Back to resultsOpen-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis Who Participated in the MS-F204 Trial
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Fampridine-SR
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring multiple sclerosis, MS, walking, leg strength, demyelination
Eligibility Criteria
Inclusion Criteria:
- Patient must have been previously enrolled in the Acorda Therapeutics MS-F204 study and received either Fampridine-SR or placebo
- Patient with clinically defined multiple sclerosis (the diagnostic criteria based on: McDonald WI, et al. Recommended Diagnostic Criteria for Multiple Sclerosis: Guidelines from the International Panel on the Diagnosis of Multiple Sclerosis. Annals of Neurology. 2001; 50: 121-127)
- Patient must be at least 18 years of age. Any patient who is now over the age of 70 must be in good overall health in the judgment of the investigator
- Patient must be of adequate cognitive function, as judged by the Investigator
- Patients who are women of childbearing potential must have a negative urine pregnancy test at the screening visit
Exclusion Criteria:
- Female patients who are either pregnant or breastfeeding.
- Women of childbearing potential who are not using a specified birth control method
- Patients discontinued prematurely from the MS-F204 study
- Patients with a history of seizures or with evidence of past, or possible epileptiform activity on an EEG
- Patient with either a clinically significant abnormal ECG or laboratory values at the MS-F204 EXT screening visit
- Patient with severe renal impairment
- Patient with angina, uncontrolled hypertension, clinically significant cardiac arrhythmias, or any other clinically significant cardiovascular abnormality, as judged by the Investigator
- Patient with a known allergy to pyridine-containing substances or any of the inactive ingredients of the Fampridine-SR tablet
- Patient who has received an investigational drug (other than Fampridine-SR or placebo under MS-F204 study) within 30 days of the MS-F204EXT screening visit or a patient who is scheduled to enroll in an investigational drug trial at any time during this study
- Patient who has a history of drug or alcohol abuse within the past year
Sites / Locations
- Barrow Neurology Clinic, St. Joseph's Hospital and Medical Center
- HOPE Research Institute
- Neurological Associates
- Alta Bates Summit Medical Center - Research and Education Institute
- USC, Keck School of Medicine Health Care Consultation Center
- UC Davis
- Yale University MS Center
- Shepherd Center
- University of Chicago
- Consultants in Neurology, Ltd.
- Indiana University MS Center
- Associates in Neurology, PSC
- Maryland Center for MS
- Lahey Clinic
- Wayne State University, Department of Neurology
- The Schapiro Center for MS
- Washington University School of Medicine
- Advanced Neurology Specialists
- UMDNJ
- Gimbel MS Center at Holy Name Hospital
- Jacobs Neurological Institute Buffalo General Hospital
- Corinne Goldsmith Dickinson Center for MS
- Columbia University Multiple Sclerosis Clinical Care Center
- University of Rochester
- SUNY Stony Brook
- CMC - Neuroscience & Spine Institute, Division of Neurology
- Raleigh Neurology Associates
- Wake Forest University, Dept of Neurology, M.S. Research
- The Center for Neurological Services
- Cleveland Clinic Foundation
- Ohio State University MS Center
- Oregon Health & Science University, MS Center of Oregon, UHS-42
- Thomas Jefferson University Physicians
- Neurological Research Center, Inc.
- Fletcher Allen Health Care
- MS Center at Evergreen
- CAMC Health Education & Research Institute
- Center for Neurological Disorders of Aurora, St. Luke's Medical Center
- Foothills Medical Center
- University of British Columbia, Vancouver Coastal Health Research Institute
- River Valley Health c/o Stan Cassidy Centre for Rehabilitation
- QEII Health Sciences Centre, Nova Scotia Rehabilitation Centre Site
Outcomes
Primary Outcome Measures
Summary of Treatment Emergent Adverse Events (TEAE).
All adverse events reported were treatment emergent. Therefore, events that had a date of onset, or worsening, on or after the start of the open-label drug and up to 14 days after the last dose (for non-serious events) or up to 30 days after the last dose (for SAEs) were summarized. Any abnormal clinically significant changes in physical examination, medical history, clinical laboratory testing, 12-lead ECG, and standard EEG testing were captured as adverse events.
Secondary Outcome Measures
Timed 25-Foot Walk (T25FW)
Subject Global Impression (SGI)
For the SGI, the potential responses to the effects of the investigational drug during the preceding week were 1=terrible, 2=unhappy, 3=mostly dissatisfied, 4=neutral/ mixed, 5=mostly satisfied, 6=pleased, and 7=delighted.
Clinician's Global Impression (CGI)
The potential responses were 1=very much improved, 2=much improved, 3=somewhat improved, 4=no change, 5=somewhat worse, 6=much worse, and 7=very much worse.
Expanded Disability Status Scale (EDSS)
The EDSS was used to grade patient disability on a scale from 0.0 (normal neurological exam) to 10.0 (death)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00649792
Brief Title
Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis Who Participated in the MS-F204 Trial
Official Title
Phase 3 Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis Who Participated in the MS-F204 Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
April 2011 (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
The purpose of the study is to evaluate the safety, tolerability and activity of Fampridine-SR when administered for up to 36 additional months in patients who previously participated in the MS-F204 study or until it becomes commercially available, whichever comes first.
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 MS patients over a long period of time.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
multiple sclerosis, MS, walking, leg strength, demyelination
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
214 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Fampridine-SR
Other Intervention Name(s)
4-aminopyridine
Intervention Description
Tablets, 10 mg, BID (twice daily)
Primary Outcome Measure Information:
Title
Summary of Treatment Emergent Adverse Events (TEAE).
Description
All adverse events reported were treatment emergent. Therefore, events that had a date of onset, or worsening, on or after the start of the open-label drug and up to 14 days after the last dose (for non-serious events) or up to 30 days after the last dose (for SAEs) were summarized. Any abnormal clinically significant changes in physical examination, medical history, clinical laboratory testing, 12-lead ECG, and standard EEG testing were captured as adverse events.
Time Frame
up to 40 months
Secondary Outcome Measure Information:
Title
Timed 25-Foot Walk (T25FW)
Time Frame
Week 2, 14, 26, continuing every 26 weeks until the Final Visit
Title
Subject Global Impression (SGI)
Description
For the SGI, the potential responses to the effects of the investigational drug during the preceding week were 1=terrible, 2=unhappy, 3=mostly dissatisfied, 4=neutral/ mixed, 5=mostly satisfied, 6=pleased, and 7=delighted.
Time Frame
Visit 1 and every clinic visit thereafter (other than the follow-up visit)
Title
Clinician's Global Impression (CGI)
Description
The potential responses were 1=very much improved, 2=much improved, 3=somewhat improved, 4=no change, 5=somewhat worse, 6=much worse, and 7=very much worse.
Time Frame
Visit 1 and every clinic visit thereafter
Title
Expanded Disability Status Scale (EDSS)
Description
The EDSS was used to grade patient disability on a scale from 0.0 (normal neurological exam) to 10.0 (death)
Time Frame
The Screening Visit, Visit 6, Final Visit or Early Termination Visit (if applicable)
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:
Patient must have been previously enrolled in the Acorda Therapeutics MS-F204 study and received either Fampridine-SR or placebo
Patient with clinically defined multiple sclerosis (the diagnostic criteria based on: McDonald WI, et al. Recommended Diagnostic Criteria for Multiple Sclerosis: Guidelines from the International Panel on the Diagnosis of Multiple Sclerosis. Annals of Neurology. 2001; 50: 121-127)
Patient must be at least 18 years of age. Any patient who is now over the age of 70 must be in good overall health in the judgment of the investigator
Patient must be of adequate cognitive function, as judged by the Investigator
Patients who are women of childbearing potential must have a negative urine pregnancy test at the screening visit
Exclusion Criteria:
Female patients who are either pregnant or breastfeeding.
Women of childbearing potential who are not using a specified birth control method
Patients discontinued prematurely from the MS-F204 study
Patients with a history of seizures or with evidence of past, or possible epileptiform activity on an EEG
Patient with either a clinically significant abnormal ECG or laboratory values at the MS-F204 EXT screening visit
Patient with severe renal impairment
Patient with angina, uncontrolled hypertension, clinically significant cardiac arrhythmias, or any other clinically significant cardiovascular abnormality, as judged by the Investigator
Patient with a known allergy to pyridine-containing substances or any of the inactive ingredients of the Fampridine-SR tablet
Patient who has received an investigational drug (other than Fampridine-SR or placebo under MS-F204 study) within 30 days of the MS-F204EXT screening visit or a patient who is scheduled to enroll in an investigational drug trial at any time during this study
Patient who has a history of drug or alcohol abuse within the past year
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bonnie Faust
Organizational Affiliation
Acorda Therapeutics
Official's Role
Study Director
Facility Information:
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
HOPE Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
Neurological Associates
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
Alta Bates Summit Medical Center - Research and Education Institute
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
USC, Keck School of Medicine Health Care Consultation Center
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
Yale University MS Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Shepherd 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
Consultants in Neurology, Ltd.
City
Northbrook
State/Province
Illinois
ZIP/Postal Code
60062
Country
United States
Facility Name
Indiana University MS Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Associates in Neurology, PSC
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Maryland Center for MS
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Lahey Clinic
City
Lexington
State/Province
Massachusetts
ZIP/Postal Code
02421
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 School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Advanced Neurology Specialists
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
UMDNJ
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
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
Jacobs Neurological Institute Buffalo General Hospital
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
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
Columbia University Multiple Sclerosis Clinical Care Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
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
CMC - Neuroscience & Spine Institute, Division of Neurology
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Raleigh Neurology Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Wake Forest University, Dept of Neurology, M.S. Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
The Center for Neurological Services
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
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
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 Center at Evergreen
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Facility Name
CAMC Health Education & Research Institute
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Facility Name
Center for Neurological Disorders of Aurora, St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
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
River Valley Health c/o Stan Cassidy Centre for Rehabilitation
City
Fredericton
State/Province
New Brunswick
ZIP/Postal Code
E3B 0C7
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
12. IPD Sharing Statement
Links:
URL
http://www.acorda.com/clinical.asp
Description
Click here for more information about Fampridine-SR clinical trials
Learn more about this trial
Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis Who Participated in the MS-F204 Trial
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