Spinal Cord InjuryPhase 3NCT00041717
Safety and Efficacy of Oral Fampridine-SR for the Treatment of Spasticity Resulting From Spinal Cord Injury
A Phase 3 study testing Fampridine-SR in people with Spinal Cord Injury and Muscle Spasticity, run by Acorda Therapeutics at 45 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injury, Muscle Spasticity
- What is being tested?
- Fampridine-SR
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 213 participants
- Where
- 45 sitesin 2 countries
- Study dates
- Jul 2002to May 2004
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
45 sites in 2 countries.
45 sites in 2 countries
United States37 sites
Good Shepherd Rehabilitation
Allentown, Pennsylvania, 18103
Shepherd Spinal Center
Atlanta, Georgia, 30309
Lakeshore Rehabilitation Hospital
Birmingham, Alabama, 35209
Clinical Research Services
Bismarck, North Dakota, 58501
Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02114
HEALTHSOUTH Braintree Rehabilitation Hospital
Braintree, Massachusetts, 02185
UNC Chapel Hill
Chapel Hill, North Carolina, 27599
CAMC Health Education & Research Institute
Charleston, West Virginia, 25304
Rehabilitation Institute of Chicago
Chicago, Illinois, 60611
Drake Center
Cincinnati, Ohio, 45216
Cleveland VAMC
Cleveland, Ohio, 44106
Mary Free Bed Hospital & Rehabilitation Center
Grand Rapids, Michigan, 49503
East Carolina University
Greenville, North Carolina, 27858
Hampton VA Hospital
Hampton, Virginia, 23667
Baptist Medical Center
Little Rock, Arkansas, 72205
Bryn Mawr Rehabilitation Hospital
Malvern, Pennsylvania, 19355
Miami Center to Cure Paralysis at the Univ. of Miami School of Medicine
Miami, Florida, 33136
Montana Neuroscience
Missoula, Montana, 59802
Advocate Christ Medical Center-Dept. of Physical Medicine & Rehabilitation-EMG
Oak Lawn, Illinois, 60453
VA Palo Alto Health Care System
Palo Alto, California, 94304
Neuro-Therapeutics, Inc
Pasadena, California, 91005
Barrow Neurological Institute
Phoenix, Arizona, 85013
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
HEALTHSOUTH Harmarville Rehabilitation Hospital
Pittsburgh, Pennsylvania, 15238
Richmond VA Medical Center (Hunter Holmes McGuire)
Richmond, Virginia, 23249
Mayo Clinic
Rochester, Minnesota, 55905
Rehabilitation Services University of Utah Hospitals and Clinics
Salt Lake City, Utah, 84132
Northeastern Rehabilitation Associates
Scranton, Pennsylvania, 18501
Springfield Clinic-Neuroscience Institute
Springfield, Illinois, 62702
Washington University School of Medicine, Div. of Rehab/Neurology
St Louis, Missouri, 63110
Rehabilitation Hospital
Sunrise, Florida, 33351
National Rehabilitation Hospital
Washington D.C., District of Columbia, 20010
Kessler Institute of Rehabilitation
West Orange, New Jersey, 07052
The Burke Rehabilitation Hospital
White Plains, New York, 10605
Neurology Associates, P.A.
Wilmington, Delaware, 19806
Wake Forest University
Winston-Salem, North Carolina, 27157
HEALTHSOUTH New England Rehabilitation Hospital
Woburn, Massachusetts, 01801
Canada8 sites
Foothills Provincial General Hospital
Calgary, Alberta, T2N 2T9
Glenrose Rehabilitation Hospital
Edmonton, Alberta, T5G 0B7
Stan Cassidy Centre for Rehabilitation
Fredericton, New Brunswick, E3B 4R3
QEII HSC-Nova Scotia Rehabilitation Centre
Halifax, Nova Scotia, B3M 4K4
Parkwood Hospital Site, St. Joseph's Health Care
London, Ontario, N6C 5J1
The Rehabilitation Centre
Ottawa, Ontario, K1H 8M2
Toronto Rehabilitation Institute, Lyndhurst Centre
Toronto, Ontario, M5G 3V9
G.F. Strong Rehabilitation Centre
Vancouver, British Columbia, V5Z 2G9
About this study
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
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.
- Conditions
- Spinal Cord Injury, Muscle Spasticity
- Being tested
- Fampridine-SR, Placebo
- Keywords
- spinal cord injury, muscle spasticity
- Medical subject headings
- Spinal Cord Injuries, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fampridine-SRDrug
25mg bid (twice daily)
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| fampridine-SR 50mg/day | Active comparator | Not described Receives: Drug: Fampridine-SR |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98
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.
Measured: Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2002 (estimated)
- Study startJul 2002
- Primary completionFeb 2004
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acorda Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Blight, Study director, Acorda Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00041717
- Sponsor's protocol ID
- SCI-F301
- Status last verified
- Apr 2013
- First submitted
- 12 Jul 2002
- Last updated
- 14 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00041717
- Acronym / sponsor ID
- SCI-F301
- Conditions
- Spinal Cord Injury, Muscle Spasticity
- Keywords
- spinal cord injury, muscle spasticity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Acorda TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jul 2002
- Primary completion
- Feb 2004 (actual)
- Study completion
- May 2004 (actual)
- First posted
- 16 Jul 2002 (estimated)
- Results
- Posted 31 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fampridine-SR 50mg/day | Active comparator | Drug: Fampridine-SR |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- Pregnancy
- History of seizures
- Existing or history of frequent Urinary Tract Infections
- History of drug or alcohol abuse
- Allergy to pyridine-containing substances
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fampridine-SR25mg bid (twice daily) | Drug | fampridine-SR 50mg/day |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity
Time frame: Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98
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
Time frame: Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Blight study director
Acorda Therapeutics
45 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fampridine-SR in people with Spinal Cord Injury and Muscle Spasticity, run by Acorda Therapeutics at 45 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity (time frame: Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2020.