Overview

Efficacy and Safety Study of Prolonged-Release Fampridine in Participants With Multiple Sclerosis

Status:
Completed
Trial end date:
2016-02-01
Target enrollment:
0
Participant gender:
All
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. The secondary objectives are: to determine whether prolonged-release fampridine 10 mg taken twice daily (BID) has a clinically meaningful effect on dynamic and static balance, physical impact of multiple sclerosis (MS), and upper extremity function over a 24-week study period; to evaluate criteria for early assessment of response to fampridine that can predict clinically meaningful benefits in walking ability and balance; to assess the safety and tolerability of prolonged-release fampridine 10 mg twice daily over a 24-week treatment period.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Biogen
Treatments:
4-Aminopyridine
Criteria
Key Inclusion Criteria:

- 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 Criteria:

- 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.