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

Multiple Sclerosis Clinical Trial

— MOTION - JAPAN  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01917019
• Other study ID #: 218MS304
• Status: Completed
• Phase: Phase 3
• First received: August 2, 2013
• Last updated: March 17, 2017
• Start date: August 2013
• Est. completion date: March 2017

Study information

• Verified date: March 2017
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: March 2017
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Placebo
matching placebo tablets
• BIIB041 (fampridine)
fampridine prolonged-release tablets

Locations

Country	Name	City	State
Japan	Research Site	Bunkyo-ku
Japan	Research Site	Chiba-shi
Japan	Research Site	Fuchu
Japan	Research Site	Fukuoka-shi
Japan	Research Site	Kawagoe-shi
Japan	Research Site	Kodaira-shi
Japan	Research Site	Kyoto-shi
Japan	Research Site	Morioka
Japan	Research Site	Niigata
Japan	Research Site	Obihiro
Japan	Research Site	Osaka
Japan	Research Site	Ota-ku
Japan	Research Site	Sapporo-shi
Japan	Research Site	Sendai
Japan	Research Site	Shinjuku-ku
Japan	Research Site	Suita-shi
Japan	Research Site	Toon-shi
Japan	Research Site	Ube-shi
Japan	Research Site	Yachiyo-shi

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of participants who show a consistent improvement in walking speed		Part A (Up to 21 Weeks)
Primary	Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)		Part B (54 Weeks)
Secondary	Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)		Part A (Up to 21 Weeks)