Status:
COMPLETED
Open-Label Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) on Quality of Life as Reported by Participants With Multiple Sclerosis
Lead Sponsor:
Biogen
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
The primary objective of the study is to assess the effect of long-term treatment with prolonged-release fampridine (BIIB041) 10 mg twice daily on the physical component scale (PCS) of the Short Form ...
Detailed Description
This study has 2 components: a 4-week run-in period during which participants are treated with prolonged-release fampridine and undergo subjective and objective assessments of walking ability, the res...
Eligibility Criteria
Inclusion
- Key
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations.
- Must have a diagnosis of primary-progressive, secondary-progressive, progressive-remitting, or relapsing-remitting multiple sclerosis (MS) per revised McDonald Committee criteria (\[Polman et al, 2011\]) as defined by Lublin and Reingold \[Lublin and Reingold 1996\] of at least 3 months duration.
- Have a walking impairment as determined by the Investigator.
- Able to perform the Timed 25-foot Walk Test with or without a walking aid.
- Female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.
- Able to understand and comply with the requirements of the protocol.
- Key
Exclusion
- Known allergy to pyridine-containing substances or to any of the inactive ingredients in the prolonged-release fampridine tablet.
- Any history of seizure, epilepsy, or other convulsive disorder, with the exception of febrile seizures in childhood.
- An estimated creatinine clearance of \<80 mL/minute.
- Subject needs to take medicinal products that are inhibitors of organic cation transporter 2 (OCT2 \[e.g., cimetidine\]).
- Female subjects who are currently pregnant or who are considering becoming pregnant while participating in the study.
- Female subjects who are currently breastfeeding.
- Previous exposure to fampridine.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
901 Patients enrolled
Trial Details
Trial ID
NCT01480076
Start Date
February 1 2012
End Date
August 1 2013
Last Update
March 21 2017
Active Locations (59)
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1
Research Site
Concord, New South Wales, Australia
2
Research Site
Kogarah, New South Wales, Australia
3
Research Site
Liverpool, New South Wales, Australia
4
Research Site
New Lambton Heights, New South Wales, Australia