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Safety and Efficacy of Oral Fampridine-SR for the Treatment of Spasticity Resulting From Spinal Cord Injury

Primary Purpose

Spinal Cord Injury, Muscle Spasticity

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 Spinal Cord Injury focused on measuring spinal cord injury, muscle spasticity

Eligibility Criteria

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

Inclusion Criteria: Incomplete traumatic Spinal Cord Injury (at least 18 months prior and stable for 6 months) Moderate to severe lower-limb spasticity Able to give informed consent and willing to comply with protocol Exclusion Criteria: Pregnancy History of seizures Existing or history of frequent Urinary Tract Infections History of drug or alcohol abuse Allergy to pyridine-containing substances Received a botox injection 4 months prior to study Received an investigational drug within 30 days Previously treated with 4-aminopyridine (4-AP) Not on stable medication dosing in 3 weeks prior to study Abnormal ECG or laboratory value at screening

Sites / Locations

  • Lakeshore Rehabilitation Hospital
  • Barrow Neurological Institute
  • Baptist Medical Center
  • VA Palo Alto Health Care System
  • Neuro-Therapeutics, Inc
  • Neurology Associates, P.A.
  • National Rehabilitation Hospital
  • Miami Center to Cure Paralysis at the Univ. of Miami School of Medicine
  • Rehabilitation Hospital
  • Shepherd Spinal Center
  • Rehabilitation Institute of Chicago
  • Advocate Christ Medical Center-Dept. of Physical Medicine & Rehabilitation-EMG
  • Springfield Clinic-Neuroscience Institute
  • Spaulding Rehabilitation Hospital
  • HEALTHSOUTH Braintree Rehabilitation Hospital
  • HEALTHSOUTH New England Rehabilitation Hospital
  • Mary Free Bed Hospital & Rehabilitation Center
  • Mayo Clinic
  • Washington University School of Medicine, Div. of Rehab/Neurology
  • Montana Neuroscience
  • Kessler Institute of Rehabilitation
  • The Burke Rehabilitation Hospital
  • UNC Chapel Hill
  • East Carolina University
  • Wake Forest University
  • Clinical Research Services
  • Drake Center
  • Cleveland VAMC
  • Good Shepherd Rehabilitation
  • Bryn Mawr Rehabilitation Hospital
  • University of Pittsburgh
  • HEALTHSOUTH Harmarville Rehabilitation Hospital
  • Northeastern Rehabilitation Associates
  • Rehabilitation Services University of Utah Hospitals and Clinics
  • Hampton VA Hospital
  • Richmond VA Medical Center (Hunter Holmes McGuire)
  • CAMC Health Education & Research Institute
  • Foothills Provincial General Hospital
  • Glenrose Rehabilitation Hospital
  • G.F. Strong Rehabilitation Centre
  • Stan Cassidy Centre for Rehabilitation
  • QEII HSC-Nova Scotia Rehabilitation Centre
  • Parkwood Hospital Site, St. Joseph's Health Care
  • The Rehabilitation Centre
  • Toronto Rehabilitation Institute, Lyndhurst Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

fampridine-SR 50mg/day

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity
The Ashworth Score is the average rating (based on a scale of 1 to 5) of four lower extremity muscle groups; left and right knee flexors and extensors (hamstrings and quadriceps muscles). A higher Ashworth Score indicates a greater degree of abnormal muscle tone (spasticity) and a negative change in score indicates improvement.
Double-blind Change From Baseline in Subject's Global Impression (SGI) of Treatment
This questionnaire asked the patient to evaluate the effects of investigational drug on his/her quality of life during the preceding week using a 7-point scale (from 1=terrible to 7=delighted). A positive change score in SGI indicates improved outcome.

Secondary Outcome Measures

Full Information

First Posted
July 12, 2002
Last Updated
January 6, 2020
Sponsor
Acorda Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT00041717
Brief Title
Safety and Efficacy of Oral Fampridine-SR for the Treatment of Spasticity Resulting From Spinal Cord Injury
Official Title
Double-Blind, Placebo-Controlled, 12-Week Parallel Group Study to Evaluate Safety and Efficacy of Oral Fampridine-SR in Subjects With Moderate to Severe Spasticity Resulting From Chronic, Incomplete Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
February 2004 (Actual)
Study Completion Date
May 2004 (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
Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. In people with spinal cord injury, some fibers may be destroyed at the site of injury, while others remain connected but do not work correctly to carry electrical impulses. As a result, subjects with an incomplete spinal cord injury may have spasticity which is muscle spasms or muscle stiffness that makes movement difficult. Fampridine-SR is an experimental drug that increases the ability of the nerve to conduct electrical impulses. This study will examine the effects of Fampridine-SR on moderate to severe lower-limb spasticity, as well as the effects on bodily functions such as bladder control, bowel function and sexual function. The study will also examine the possible risks of taking Fampridine-SR.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Muscle Spasticity
Keywords
spinal cord injury, muscle spasticity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
213 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fampridine-SR 50mg/day
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Fampridine-SR
Intervention Description
25mg bid (twice daily)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity
Description
The Ashworth Score is the average rating (based on a scale of 1 to 5) of four lower extremity muscle groups; left and right knee flexors and extensors (hamstrings and quadriceps muscles). A higher Ashworth Score indicates a greater degree of abnormal muscle tone (spasticity) and a negative change in score indicates improvement.
Time Frame
Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98
Title
Double-blind Change From Baseline in Subject's Global Impression (SGI) of Treatment
Description
This questionnaire asked the patient to evaluate the effects of investigational drug on his/her quality of life during the preceding week using a 7-point scale (from 1=terrible to 7=delighted). A positive change score in SGI indicates improved outcome.
Time Frame
Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98

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: Incomplete traumatic Spinal Cord Injury (at least 18 months prior and stable for 6 months) Moderate to severe lower-limb spasticity Able to give informed consent and willing to comply with protocol Exclusion Criteria: Pregnancy History of seizures Existing or history of frequent Urinary Tract Infections History of drug or alcohol abuse Allergy to pyridine-containing substances Received a botox injection 4 months prior to study Received an investigational drug within 30 days Previously treated with 4-aminopyridine (4-AP) Not on stable medication dosing in 3 weeks prior to study Abnormal ECG or laboratory value at screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Blight
Organizational Affiliation
Acorda Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Lakeshore Rehabilitation Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Barrow Neurological Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Baptist Medical Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
VA Palo Alto Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Neuro-Therapeutics, Inc
City
Pasadena
State/Province
California
ZIP/Postal Code
91005
Country
United States
Facility Name
Neurology Associates, P.A.
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19806
Country
United States
Facility Name
National Rehabilitation Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Miami Center to Cure Paralysis at the Univ. of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Rehabilitation Hospital
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Facility Name
Shepherd Spinal Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Rehabilitation Institute of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Advocate Christ Medical Center-Dept. of Physical Medicine & Rehabilitation-EMG
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Springfield Clinic-Neuroscience Institute
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Spaulding Rehabilitation Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
HEALTHSOUTH Braintree Rehabilitation Hospital
City
Braintree
State/Province
Massachusetts
ZIP/Postal Code
02185
Country
United States
Facility Name
HEALTHSOUTH New England Rehabilitation Hospital
City
Woburn
State/Province
Massachusetts
ZIP/Postal Code
01801
Country
United States
Facility Name
Mary Free Bed Hospital & Rehabilitation Center
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University School of Medicine, Div. of Rehab/Neurology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Montana Neuroscience
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
Kessler Institute of Rehabilitation
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
Facility Name
The Burke Rehabilitation Hospital
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States
Facility Name
UNC Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27858
Country
United States
Facility Name
Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Clinical Research Services
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Drake Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45216
Country
United States
Facility Name
Cleveland VAMC
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Good Shepherd Rehabilitation
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Bryn Mawr Rehabilitation Hospital
City
Malvern
State/Province
Pennsylvania
ZIP/Postal Code
19355
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
HEALTHSOUTH Harmarville Rehabilitation Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15238
Country
United States
Facility Name
Northeastern Rehabilitation Associates
City
Scranton
State/Province
Pennsylvania
ZIP/Postal Code
18501
Country
United States
Facility Name
Rehabilitation Services University of Utah Hospitals and Clinics
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Hampton VA Hospital
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23667
Country
United States
Facility Name
Richmond VA Medical Center (Hunter Holmes McGuire)
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
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
Foothills Provincial General Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
Glenrose Rehabilitation Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5G 0B7
Country
Canada
Facility Name
G.F. Strong Rehabilitation Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 2G9
Country
Canada
Facility Name
Stan Cassidy Centre for Rehabilitation
City
Fredericton
State/Province
New Brunswick
ZIP/Postal Code
E3B 4R3
Country
Canada
Facility Name
QEII HSC-Nova Scotia Rehabilitation Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3M 4K4
Country
Canada
Facility Name
Parkwood Hospital Site, St. Joseph's Health Care
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 5J1
Country
Canada
Facility Name
The Rehabilitation Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8M2
Country
Canada
Facility Name
Toronto Rehabilitation Institute, Lyndhurst Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 3V9
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://www.acorda.com
Description
Related Info

Learn more about this trial

Safety and Efficacy of Oral Fampridine-SR for the Treatment of Spasticity Resulting From Spinal Cord Injury

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