completion date: June 2012

Study information

• Verified date: July 2014
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Key Inclusion Criteria :

1. Previously enrolled in 1 of the 3 Acorda-sponsored studies (MS-F202EXT, MS-F203EXT, and MS-F204EXT) and continuing to receive fampridine-SR.

2. Willing to comply with the required scheduling and assessments of the protocol.

3. Female subjects of childbearing potential, regardless of sexual activity, must have a negative urine pregnancy test, and must practice effective contraception during the study and be willing and able to continue contraception for 1 month after their last dose of study treatment.

Key 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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• BIIB041 (Fampridine-SR)
10 mg twice a day (BID) sustained-release (SR) tablets by mouth for up to 27 months (in addition to treatment in previous studies) or until the product is commercially available, whichever comes first. Doses of study treatment must be spaced at least 12 hours apart.

Locations

Country	Name	City	State
Canada	Foothills Medical Center	Calgary	Alberta
Canada	River Valley Health	Fredericton	New Brunswick
Canada	QEII Health Sciences Centre	Halifax	Nova Scotia
Canada	Ottawa Hospital General Campus	Ottawa	Ontario
Canada	University of British Columbia	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Biogen	Acorda Therapeutics

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes