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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01917019
• Date of registration: 02/08/2013
• Prospective Registration: No
• Primary sponsor: Biogen
• Public title: A Safety and Efficacy Study of Oral Prolonged-Release Fampridine (BIIB041) in Japanese Participants With Multiple Sclerosis MOTION - JAPAN
• Scientific title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of Oral Prolonged-Release Fampridine (BIIB041) in Japanese Subjects With Multiple Sclerosis Followed by an Open-Label Safety Extension
• Date of first enrolment: August 2013
• Target sample size: 101
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01917019
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Japan

Contacts

• Name: Medical Director
• Affiliation: Biogen

Key inclusion & exclusion criteria

Key Inclusion Criteria:

Part A

To be eligible to participate in Part A, candidates must meet the following eligibility
criteria at screening or at the timepoint specified in the individual eligibility criterion
listed (potential subjects who fail screening may be rescreened 1 time):

1. Must have a diagnosis of primary-progressive, secondary progressive, progressive
relapsing, or relapsing-remitting MS as defined by the revised McDonald Committee
criteria ([Lublin and Reingold 1996; McDonald 2001; Polman 2005]) of at least 2 months
duration.

2. Must be able to complete the T25FW with or without a walking aid in 8 to 45 seconds at
the screening visit.

Part B

To be eligible to participate in Part B, candidates must meet the following criteria at the
Week 21 visit in Part A, which is the first visit for Part B:

1. Completed all visits in Part A of the study.

Part C

To be eligible to participate in Part C, candidates must meet the following criteria at the
Week 52 visit in Part B, which is the first visit for Part C:

1. Completed all visits in Part B of the study.

Key Exclusion Criteria:

1. Known allergy to pyridine-containing substances, or any of the inactive ingredients of
the prolonged-release fampridine tablet

2. Any prior history of seizures, epilepsy, or other convulsive disorder, with the
exception of febrile seizures in childhood, or prior history of epileptiform activity
on electroencephalogram.

3. Any form of renal impairment as defined by a creatinine clearance (CrCl) of <80 mL/min
(estimated by the central laboratory).

4. Known history of cardiac arrhythmia or cardiac conduction disorders requiring medical
or surgical intervention, or any clinically significant ECG abnormality (as determined
by the Investigator) at the screening visit or Day 1.

5. Any prior treatment with fampridine (4 AP) or 3,4 diaminopyridine in any formulation.

6. Treatment with an investigational drug or approved therapy for investigational use
within 30 days (or 5 half lives, whichever is longer) prior to the screening visit.

7. Participation in an investigational study (with the exception of observational
studies) within 30 days prior to the screening visit or plans to enroll in another
interventional investigational study at any time during this study.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis, Remittent Progressive

Secondary Progressive Multiple Sclerosis

Multiple Sclerosis, Primary Progressive

Relapsing-Remitting Multiple Sclerosis

Multiple Sclerosis

Intervention(s)

Drug: Placebo

Drug: BIIB041 (fampridine)

Primary Outcome(s)

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)]

Secondary Outcome(s)

Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: Part A (Up to 21 Weeks)]

Secondary ID(s)

218MS304

Source(s) of Monetary Support

Please refer to primary and secondary sponsors