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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Placebo control, twice a day (b.i.d.) |
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| 2 | Experimental | 10 milligram (mg) fampridine b.i.d. |
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| 3 | Experimental | 15 mg fampridine b.i.d. |
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| 4 | Experimental | 20 mg fampridine b.i.d. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo for 15 weeks |
| |
| 10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline (placebo run-in period); 12-week stable dose period |
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INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barrow Neurological Institute at St. Joseph Hospital and Medical Center | Phoenix | Arizona | 85013 | United States | ||
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| Label | URL |
|---|---|
| Related Info | View source |
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2-week placebo run-in
Patients with clinically definite MS were recruited at clinics within the US and Canada
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo control |
| FG001 | 10 mg Fampridine Twice a Day (b.i.d.) | fampridine, oral, 10 mg administered twice daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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) |
|
| USC MS Comprehensive Care Center |
| Los Angeles |
| California |
| 90033 |
| United States |
| Yale University MS Center | New Haven | Connecticut | 06510 | United States |
| Shepherd Center | Atlanta | Georgia | 30309 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| University of Maryland at Baltimore | Baltimore | Maryland | 21210 | United States |
| Fairview MS Center | Minneapolis | Minnesota | 55454 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Gimbel MS Center | Teaneck | New Jersey | 07666 | United States |
| University of New Mexico | Albuquerque | New Mexico | 87131 | United States |
| Maimonides MS Care Center | Brooklyn | New York | 11219 | United States |
| Mt. Sinai School of Medicine - MS Center | New York | New York | 10029 | United States |
| University of Rochester Medical School | Rochester | New York | 14642 | United States |
| SUNY Stony Brook | Stony Brook | New York | 11794 | United States |
| Carolinas Medical Center MS Center | Charlotte | North Carolina | 28207 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Oregon Health Sciences University; MS Center | Portland | Oregon | 97201 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| University of Texas-Houston | Houston | Texas | 77030 | United States |
| Swedish Medical MS Center | Seattle | Washington | 98122 | United States |
| University of Washington School of Medicine | Seattle | Washington | 98195 | United States |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | United States |
| Foothills Medical Centre | Calgary | Alberta | T2N 2T9 | Canada |
| St. Michael's Hospital | Toronto | Ontario | M5B 1WB | Canada |
| FG002 | 15 mg Fampridine b.i.d. | fampridine, oral, 15 mg administered twice daily |
| FG003 | 20 mg Fampridine b.i.d. | fampridine, oral, 20 mg administered twice daily |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo control |
| BG001 | 10 mg Fampridine Twice a Day (b.i.d.) | fampridine, oral, 10 mg administered twice daily |
| BG002 | 15 mg Fampridine b.i.d. | fampridine, oral, 15 mg administered twice daily |
| BG003 | 20 mg Fampridine b.i.d. | fampridine, oral, 20 mg administered twice daily |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | 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). | Posted | Median | Full Range | percent change | Baseline (placebo run-in period); 12-week stable dose period |
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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 | Placebo control | 2 | 47 | 38 | 47 | ||
| EG001 | 10 mg Fampridine Twice a Day (b.i.d.) | fampridine, oral, 10 mg administered twice daily | 0 | 52 | 45 | 52 | ||
| EG002 | 15 mg Fampridine b.i.d. | fampridine, oral, 15 mg administered twice daily | 4 | 50 | 47 | 50 | ||
| EG003 | 20 mg Fampridine b.i.d. | fampridine, oral, 20 mg administered twice daily | 7 | 57 | 52 | 57 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA |
| ||
| Complex Partial Seizures | Nervous system disorders | MedDRA |
| ||
| Convulsion | Nervous system disorders | MedDRA |
| ||
| Kidney Infection | Infections and infestations | MedDRA |
| ||
| Mental Disorder | Psychiatric disorders | MedDRA |
| ||
| Multiple Sclerosis | Nervous system disorders | MedDRA |
| ||
| Myocardial Infarction | Cardiac disorders | MedDRA |
| ||
| Nausea | Gastrointestinal disorders | MedDRA |
| ||
| Vomiting | Gastrointestinal disorders | MedDRA |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia | General disorders | MedDRA |
| ||
| Balance Disorder | Nervous system disorders | MedDRA |
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| Dizziness | Nervous system disorders | MedDRA |
| ||
| Fall | Injury, poisoning and procedural complications | MedDRA |
| ||
| Fatigue | General disorders | MedDRA |
| ||
| Headache | Nervous system disorders | MedDRA |
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| Insomnia | Psychiatric disorders | MedDRA |
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| Multiple Sclerosis | Nervous system disorders | MedDRA |
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| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA |
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| Nausea | Gastrointestinal disorders | MedDRA |
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| Oedema Peripheral | General disorders | MedDRA |
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| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA |
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| Paraesthesia | Nervous system disorders | MedDRA |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA |
| ||
| Urinary Tract Infection | Infections and infestations | MedDRA |
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The INSTITUTION shall submit any such manuscript or release to the SPONSOR for comment prior to publication or release at least forty-five (45) days in advance of submission for publication. If the parties disagree concerning appropriateness of the data analysis and presentation, INSTITUTION agrees to meet with SPONSOR's representatives for the purpose of making good faith efforts to discuss and resolve any issues or disagreement.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Blight, PhD | Acorda Therapeutics | 914-347-4300 | 102 | ablight@acorda.com |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D009128 | Muscle Spasticity |
| 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 |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Canada |
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