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Study of Oral Fampridine-SR in Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Fampridine-SR
Placebo
Sponsored by
Acorda Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Walking Ability

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Have a confirmed diagnosis of multiple sclerosis Are able to walk with or without an assistive device Exclusion Criteria: Pregnancy, breastfeeding or females of childbearing potential not using adequate birth control Participating in other investigational drug trials A medical history or clinical findings that preclude entry into the study A medication history that precludes entry into the study Previously treated with 4-aminopyridine (4-AP)

Sites / Locations

  • University of Alabama
  • Barrow Neurology Clinic, St. Joseph's Hospital and Medical Center
  • USC, Keck School of Medicine
  • UC Davis
  • University of Colorado Health Sciences Center
  • Multiple Sclerosis Treatment Center
  • Shepard Center
  • University of Chicago
  • Indiana University MS Center
  • Maryland Center for MS
  • Wayne State University, Department of Neurology
  • The Schapiro Center for MS
  • Washington University SOM
  • Gimbel MS Center at Holy Name Hospital
  • University of Mexico, MIND Imaging Center
  • Maimonides Medical Center
  • Corinne Goldsmith Dickinson Center for MS
  • University of Rochester
  • SUNY - Stony Brook
  • Carolinas Healthcare System
  • Cleveland Clinical Foundation
  • Ohio State University MS Center
  • Oregon Health & Science University, MS Center of Oregon, UHS-42
  • Thomas Jefferson University Physicians
  • Allegheny General Hospital, Allegheny Neurological Associates
  • University of Texas - Houston
  • Neurological Research Center, Inc.
  • Fletcher Allen Health Care
  • MS Hub Medical Group
  • University of Washington, MS Research Center
  • Foothills Medical Center
  • University of British Columbia, Vancouver Coastal Health Research Institute
  • QEII Health Sciences Centre, Nova Scotia Rehabilitation Centre Site
  • Ottawa Hospital General Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo- sugar pill

Fampridine-SR

Arm Description

Placebo control

10 milligram (mg) tablet b.i.d.

Outcomes

Primary Outcome Measures

Timed Walk Responders (Patients Who Showed Consistent Improvement on the Timed-25 Foot Walk)
Patients who showed a faster walking speed for at least three of the four on-drug visits during the double-blind treatment period as compared to the maximum speed for any of the five off-drug visits.

Secondary Outcome Measures

Lower Extremity Manual Muscle Test; Ashworth Score for Spasticity

Full Information

First Posted
August 4, 2005
Last Updated
August 13, 2018
Sponsor
Acorda Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT00127530
Brief Title
Study of Oral Fampridine-SR in Multiple Sclerosis
Official Title
Double-Blind, Placebo-Controlled, 21-Week, Parallel Group Study to Evaluate Safety and Efficacy of Oral Fampridine-SR in Subjects With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acorda Therapeutics

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To assess the safety and efficacy of 10 milligram (mg) twice a day (b.i.d.) Fampridine-SR in patients diagnosed with multiple sclerosis (MS), in a double-blind, placebo-controlled, parallel group study.
Detailed Description
Multiple sclerosis (MS) is a disorder of the body's immune system that affects the central nervous system (CNS). Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. In people with MS, the fatty sheath that surrounds and insulates the nerve fibers (called "myelin") deteriorates, causing nerve impulses to be slowed or stopped. As a result, patients with MS may experience periods of muscle weakness and other symptoms such as numbness, loss of vision, loss of coordination, paralysis, spasticity, mental and physical fatigue and a decrease in the ability to think and/or remember. These periods of illness may come (exacerbations) and go (remissions). Fampridine-SR is an experimental drug that has been reported to possibly improve muscle strength and walking ability for some people with MS. This study will evaluate the effects and possible risks of taking Fampridine-SR in subjects with MS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Walking Ability

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo- sugar pill
Arm Type
Placebo Comparator
Arm Description
Placebo control
Arm Title
Fampridine-SR
Arm Type
Experimental
Arm Description
10 milligram (mg) tablet b.i.d.
Intervention Type
Drug
Intervention Name(s)
Fampridine-SR
Other Intervention Name(s)
Sustained release 4-aminopyridine, 4-AP
Intervention Description
Tablets, 10 mg, twice daily, 14 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
sugar pill, twice a day (b.i.d.)
Primary Outcome Measure Information:
Title
Timed Walk Responders (Patients Who Showed Consistent Improvement on the Timed-25 Foot Walk)
Description
Patients who showed a faster walking speed for at least three of the four on-drug visits during the double-blind treatment period as compared to the maximum speed for any of the five off-drug visits.
Time Frame
Days 14, 42, 70 and 98 of treatment, corresponding to the four on-drug visits during double-blind treatment period.
Secondary Outcome Measure Information:
Title
Lower Extremity Manual Muscle Test; Ashworth Score for Spasticity
Time Frame
Days 14, 42, 70, 98

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have a confirmed diagnosis of multiple sclerosis Are able to walk with or without an assistive device Exclusion Criteria: Pregnancy, breastfeeding or females of childbearing potential not using adequate birth control Participating in other investigational drug trials A medical history or clinical findings that preclude entry into the study A medication history that precludes entry into the study Previously treated with 4-aminopyridine (4-AP)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Blight, PhD
Organizational Affiliation
Acorda Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Barrow Neurology Clinic, St. Joseph's Hospital and Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
USC, Keck School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UC Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of Colorado Health Sciences Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Multiple Sclerosis Treatment Center
City
Derby
State/Province
Connecticut
ZIP/Postal Code
06418
Country
United States
Facility Name
Shepard Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Indiana University MS Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Maryland Center for MS
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Wayne State University, Department of Neurology
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
The Schapiro Center for MS
City
Golden Valley
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Washington University SOM
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Gimbel MS Center at Holy Name Hospital
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
University of Mexico, MIND Imaging Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Maimonides Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11220
Country
United States
Facility Name
Corinne Goldsmith Dickinson Center for MS
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
SUNY - Stony Brook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Carolinas Healthcare System
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Cleveland Clinical Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44095
Country
United States
Facility Name
Ohio State University MS Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Name
Oregon Health & Science University, MS Center of Oregon, UHS-42
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Thomas Jefferson University Physicians
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Allegheny General Hospital, Allegheny Neurological Associates
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
University of Texas - Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Neurological Research Center, Inc.
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
Facility Name
Fletcher Allen Health Care
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
MS Hub Medical Group
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
University of Washington, MS Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Foothills Medical Center
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
University of British Columbia, Vancouver Coastal Health Research Institute
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 2B5
Country
Canada
Facility Name
QEII Health Sciences Centre, Nova Scotia Rehabilitation Centre Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 4K4
Country
Canada
Facility Name
Ottawa Hospital General Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
19249634
Citation
Goodman AD, Brown TR, Krupp LB, Schapiro RT, Schwid SR, Cohen R, Marinucci LN, Blight AR; Fampridine MS-F203 Investigators. Sustained-release oral fampridine in multiple sclerosis: a randomised, double-blind, controlled trial. Lancet. 2009 Feb 28;373(9665):732-8. doi: 10.1016/S0140-6736(09)60442-6.
Results Reference
result

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Study of Oral Fampridine-SR in Multiple Sclerosis

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