Clinical trial NCT01235221: 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.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
Collaborators: name: Acorda Therapeutics
First posted: 2010-11-05
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Adverse events (AEs) and serious adverse events (SAEs) as well as Changes in vital signs and clinical laboratory assessments
timeFrame: From Screening (Day 0) to Termination (Month 27)
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Center
state: Alberta
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Fredericton
country: Canada
facility: River Valley Health
state: New Brunswick
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
state: Nova Scotia
city: Ottawa
country: Canada
facility: Ottawa Hospital General Campus
state: Ontario
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: