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A Safety and Efficacy Study of Oral Prolonged-Release Fampridine (BIIB041) in Japanese Participants With Multiple Sclerosis

NCT01917019 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2017-03-21

No results posted yet for this study

Summary

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.

Conditions

  • Multiple Sclerosis, Remittent Progressive
  • Multiple Sclerosis, Primary Progressive
  • Relapsing-Remitting Multiple Sclerosis
  • Secondary Progressive Multiple Sclerosis
  • Multiple Sclerosis

Interventions

DRUG

Placebo

matching placebo tablets

DRUG

BIIB041 (fampridine)

fampridine prolonged-release tablets

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2015-10-31
Completion
2017-03-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01917019 on ClinicalTrials.gov