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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo- sugar pill | Placebo Comparator | Placebo control |
|
| Fampridine-SR | Experimental | 10 milligram (mg) tablet b.i.d. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fampridine-SR | Drug | Tablets, 10 mg, twice daily, 14 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Days 14, 42, 70 and 98 of treatment, corresponding to the four on-drug visits during double-blind treatment period. |
| Measure | Description | Time Frame |
|---|---|---|
| Lower Extremity Manual Muscle Test; Ashworth Score for Spasticity | Days 14, 42, 70, 98 |
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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 |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35233 | United States | ||
| Barrow Neurology Clinic, St. Joseph's Hospital and Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19249634 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo- Sugar Pill | Placebo control group |
| FG001 | Fampridine-SR | 10 milligram (mg) tablet twice a day (b.i.d.) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | sugar pill, twice a day (b.i.d.) |
|
| Phoenix |
| Arizona |
| 85013 |
| United States |
| USC, Keck School of Medicine | Los Angeles | California | 90033 | United States |
| UC Davis | Sacramento | California | 95817 | United States |
| University of Colorado Health Sciences Center | Denver | Colorado | 80262 | United States |
| Multiple Sclerosis Treatment Center | Derby | Connecticut | 06418 | United States |
| Shepard Center | Atlanta | Georgia | 30309 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Indiana University MS Center | Indianapolis | Indiana | 46202 | United States |
| Maryland Center for MS | Baltimore | Maryland | 21201 | United States |
| Wayne State University, Department of Neurology | Detroit | Michigan | 48201 | United States |
| The Schapiro Center for MS | Golden Valley | Minnesota | 55422 | United States |
| Washington University SOM | St Louis | Missouri | 63110 | United States |
| Gimbel MS Center at Holy Name Hospital | Teaneck | New Jersey | 07666 | United States |
| University of Mexico, MIND Imaging Center | Albuquerque | New Mexico | 87131 | United States |
| Maimonides Medical Center | Brooklyn | New York | 11220 | United States |
| Corinne Goldsmith Dickinson Center for MS | New York | New York | 10029 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| SUNY - Stony Brook | Stony Brook | New York | 11794 | United States |
| Carolinas Healthcare System | Charlotte | North Carolina | 28207 | United States |
| Cleveland Clinical Foundation | Cleveland | Ohio | 44095 | 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 |
| Allegheny General Hospital, Allegheny Neurological Associates | Pittsburgh | Pennsylvania | 15212 | United States |
| University of Texas - Houston | Houston | Texas | 77030 | United States |
| Neurological Research Center, Inc. | Bennington | Vermont | 05201 | United States |
| Fletcher Allen Health Care | Burlington | Vermont | 05401 | United States |
| MS Hub Medical Group | Seattle | Washington | 98101 | United States |
| University of Washington, MS Research Center | Seattle | Washington | 98195 | 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 |
| QEII Health Sciences Centre, Nova Scotia Rehabilitation Centre Site | Halifax | Nova Scotia | B3H 4K4 | Canada |
| Ottawa Hospital General Campus | Ottawa | Ontario | K1H 8L6 | Canada |
| COMPLETED |
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| NOT COMPLETED |
|
Safety Population = Placebo (72), Fampridine-SR (228) Intent to Treat (ITT) Population = Placebo (72), Fampridine-SR (224).
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo- Sugar Pill | Placebo control group |
| BG001 | Fampridine-SR | 10 milligram (mg) tablet twice a day (b.i.d.) |
| 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 |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | 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 | 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. | ITT Population | Posted | Number | Participants | Days 14, 42, 70 and 98 of treatment, corresponding to the four on-drug visits during double-blind treatment period. |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Lower Extremity Manual Muscle Test; Ashworth Score for Spasticity | Not Posted | Days 14, 42, 70, 98 | Participants |
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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 | Placebo- Sugar Pill | Placebo control group | 0 | 72 | 58 | 72 | ||
| EG001 | Fampridine-SR | 10 milligram (mg) tablet twice a day (b.i.d.) | 16 | 228 | 191 | 228 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Vascular disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.1) | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (8.1) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
| |
| Multiple sclerosis | Nervous system disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Neck injury | Injury, poisoning and procedural complications | MedDRA (8.1) | Non-systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA (8.1) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
| |
| Surgery | Surgical and medical procedures | MedDRA (8.1) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
| |
| Wound infection | Injury, poisoning and procedural complications | MedDRA (8.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| asthenia | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| back pain | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| balance disorder | Nervous system disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| dizziness | Nervous system disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| fall | Injury, poisoning and procedural complications | MedDRA (8.1) | Non-systematic Assessment |
| |
| fatigue | General disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| headache | Nervous system disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| insomnia | Nervous system disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Upper Respiratory Tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
| |
| Multiple Sclerosis | Vascular disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (8.1) | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system 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 |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating 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 |
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| Black |
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| Hispanic |
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| Asian/Pacific Islander |
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| Other |
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