Multiple SclerosisPhase 2NCT00053417
Safety and Efficacy Study of Oral Fampridine-SR in Patients With Multiple Sclerosis
A Phase 2 study testing 10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP), 15 mg fampridine-SR (4-aminopyridine, 4-AP) and 20 mg fampridine-SR (4-aminopyridine, 4-AP) in people with Multiple Sclerosis, run by Acorda Therapeutics at 25 sites in 2 countries.
Trial summary
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. 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?
- 10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP), 15 mg fampridine-SR (4-aminopyridine, 4-AP) and 20 mg fampridine-SR (4-aminopyridine, 4-AP)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 206 participants
- Where
- 25 sitesin 2 countries
- Study dates
- Feb 2003to Dec 2003
- Phase
- Phase 2
- 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 assisted 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
25 sites in 2 countries.
25 sites in 2 countries
United States23 sites
University of New Mexico
Albuquerque, New Mexico, 87131
Shepherd Center
Atlanta, Georgia, 30309
University of Maryland at Baltimore
Baltimore, Maryland, 21210
Maimonides MS Care Center
Brooklyn, New York, 11219
Carolinas Medical Center MS Center
Charlotte, North Carolina, 28207
University of Chicago
Chicago, Illinois, 60637
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Ohio State University
Columbus, Ohio, 43210
University of Texas-Houston
Houston, Texas, 77030
USC MS Comprehensive Care Center
Los Angeles, California, 90033
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
Fairview MS Center
Minneapolis, Minnesota, 55454
Yale University MS Center
New Haven, Connecticut, 06510
Mt. Sinai School of Medicine - MS Center
New York, New York, 10029
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Barrow Neurological Institute at St. Joseph Hospital and Medical Center
Phoenix, Arizona, 85013
Oregon Health Sciences University; MS Center
Portland, Oregon, 97201
University of Rochester Medical School
Rochester, New York, 14642
Swedish Medical MS Center
Seattle, Washington, 98122
University of Washington School of Medicine
Seattle, Washington, 98195
Washington University School of Medicine
St Louis, Missouri, 63110
SUNY Stony Brook
Stony Brook, New York, 11794
Gimbel MS Center
Teaneck, New Jersey, 07666
Canada2 sites
Foothills Medical Centre
Calgary, Alberta, T2N 2T9
St. Michael's Hospital
Toronto, Ontario, M5B 1WB
About this study
Official title: Double-Blind, Placebo-Controlled, 20-Week, Parallel Group Study to Evaluate Safety, Tolerability and Activity of Oral Fampridine-SR in Subjects With Multiple Sclerosis
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 (Sustained Release, SR) is an experimental drug that increases the ability of the nerve to conduct electrical impulses. This study will evaluate the effects of Fampridine-SR on the walking ability of subjects with MS, as well as to examine the effects on muscle strength and spasticity. The study will also examine the possible risks of taking Fampridine-SR.
- Conditions
- Multiple Sclerosis
- Being tested
- Placebo, 10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP), 15 mg fampridine-SR (4-aminopyridine, 4-AP), 20 mg fampridine-SR (4-aminopyridine, 4-AP)
- Keywords
- Walking Ability, Muscle strength, Spasticity
- Medical subject headings
- Multiple Sclerosis, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo for 15 weeks
10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP)Drug
2 week up titration (10 mg)
12 weeks stable dose (10 mg)
1 week down titration (10 mg)
15 mg fampridine-SR (4-aminopyridine, 4-AP)Drug
10 mg twice daily for 1 week
15 mg twice daily for 14 weeks
2 week up titration (10 mg x 1 week, 15 mg x 1 week)
12 weeks stable dose (15 mg)
1 week down titration (10 mg)
20 mg fampridine-SR (4-aminopyridine, 4-AP)Drug
2 week up titration (10 mg x 1 week, 15 mg x 1 week)
12 weeks stable dose (20 mg)
1 week down titration (15 mg x 3 days, 10 mg x 4 days)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo control, twice a day (b.i.d.) Receives: Drug: Placebo |
| 2 | Experimental | 10 milligram (mg) fampridine b.i.d. Receives: Drug: 10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP) |
| 3 | Experimental | 15 mg fampridine b.i.d. Receives: Drug: 15 mg fampridine-SR (4-aminopyridine, 4-AP) |
| 4 | Experimental | 20 mg fampridine b.i.d. Receives: Drug: 20 mg fampridine-SR (4-aminopyridine, 4-AP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Percent Change From Baseline in Average Walking Speed on Timed 25-Foot Walk Test
The primary efficacy variable was the percent change from baseline in average walking speed measured using the Timed 25-Foot Walk Test during the 12-week stable dose period (the average of Study Days 56, 84, and 112), relative to the mean at baseline (placebo run-in period, the average of Study Days 7 and 14).
Measured: Baseline (placebo run-in period); 12-week stable dose period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2003 (estimated)
- Study startFeb 2003
- Primary completionDec 2003
- Study completionDec 2003
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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acorda Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00053417
- Sponsor's protocol ID
- MS-F202
- Status last verified
- Aug 2011
- First submitted
- 29 Jan 2003
- Last updated
- 4 Aug 2011
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Placebo-Controlled, 20-Week, Parallel Group Study to Evaluate Safety, Tolerability and Activity of Oral Fampridine-SR in Subjects With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00053417
- Acronym / sponsor ID
- MS-F202
- Conditions
- Multiple Sclerosis
- Keywords
- Walking Ability, Muscle strength, Spasticity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Acorda TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- Primary completion
- Dec 2003 (actual)
- Study completion
- Dec 2003 (actual)
- First posted
- 30 Jan 2003 (estimated)
- Results
- Posted 4 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (Sustained Release, SR) is an experimental drug that increases the ability of the nerve to conduct electrical impulses. This study will evaluate the effects of Fampridine-SR on the walking ability of subjects with MS, as well as to examine the effects on muscle strength and spasticity. The study will also examine the possible risks of taking Fampridine-SR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: PlaceboPlacebo control, twice a day (b.i.d.) |
| 2 | Experimental | Drug: 10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP)10 milligram (mg) fampridine b.i.d. |
| 3 | Experimental | Drug: 15 mg fampridine-SR (4-aminopyridine, 4-AP)15 mg fampridine b.i.d. |
| 4 | Experimental | Drug: 20 mg fampridine-SR (4-aminopyridine, 4-AP)20 mg fampridine 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 assisted 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 |
|---|---|---|
| PlaceboPlacebo for 15 weeks | Drug | 1 |
| 10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP)2 week up titration (10 mg) 12 weeks stable dose (10 mg) 1 week down titration (10 mg) | Drug | 2 |
| 15 mg fampridine-SR (4-aminopyridine, 4-AP)10 mg twice daily for 1 week 15 mg twice daily for 14 weeks 2 week up titration (10 mg x 1 week, 15 mg x 1 week) 12 weeks stable dose (15 mg) 1 week down titration (10 mg) | Drug | 3 |
| 20 mg fampridine-SR (4-aminopyridine, 4-AP)2 week up titration (10 mg x 1 week, 15 mg x 1 week) 12 weeks stable dose (20 mg) 1 week down titration (15 mg x 3 days, 10 mg x 4 days) | Drug | 4 |
Primary outcome
Median Percent Change From Baseline in Average Walking Speed on Timed 25-Foot Walk Test
Time frame: Baseline (placebo run-in period); 12-week stable dose period
The primary efficacy variable was the percent change from baseline in average walking speed measured using the Timed 25-Foot Walk Test during the 12-week stable dose period (the average of Study Days 56, 84, and 112), relative to the mean at baseline (placebo run-in period, the average of Study Days 7 and 14).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2011.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP), 15 mg fampridine-SR (4-aminopyridine, 4-AP) and 20 mg fampridine-SR (4-aminopyridine, 4-AP) in people with Multiple Sclerosis, run by Acorda Therapeutics at 25 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 4 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 4 Aug 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?
Median Percent Change From Baseline in Average Walking Speed on Timed 25-Foot Walk Test (time frame: Baseline (placebo run-in period); 12-week stable dose period). 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 4 Aug 2011.