Multiple SclerosisPhase 3NCT00127530
Study of Oral Fampridine-SR in Multiple Sclerosis
A Phase 3 study testing Fampridine-SR in people with Multiple Sclerosis, run by Acorda Therapeutics at 34 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Fampridine-SR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 34 sitesin 2 countries
- Study dates
- May 2005to Sep 2006
- 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
- Have a confirmed diagnosis of multiple sclerosis
- Are able to walk with or without an assistive device
Who cannot join
- 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)
Trial locations and contacts
34 sites in 2 countries.
34 sites in 2 countries
United States30 sites
University of Mexico, MIND Imaging Center
Albuquerque, New Mexico, 87131
Shepard Center
Atlanta, Georgia, 30309
Maryland Center for MS
Baltimore, Maryland, 21201
Neurological Research Center, Inc.
Bennington, Vermont, 05201
University of Alabama
Birmingham, Alabama, 35233
Maimonides Medical Center
Brooklyn, New York, 11220
Fletcher Allen Health Care
Burlington, Vermont, 05401
Carolinas Healthcare System
Charlotte, North Carolina, 28207
University of Chicago
Chicago, Illinois, 60637
Cleveland Clinical Foundation
Cleveland, Ohio, 44095
Ohio State University MS Center
Columbus, Ohio, 43221
University of Colorado Health Sciences Center
Denver, Colorado, 80262
Multiple Sclerosis Treatment Center
Derby, Connecticut, 06418
Wayne State University, Department of Neurology
Detroit, Michigan, 48201
The Schapiro Center for MS
Golden Valley, Minnesota, 55422
University of Texas - Houston
Houston, Texas, 77030
Indiana University MS Center
Indianapolis, Indiana, 46202
USC, Keck School of Medicine
Los Angeles, California, 90033
Corinne Goldsmith Dickinson Center for MS
New York, New York, 10029
Thomas Jefferson University Physicians
Philadelphia, Pennsylvania, 19107
Barrow Neurology Clinic, St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
Allegheny General Hospital, Allegheny Neurological Associates
Pittsburgh, Pennsylvania, 15212
Oregon Health & Science University, MS Center of Oregon, UHS-42
Portland, Oregon, 97239
University of Rochester
Rochester, New York, 14642
UC Davis
Sacramento, California, 95817
MS Hub Medical Group
Seattle, Washington, 98101
University of Washington, MS Research Center
Seattle, Washington, 98195
Washington University SOM
St Louis, Missouri, 63110
SUNY - Stony Brook
Stony Brook, New York, 11794
Gimbel MS Center at Holy Name Hospital
Teaneck, New Jersey, 07666
Canada4 sites
Foothills Medical Center
Calgary, Alberta, T2N 2T9
QEII Health Sciences Centre, Nova Scotia Rehabilitation Centre Site
Halifax, Nova Scotia, B3H 4K4
Ottawa Hospital General Campus
Ottawa, Ontario, K1H 8L6
University of British Columbia, Vancouver Coastal Health Research Institute
Vancouver, British Columbia, V6T 2B5
About this study
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
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Fampridine-SR, Placebo
- Keywords
- Walking Ability
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fampridine-SRDrug
Also called Sustained release 4-aminopyridine, 4-AP
Tablets, 10 mg, twice daily, 14 weeks
PlaceboDrug
sugar pill, twice a day (b.i.d.)
| Study group | Role | What they receive |
|---|---|---|
| Placebo- sugar pill | Placebo comparator | Placebo control Receives: Drug: Placebo |
| Fampridine-SR | Experimental | 10 milligram (mg) tablet b.i.d. Receives: Drug: Fampridine-SR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Days 14, 42, 70 and 98 of treatment, corresponding to the four on-drug visits during double-blind treatment period.
Secondary outcomes (1)
Lower Extremity Manual Muscle Test; Ashworth Score for Spasticity
Measured: Days 14, 42, 70, 98
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2005 (estimated)
- Study startMay 2005
- Primary completionJun 2006
- Study completionSep 2006
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acorda Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Blight, PhD, Study director, Acorda Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00127530
- Sponsor's protocol ID
- MS-F203
- Status last verified
- Aug 2018
- First submitted
- 4 Aug 2005
- Last updated
- 11 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 19249634
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00127530
- Acronym / sponsor ID
- MS-F203
- Conditions
- Multiple Sclerosis
- Keywords
- Walking Ability
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Acorda TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 8 Aug 2005 (estimated)
- Results
- Posted 6 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo- sugar pill | Placebo comparator | Drug: PlaceboPlacebo control |
| Fampridine-SR | Experimental | Drug: Fampridine-SR10 milligram (mg) tablet b.i.d. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have a confirmed diagnosis of multiple sclerosis
- Are able to walk with or without an assistive device
Key exclusion criteria (5 listed)
- 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)
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-SRAlso: Sustained release 4-aminopyridine, 4-APTablets, 10 mg, twice daily, 14 weeks | Drug | Fampridine-SR |
| Placebosugar pill, twice a day (b.i.d.) | Drug | Placebo- sugar pill |
Primary outcome
Timed Walk Responders (Patients Who Showed Consistent Improvement on the Timed-25 Foot Walk)
Time frame: Days 14, 42, 70 and 98 of treatment, corresponding to the four on-drug visits during double-blind treatment period.
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.
1 secondary outcome
Lower Extremity Manual Muscle Test; Ashworth Score for Spasticity
Time frame: Days 14, 42, 70, 98
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19249634Goodman 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.
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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, PhD study director
Acorda Therapeutics
34 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 Multiple Sclerosis, run by Acorda Therapeutics at 34 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 2 inclusion and 5 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 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 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 6 May 2011). 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?
Timed Walk Responders (Patients Who Showed Consistent Improvement on the Timed-25 Foot Walk) (time frame: Days 14, 42, 70 and 98 of treatment, corresponding to the four on-drug visits during double-blind treatment period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00127530, which also lists 1 linked publication.
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 11 Sep 2018; AzTrials last refreshed its copy on 7 Nov 2026.