Status:
COMPLETED
Efficacy and Safety Study of Prolonged-Release Fampridine in Participants With Multiple Sclerosis
Lead Sponsor:
Biogen
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The primary objective is to determine whether prolonged-release fampridine (10 mg twice daily) has a clinically meaningful effect on participant-reported walking ability over a 24-week study period. ...
Eligibility Criteria
Inclusion
- Key
- Must have a diagnosis of primary-progressive, secondary-progressive, progressive-relapsing, or relapsing-remitting MS per revised McDonald Committee criteria \[McDonald 2001; Polman 2005\] as defined by Lublin and Reingold \[Lublin and Reingold 1996\] of at least 3 months duration
- Must have an Expanded Disability Status Scale (EDSS) score of 4 to 7, inclusive
- Must have walking impairment, as deemed by the Investigator
- Key
Exclusion
- History of human immunodeficiency virus (HIV)
- Presence of acute or chronic hepatitis. Subjects who have evidence of prior hepatitis infection that has been serologically confirmed as resolved are not excluded from study participation
- Known allergy to fampridine, pyridine-containing substances, or any of the inactive ingredients in the prolonged-release fampridine tablet
- Creatinine clearance (CrCl) of \<80 mL/min
- History of malignant disease
- Presence of pulmonary disease
- A body mass index (BMI) ≥40 (BMI formula: BMI = mass \[kg\]/\[height(m)\]2)
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
646 Patients enrolled
Trial Details
Trial ID
NCT02219932
Start Date
September 1 2014
End Date
February 1 2016
Last Update
March 27 2017
Active Locations (87)
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1
Research site
Cullman, Alabama, United States, 35058
2
Research site
Phoenix, Arizona, United States, 85013
3
Research site
San Diego, California, United States, 92108
4
Research site
Bradenton, Florida, United States, 34205