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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo control |
|
| Fampridine-SR | Active Comparator | 10 mg b.i.d. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fampridine-SR | Drug | Tablets, 10 mg, twice daily, 9 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Days -21, -14, -7, 0, 14, 28, 42, 56, 63, 77 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Blight, PhD | Acorda Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barrow Neurology Clinic, St. Joseph's Hospital and Medical Center | Phoenix | Arizona | 85013 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20976768 | Result | 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. |
| Label | URL |
|---|---|
| Click here for more information about Fampridine-SR clinical trials | View source |
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Two weeks of single-blind placebo run-in to establish baseline walking speeds
Patients with Multiple Sclerosis, enrolled at medical and MS clinics in USA and Canada; enrollment started 22 May 2007; last patient completed on 27 Feb 2008
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| ID | Title | Description |
|---|---|---|
| FG000 | Fampridine-SR 10 mg b.i.d. Treatment | Fampridine-SR 10 mg b.i.d. dosing for 9 weeks |
| FG001 | Placebo Treatment | Placebo b.i.d. dosing for 9 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-blind Treatment Period |
|
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| Placebo | Drug | placebo (sugar pill) |
|
| Days -21, -14, -7, 0, 14, 28, 42, 56, 63, 77 |
| HOPE Research Institute |
| Phoenix |
| Arizona |
| 85050 |
| United States |
| Neurological Associates | Fayetteville | Arkansas | 72703 | United States |
| Alta Bates Summit Medical Center - Research and Education Institute | Berkeley | California | 94705 | United States |
| USC, Keck School of Medicine Health Care Consultation Center | Los Angeles | California | 90033 | United States |
| UC Davis | Sacramento | California | 95817 | United States |
| Yale University MS Center | New Haven | Connecticut | 06510 | United States |
| Shepherd Center | Atlanta | Georgia | 30309 | United States |
| Consultants in Neurology, Ltd. | Northbrook | Illinois | 60062 | United States |
| Indiana University MS Center | Indianapolis | Indiana | 46202 | United States |
| Associates in Neurology, PSC | Lexington | Kentucky | 40503 | United States |
| Maryland Center for MS | Baltimore | Maryland | 21201 | United States |
| Lahey Clinic | Lexington | Massachusetts | 02421 | United States |
| The Schapiro Center for MS | Golden Valley | Minnesota | 55422 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Advanced Neurology Specialists | Great Falls | Montana | 59405 | United States |
| UMDNJ | Newark | New Jersey | 07103 | United States |
| Gimbel MS Center at Holy Name Hospital | Teaneck | New Jersey | 07666 | United States |
| Jacobs Neurological Institute Buffalo General Hospital | Buffalo | New York | 14203 | United States |
| Corinne Goldsmith Dickinson Center for MS | New York | New York | 10029 | United States |
| Columbia University Multiple Sclerosis Clinical Care Center | New York | New York | 10032 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| SUNY Stony Brook | Stony Brook | New York | 11794 | United States |
| CMC - Neuroscience & Spine Institute, Division of Neurology | Charlotte | North Carolina | 28207 | United States |
| Raleigh Neurology Associates | Raleigh | North Carolina | 27607 | United States |
| Wake Forest University, Dept of Neurology, M.S. Research | Winston-Salem | North Carolina | 27157 | United States |
| The Center for Neurological Services | Bismarck | North Dakota | 58501 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Ohio State University MS Center | Columbus | Ohio | 43221 | United States |
| Oregon Health & Science University, MS Center of Oregon, UHS-42 | Portland | Oregon | 97239 | United States |
| Thomas Jefferson University Physicians | Philadelphia | Pennsylvania | 19107 | United States |
| Neurological Research Center, Inc. | Bennington | Vermont | 05201 | United States |
| Fletcher Allen Health Care | Burlington | Vermont | 05401 | United States |
| MS Center at Evergreen | Kirkland | Washington | 98034 | United States |
| CAMC Health Education & Research Institute | Charleston | West Virginia | 25304 | United States |
| Center for Neurological Disorders of Aurora, St. Luke's Medical Center | Milwaukee | Wisconsin | 53215 | United States |
| Foothills Medical Center | Calgary | Alberta | T2N 2T9 | Canada |
| University of British Columbia, Vancouver Coastal Health Research Institute | Vancouver | British Columbia | V6T 2B5 | Canada |
| River Valley Health c/o Stan Cassidy Centre for Rehabilitation | Fredericton | New Brunswick | E3B 0C7 | Canada |
| QEII Health Sciences Centre, Nova Scotia Rehabilitation Centre Site | Halifax | Nova Scotia | B3H 4K4 | Canada |
| COMPLETED |
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| NOT COMPLETED |
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| Post-study Follow-up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fampridine-SR 10 mg b.i.d. Treatment | Fampridine-SR 10 mg b.i.d. dosing for 9 weeks |
| BG001 | Placebo Treatment | Placebo b.i.d. dosing for 9 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Modified Intention-to-Treat [ITT] population | Posted | Number | participants | Days -21, -14, -7, 0, 14, 28, 42, 56, 63, 77 |
|
|
| |||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Days -21, -14, -7, 0, 14, 28, 42, 56, 63, 77 |
|
|
14 Weeks
Treatment emergent: onset or worsening of AE on or after start of double-blind treatment up to 14 days after last dose of investigational drug OR up to 30 days after last dose for SAE
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fampridine-SR 10 mg b.i.d. Treatment | Fampridine-SR 10 mg b.i.d. dosing for 9 weeks | 5 | 120 | 103 | 120 | ||
| EG001 | Placebo Treatment | Placebo b.i.d. dosing for 9 weeks | 3 | 119 | 79 | 119 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyelonephritis | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
| |
| Gastroesophageal Reflux Disease | Gastrointestinal disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
| |
| Urinary tract Infection | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA (8.1) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Complex partial seizure | Nervous system disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Difficulty in walking | General disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (8.1) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (8.1) | Non-systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA (8.1) | Non-systematic Assessment |
| |
| White blood cell count decrease | Investigations | MedDRA (8.1) | Non-systematic Assessment |
| |
| Hypertriglyceridemia | Metabolism and nutrition disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Paresthesia | Nervous system disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Multiple Sclerosis relapse | Nervous system disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Muscle spasticity | Nervous system disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Non-systematic Assessment |
|
Sponsor (Acorda) has right to review and comment on proposed publications within a specified time frame, up to 60 days; multi-center trials require joint publication unless specifically permitted otherwise.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Blight, Chief Scientific Officer | Acorda Therapeutics, Inc. | (914) 347-4300 | 102 | ablight@acorda.com |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D003711 | Demyelinating Diseases |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D015761 | 4-Aminopyridine |
| ID | Term |
|---|---|
| D000631 | Aminopyridines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
|
|