Multiple SclerosisPhase 3NCT00483652
Study of Fampridine-SR Tablets in Multiple Sclerosis Patients
A Phase 3 study testing Fampridine-SR in people with Multiple Sclerosis, run by Acorda Therapeutics at 40 sites in 2 countries.
Trial summary
The purpose of the study is to show that individuals treated with Fampridine-SR tablets are significantly more likely to have consistent improvements in their walking than those treated with placebo tablets. 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
- 240 participants
- Where
- 40 sitesin 2 countries
- Study dates
- May 2007to May 2008
- 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
- Patient with clinically defined multiple sclerosis
- All patients must be able to complete two trials of a timed 25 foot walk
Who cannot join
- Female patients who are either pregnant or breastfeeding.
Trial locations and contacts
40 sites in 2 countries.
40 sites in 2 countries
United States36 sites
Shepherd Center
Atlanta, Georgia, 30309
Maryland Center for MS
Baltimore, Maryland, 21201
Neurological Research Center, Inc.
Bennington, Vermont, 05201
Alta Bates Summit Medical Center - Research and Education Institute
Berkeley, California, 94705
The Center for Neurological Services
Bismarck, North Dakota, 58501
Jacobs Neurological Institute Buffalo General Hospital
Buffalo, New York, 14203
Fletcher Allen Health Care
Burlington, Vermont, 05401
CAMC Health Education & Research Institute
Charleston, West Virginia, 25304
CMC - Neuroscience & Spine Institute, Division of Neurology
Charlotte, North Carolina, 28207
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Ohio State University MS Center
Columbus, Ohio, 43221
Neurological Associates
Fayetteville, Arkansas, 72703
The Schapiro Center for MS
Golden Valley, Minnesota, 55422
Advanced Neurology Specialists
Great Falls, Montana, 59405
Indiana University MS Center
Indianapolis, Indiana, 46202
MS Center at Evergreen
Kirkland, Washington, 98034
Associates in Neurology, PSC
Lexington, Kentucky, 40503
Lahey Clinic
Lexington, Massachusetts, 02421
USC, Keck School of Medicine Health Care Consultation Center
Los Angeles, California, 90033
Center for Neurological Disorders of Aurora, St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Yale University MS Center
New Haven, Connecticut, 06510
Corinne Goldsmith Dickinson Center for MS
New York, New York, 10029
Columbia University Multiple Sclerosis Clinical Care Center
New York, New York, 10032
UMDNJ
Newark, New Jersey, 07103
Consultants in Neurology, Ltd.
Northbrook, Illinois, 60062
Thomas Jefferson University Physicians
Philadelphia, Pennsylvania, 19107
Barrow Neurology Clinic, St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
HOPE Research Institute
Phoenix, Arizona, 85050
Oregon Health & Science University, MS Center of Oregon, UHS-42
Portland, Oregon, 97239
Raleigh Neurology Associates
Raleigh, North Carolina, 27607
University of Rochester
Rochester, New York, 14642
UC Davis
Sacramento, California, 95817
Washington University School of Medicine
St Louis, Missouri, 63110
SUNY Stony Brook
Stony Brook, New York, 11794
Gimbel MS Center at Holy Name Hospital
Teaneck, New Jersey, 07666
Wake Forest University, Dept of Neurology, M.S. Research
Winston-Salem, North Carolina, 27157
Canada4 sites
Foothills Medical Center
Calgary, Alberta, T2N 2T9
River Valley Health c/o Stan Cassidy Centre for Rehabilitation
Fredericton, New Brunswick, E3B 0C7
QEII Health Sciences Centre, Nova Scotia Rehabilitation Centre Site
Halifax, Nova Scotia, B3H 4K4
University of British Columbia, Vancouver Coastal Health Research Institute
Vancouver, British Columbia, V6T 2B5
About this study
Official title: Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate Safety and Efficacy of Oral Fampridine-SR (10 mg b.i.d. [Bis in Die, Twice Daily]) in Patients With Multiple Sclerosis
The purpose of the study is to show that individuals treated with Fampridine-SR tablets are significantly more likely to have consistent improvements in their walking than those treated with placebo tablets.
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 MS patients
- Conditions
- Multiple Sclerosis
- Being tested
- Fampridine-SR, Placebo
- Keywords
- multiple sclerosis, MS, walking, leg strength, demyelination
- Medical subject headings
- Multiple Sclerosis, Demyelinating Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fampridine-SRDrug
Also called 4-aminopyridine
Tablets, 10 mg, twice daily, 9 weeks
PlaceboDrug
placebo (sugar pill)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo control Receives: Drug: Placebo |
| Fampridine-SR | Active comparator | 10 mg b.i.d. Receives: Drug: Fampridine-SR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responders Based Upon the Timed 25-Foot Walk [T25FW]
A responder is a patient who showed faster walking speed for at least 3 visits out of a possible 4 during the double-blind period than the maximum value achieved in the 5 non-double-blind no-treatment visits (4 before the double-blind period and one after)
Measured: Days -21, -14, -7, 0, 14, 28, 42, 56, 63, 77
Secondary outcomes (1)
Change in Lower Extremity Manual Muscle Test [LEMMT]
Evaluator rated strength in hip flexors, knee flexors, knee extensors, and ankle dorsiflexors on the following scale: best value = 5.0 (normal muscle strength), worst value = 0.0 (absence of any voluntary contraction). A positive shift in LEMMT score shows improvement in strength. Change in LEMMT scores for the secondary efficacy measure was found by averaging the LEMMT scores on days 14, 28, 42, and 56 (double-blind treatment period) and subtracting the baseline LEMMT score.
Measured: Days -21, -14, -7, 0, 14, 28, 42, 56, 63, 77
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2007 (estimated)
- Study startMay 2007
- Primary completionFeb 2008
- Study completionMay 2008
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
- 240 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
- NCT00483652
- Sponsor's protocol ID
- MS-F204
- Status last verified
- Jan 2016
- First submitted
- 6 Jun 2007
- Last updated
- 4 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Goodman AD, Brown TR, Edwards KR, Krupp LB, Schapiro RT, Cohen R, Marinucci LN, Blight AR; MSF204 Investigators. A phase 3 trial of extended release oral dalfampridine in multiple sclerosis. Ann Neurol. 2010 Oct;68(4):494-502. doi: 10.1002/ana.22240.
PubMed 20976768
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate Safety and Efficacy of Oral Fampridine-SR (10 mg b.i.d. [Bis in Die, Twice Daily]) in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00483652
- Acronym / sponsor ID
- MS-F204
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, MS, walking, leg strength, demyelination
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Acorda TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 7 Jun 2007 (estimated)
- Results
- Posted 14 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to show that individuals treated with Fampridine-SR tablets are significantly more likely to have consistent improvements in their walking than those treated with placebo tablets.
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
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 | Placebo comparator | Drug: PlaceboPlacebo control |
| Fampridine-SR | Active comparator | Drug: Fampridine-SR10 mg 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)
- Patient with clinically defined multiple sclerosis
- All patients must be able to complete two trials of a timed 25 foot walk
Key exclusion criteria (1 listed)
- Female patients who are either pregnant or breastfeeding.
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: 4-aminopyridineTablets, 10 mg, twice daily, 9 weeks | Drug | Fampridine-SR |
| Placeboplacebo (sugar pill) | Drug | Placebo |
Primary outcome
Responders Based Upon the Timed 25-Foot Walk [T25FW]
Time frame: Days -21, -14, -7, 0, 14, 28, 42, 56, 63, 77
A responder is a patient who showed faster walking speed for at least 3 visits out of a possible 4 during the double-blind period than the maximum value achieved in the 5 non-double-blind no-treatment visits (4 before the double-blind period and one after)
1 secondary outcome
Change in Lower Extremity Manual Muscle Test [LEMMT]
Time frame: Days -21, -14, -7, 0, 14, 28, 42, 56, 63, 77
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20976768Goodman AD, Brown TR, Edwards KR, Krupp LB, Schapiro RT, Cohen R, Marinucci LN, Blight AR; MSF204 Investigators. A phase 3 trial of extended release oral dalfampridine in multiple sclerosis. Ann Neurol. 2010 Oct;68(4):494-502. doi: 10.1002/ana.22240.
- Click here for more information about Fampridine-SR clinical trialsLink 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, PhD study director
Acorda Therapeutics
40 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 40 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 1 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 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 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 14 Apr 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?
Responders Based Upon the Timed 25-Foot Walk [T25FW] (time frame: Days -21, -14, -7, 0, 14, 28, 42, 56, 63, 77). 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 NCT00483652, 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 4 Feb 2016.