This is a multicenter study conducted in 3 parts. Part A is a double-blind placebo-controlled parallel-group period, and Part B and C are open-label extension periods. The primary objective of the double-blind study (Part A) is to assess the effect of Prolonged-Release Fampridine treatment on walking speed as measured by the T25FW (timed 25 foot walk) in Japanese participants with Multiple Sclerosis. The secondary objective of the double-blind portion of the study is to evaluate the safety and tolerability of prolonged-release Fampridine in this study population. The primary objective of the open-label extension study (Part B) is to evaluate the long-term safety profile of prolonged-release Fampridine. The primary objective of the additional open-label extension (Part C) is to provide participants who complete the study with continued access to prolonged-release fampridine until marketed drug can be used at the applicable site or until sponsor decision to discontinue the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
101
matching placebo tablets
fampridine prolonged-release tablets
Research Site
Bunkyō City, Japan
Research Site
Chiba, Japan
Research Site
Fuchū, Japan
Research Site
Fukuoka, Japan
Research Site
Kawagoe-shi, Japan
Research Site
Kodaira-shi, Japan
Research Site
Kyoto, Japan
Research Site
Morioka, Japan
Research Site
Niigata, Japan
Research Site
Obihiro, Japan
...and 9 more locations
The proportion of participants who show a consistent improvement in walking speed
Time frame: Part A (Up to 21 Weeks)
Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Part B (54 Weeks)
Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Part A (Up to 21 Weeks)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.