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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01917019
Other study ID # 218MS304
Secondary ID
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
Health authority
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.

Study Design


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)
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