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CompletedNCT01235221Updated Jul 4, 2014

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.

A Phase 3 interventional study of BIIB041 (Fampridine-SR) in Multiple Sclerosis, sponsored by Biogen. Completed at 5 sites in Canada. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-07-04.

Sponsored by Biogen · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
38
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
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Study 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).

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Conditions studied

  • Multiple Sclerosis
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In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 38 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Biogen is the lead sponsor of 494 studies on the registry; 22 are open to participants now.

Of its 98 completed or terminated interventional studies of FDA-regulated products, 49 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    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.

    Drug: BIIB041 (Fampridine-SR)

Interventions

  • DrugBIIB041 (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.

    Also known as: Dalfampridine, Fampridine-ER, Ampyra, Fampyra, Fampridine-PR

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What researchers measure

Primary outcomes

  1. Adverse events (AEs) and serious adverse events (SAEs) as well as Changes in vital signs and clinical laboratory assessments

    Time frame: From Screening (Day 0) to Termination (Month 27)

07

Study locations

5 sites
  • Foothills Medical Center
    Calgary, Alberta, Canada
  • University of British Columbia
    Vancouver, British Columbia, Canada
  • River Valley Health
    Fredericton, New Brunswick, Canada
  • QEII Health Sciences Centre
    Halifax, Nova Scotia, Canada
  • Ottawa Hospital General Campus
    Ottawa, Ontario, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 4, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01235221
Lead sponsor
Biogen
Collaborators
Acorda Therapeutics
Responsible party
Sponsor
First posted
Nov 5, 2010
Start date
Dec 2010
Primary completion
Jun 2012
Completion
Jun 2012
Last update
Jul 4, 2014

Study contacts

Medical Director
study director · Biogen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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