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The purpose of the study is to evaluate the safety, tolerability and activity of Fampridine-SR when administered for up to 36 additional months in patients who previously participated in the MS-F204 study or until it becomes commercially available, whichever comes first.
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 over a long period of time.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fampridine-SR | Drug | Tablets, 10 mg, BID (twice daily) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Summary of Treatment Emergent Adverse Events (TEAE). | All adverse events reported were treatment emergent. Therefore, events that had a date of onset, or worsening, on or after the start of the open-label drug and up to 14 days after the last dose (for non-serious events) or up to 30 days after the last dose (for SAEs) were summarized. Any abnormal clinically significant changes in physical examination, medical history, clinical laboratory testing, 12-lead ECG, and standard EEG testing were captured as adverse events. | up to 40 months |
| Measure | Description | Time Frame |
|---|---|---|
| Timed 25-Foot Walk (T25FW) | Week 2, 14, 26, continuing every 26 weeks until the Final Visit | |
| Subject Global Impression (SGI) | For the SGI, the potential responses to the effects of the investigational drug during the preceding week were 1=terrible, 2=unhappy, 3=mostly dissatisfied, 4=neutral/ mixed, 5=mostly satisfied, 6=pleased, and 7=delighted. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bonnie Faust | 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 | ||
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| Label | URL |
|---|---|
| Click here for more information about Fampridine-SR clinical trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fampridine-SR | Tablets, 10 mg, BID |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Visit 1 and every clinic visit thereafter (other than the follow-up visit) |
| Clinician's Global Impression (CGI) | The potential responses were 1=very much improved, 2=much improved, 3=somewhat improved, 4=no change, 5=somewhat worse, 6=much worse, and 7=very much worse. | Visit 1 and every clinic visit thereafter |
| Expanded Disability Status Scale (EDSS) | The EDSS was used to grade patient disability on a scale from 0.0 (normal neurological exam) to 10.0 (death) | The Screening Visit, Visit 6, Final Visit or Early Termination Visit (if applicable) |
| 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 |
| University of Chicago | Chicago | Illinois | 60637 | 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 |
| Wayne State University, Department of Neurology | Detroit | Michigan | 48201 | 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 |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fampridine-SR | Tablets, 10 mg, BID |
| Units | Counts |
|---|---|
| Participants |
|
| 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 |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | 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 | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Timed 25-Foot Walk (T25FW) | ITT Population. No imputation for missing data | Posted | Mean | Standard Deviation | feet/seconds | Week 2, 14, 26, continuing every 26 weeks until the Final Visit |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Subject Global Impression (SGI) | For the SGI, the potential responses to the effects of the investigational drug during the preceding week were 1=terrible, 2=unhappy, 3=mostly dissatisfied, 4=neutral/ mixed, 5=mostly satisfied, 6=pleased, and 7=delighted. | ITT Population. No imputation for missing data | Posted | Mean | Standard Deviation | 1-7 scale rating | Visit 1 and every clinic visit thereafter (other than the follow-up visit) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Clinician's Global Impression (CGI) | The potential responses were 1=very much improved, 2=much improved, 3=somewhat improved, 4=no change, 5=somewhat worse, 6=much worse, and 7=very much worse. | ITT Population. No imputation for missing data | Posted | Mean | Standard Deviation | 1-7 scale rating | Visit 1 and every clinic visit thereafter |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Expanded Disability Status Scale (EDSS) | The EDSS was used to grade patient disability on a scale from 0.0 (normal neurological exam) to 10.0 (death) | ITT Population. No imputation for missing data | Posted | Mean | Standard Deviation | 0-10 rating scale | The Screening Visit, Visit 6, Final Visit or Early Termination Visit (if applicable) |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Summary of Treatment Emergent Adverse Events (TEAE). | All adverse events reported were treatment emergent. Therefore, events that had a date of onset, or worsening, on or after the start of the open-label drug and up to 14 days after the last dose (for non-serious events) or up to 30 days after the last dose (for SAEs) were summarized. Any abnormal clinically significant changes in physical examination, medical history, clinical laboratory testing, 12-lead ECG, and standard EEG testing were captured as adverse events. | Safety Population. No imputation for missing data | Posted | Number | participants | up to 40 months |
|
|
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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 | Tablets, 10 mg, BID | 39 | 214 | 205 | 214 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Accidental Overdose | Injury, poisoning and procedural complications | MedDRA (8.1) |
| ||
| Arthritis Infective | Infections and infestations | MedDRA (8.1) |
| ||
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (8.1) |
| ||
| Bile Duct Stone | Hepatobiliary disorders | MedDRA (8.1) |
| ||
| Bronchitis | Infections and infestations | MedDRA (8.1) |
| ||
| Carotid Artery Stenosis | Nervous system disorders | MedDRA (8.1) |
| ||
| Cellulitis | Infections and infestations | MedDRA (8.1) |
| ||
| Cholecystitis | Hepatobiliary disorders | MedDRA (8.1) |
| ||
| Clostridium Colitis | Infections and infestations | MedDRA (8.1) |
| ||
| Colitis | Gastrointestinal disorders | MedDRA (8.1) |
| ||
| Completed Suicide | Psychiatric disorders | MedDRA (8.1) |
| ||
| Coronary Artery Disease | Cardiac disorders | MedDRA (8.1) |
| ||
| Dehydration | Metabolism and nutrition disorders | MedDRA (8.1) |
| ||
| Device Related Infection | Injury, poisoning and procedural complications | MedDRA (8.1) |
| ||
| Dizziness | Nervous system disorders | MedDRA (8.1) |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) |
| ||
| Fall | Injury, poisoning and procedural complications | MedDRA (8.1) |
| ||
| Gastritis | Gastrointestinal disorders | MedDRA (8.1) |
| ||
| Headache | Nervous system disorders | MedDRA (8.1) |
| ||
| Intestinal Perforation | Gastrointestinal disorders | MedDRA (8.1) |
| ||
| Lower Limb Fracture | Injury, poisoning and procedural complications | MedDRA (8.1) |
| ||
| Lumbar Puncture Headache | Injury, poisoning and procedural complications | MedDRA (8.1) |
| ||
| Multiple Sclerosis Relapse | Nervous system disorders | MedDRA (8.1) |
| ||
| Muscle Spasticity | Nervous system disorders | MedDRA (8.1) |
| ||
| Nausea | Gastrointestinal disorders | MedDRA (8.1) |
| ||
| Oesophagitis | Gastrointestinal disorders | MedDRA (8.1) |
| ||
| Orbital Infection | Infections and infestations | MedDRA (8.1) |
| ||
| Otitis Externa | Infections and infestations | MedDRA (8.1) |
| ||
| Ovarian Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.1) |
| ||
| Overdose | Injury, poisoning and procedural complications | MedDRA (8.1) |
| ||
| Pneumonia | Infections and infestations | MedDRA (8.1) |
| ||
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.1) |
| ||
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) |
| ||
| Sepsis | Infections and infestations | MedDRA (8.1) |
| ||
| Spinal Fracture | Injury, poisoning and procedural complications | MedDRA (8.1) |
| ||
| Suicide Attempt | Psychiatric disorders | MedDRA (8.1) |
| ||
| Syncope | Nervous system disorders | MedDRA (8.1) |
| ||
| Tibia Fracture | Injury, poisoning and procedural complications | MedDRA (8.1) |
| ||
| Tuberculosis | Infections and infestations | MedDRA (8.1) |
| ||
| Urinary Tract Infection | Infections and infestations | MedDRA (8.1) |
| ||
| Urosepsis | Infections and infestations | MedDRA (8.1) |
| ||
| Uterine Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.1) |
| ||
| Vertigo | Ear and labyrinth disorders | MedDRA (8.1) |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adverse Drug Reaction | General disorders | MedDRA (8.1) |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (8.1) |
| ||
| Asthenia | General disorders | MedDRA (8.1) |
| ||
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (8.1) |
| ||
| Balance Disorder | Nervous system disorders | MedDRA (8.1) |
| ||
| Blood Creatine Phosphokinase Increased | Investigations | MedDRA (8.1) |
| ||
| Contusion | Injury, poisoning and procedural complications | MedDRA (8.1) |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) |
| ||
| Depression | Psychiatric disorders | MedDRA (8.1) |
| ||
| Dizziness | Nervous system disorders | MedDRA (8.1) |
| ||
| Fall | Injury, poisoning and procedural complications | MedDRA (8.1) |
| ||
| Fatique | General disorders | MedDRA (8.1) |
| ||
| Headache | Nervous system disorders | MedDRA (8.1) |
| ||
| Hypoaesthesia | Nervous system disorders | MedDRA (8.1) |
| ||
| Influenza | Infections and infestations | MedDRA (8.1) |
| ||
| Insomnia | Psychiatric disorders | MedDRA (8.1) |
| ||
| Multiple Sclerosis Relapse | Nervous system disorders | MedDRA (8.1) |
| ||
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA (8.1) |
| ||
| Muscle Spasticity | Nervous system disorders | MedDRA (8.1) |
| ||
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA (8.1) |
| ||
| Nasopharyngitis | Infections and infestations | MedDRA (8.1) |
| ||
| Nausea | Gastrointestinal disorders | MedDRA (8.1) |
| ||
| Oedema Peripheral | General disorders | MedDRA (8.1) |
| ||
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA (8.1) |
| ||
| Pyrexia | General disorders | MedDRA (8.1) |
| ||
| Rash | Skin and subcutaneous tissue disorders | MedDRA (8.1) |
| ||
| Shoulder Pain | Musculoskeletal and connective tissue disorders | MedDRA (8.1) |
| ||
| Sinusitis | Infections and infestations | MedDRA (8.1) |
| ||
| Skin Laceration | Injury, poisoning and procedural complications | MedDRA (8.1) |
| ||
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (8.1) |
| ||
| Urinary Tract Infection | Infections and infestations | MedDRA (8.1) |
|
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, PhD Chief Scientific Officer | Acorda Therapeutics, Inc. | 914-347-4300 | 4102 | 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 |
Not provided
Not provided
| 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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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|
| (N=172) >42-68 Weeks |
|
| (N=160) >68-94 Weeks |
|
| (N=151) >94-120 Weeks |
|
| (N=143) >120-146 Weeks |
|
| (N=33) >146-172 Weeks |
|
| (N=2) >172-198 Weeks |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| (N=214) >0-8 Weeks |
| |||||
| (N=200) >8-16 Weeks |
| |||||
| (N=199) >16-42 Weeks |
| |||||
| (N=183) >42-68 Weeks |
| |||||
| (N=173) >68-94 Weeks |
| |||||
| (N=167) >94-120 Weeks |
| |||||
| (N=153) >120-146 Weeks |
| |||||
| (N=35) >146-172 Weeks |
| |||||
| (N=2) >172-198 Weeks |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| (N=213) >0-8 Weeks |
| |||||
| (N=202) >8-16 Weeks |
| |||||
| (N=208) >16-42 Weeks |
| |||||
| (N=181) >42-68 Weeks |
| |||||
| (N=172) >68-94 Weeks |
| |||||
| (N=168) >94-120 Weeks |
| |||||
| (N=154) >120-146 Weeks |
| |||||
| (N=35) >146-172 Weeks |
| |||||
| (N=2) >172-198 Weeks |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| (N=213) Baseline |
| |||||
| (N=163) >94-120 Weeks |
|
|