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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biogen
ClinicalTrials.gov Identifier:
NCT01917019
First received: August 2, 2013
Last updated: June 26, 2015
Last verified: June 2015
  Purpose

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.


Condition Intervention Phase
Multiple Sclerosis, Remittent Progressive
Multiple Sclerosis, Primary Progressive
Relapsing-Remitting Multiple Sclerosis
Secondary Progressive Multiple Sclerosis
Multiple Sclerosis
Drug: Placebo
Drug: BIIB041 (fampridine)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Biogen:

Primary Outcome Measures:
  • The proportion of participants who show a consistent improvement in walking speed [ Time Frame: Part A (Up to 21 Weeks) ] [ Designated as safety issue: No ]
  • Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Part B (54 Weeks) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Part A (Up to 21 Weeks) ] [ Designated as safety issue: Yes ]

Enrollment: 101
Study Start Date: August 2013
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Part A Placebo
Part A: All participants will receive placebo orally twice daily for the first 2 weeks and then be randomized to receive prolonged-release fampridine 10 mg or matching placebo tablets orally twice daily for up to 14 weeks.
Drug: Placebo
matching placebo tablets
Experimental: Part A prolonged-release fampridine
Part A: All participants will receive placebo orally twice daily for the first 2 weeks and then be randomized to receive prolonged-release fampridine 10 mg or matching placebo tablets orally twice daily for up to 14 weeks.
Drug: BIIB041 (fampridine)
fampridine prolonged-release tablets
Other Names:
  • Fampyra
  • prolonged-release fampridine
  • dalfampridine
  • Ampyra
Experimental: Part B prolonged-release fampridine
Part B: Eligible participants will receive open label treatment with prolonged-release fampridine 10mg orally twice daily for up to 52 weeks.
Drug: BIIB041 (fampridine)
fampridine prolonged-release tablets
Other Names:
  • Fampyra
  • prolonged-release fampridine
  • dalfampridine
  • Ampyra
Experimental: Part C prolonged-release fampridine
Part C: Eligible participants will receive open label treatment with prolonged-release fampridine 10mg orally twice daily until marketed product is available.
Drug: BIIB041 (fampridine)
fampridine prolonged-release tablets
Other Names:
  • Fampyra
  • prolonged-release fampridine
  • dalfampridine
  • Ampyra

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01917019

Locations
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
Nagoya, 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, Japan
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen
  More Information

No publications provided

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01917019     History of Changes
Other Study ID Numbers: 218MS304
Study First Received: August 2, 2013
Last Updated: June 26, 2015
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency (PMDA)

Keywords provided by Biogen:
Japan

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
4-Aminopyridine
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Potassium Channel Blockers
Therapeutic Uses

ClinicalTrials.gov processed this record on June 30, 2015