Efficacy and Safety Study of Prolonged-Release Fampridine in Participants With Multiple Sclerosis
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Neurology, Multiple Sclerosis |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | September 2014 |
| End Date: | February 2016 |
A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Long-Term Efficacy and Safety of Prolonged Release Fampridine (BIIB041) 10 mg, Administered Twice Daily in Subjects With Multiple Sclerosis
The primary objective is to determine whether prolonged-release fampridine (10 mg twice
daily) has a clinically meaningful effect on patient-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.
daily) has a clinically meaningful effect on patient-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.
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.
We found this trial at
18
sites
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