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The purpose of this study is to evaluate the safety, tolerability and activity of Fampridine-SR when administered for up to 36 additional months, or until it becomes commercially available whichever comes first, in subjects who previously participated in Acorda Therapeutics Protocol MS-F203.
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 |
|
| 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 5 years |
| 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) | Patients asked to complete a Subject Impression questionnaire rating his/her impression of the effects of study drug during the preceding week, specifically in regards to signs and symptoms associated with Multiple Sclerosis (MS). 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 | ||
Not provided
| 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, 10mg twice daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| visit 1 and every clinic visit |
| Clinician Global Impression of Change (CGIC) | Investigator's overall impression of the patients neurological status and general state of health related to his/her participation in the study; specifically signs and symptoms associated with MS. 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 |
| Expanded Disability Status Scale (EDSS) | Each patient, based on their baseline neurological exam, are scored according to the EDSS The EDSS was used to grade patient disability on a scale from 0.0 (normal neurological exam) to 10.0 (death) at the Screening Visit, Visit 6, and Final Visit or Early Termination Visit if applicable. | Screening visit, visit 6 and every 24 months thereafter |
| USC, Keck School of Medicine Health Care Consultation Center |
| Los Angeles |
| California |
| 90033 |
| United States |
| UC Davis | Sacramento | California | 95817 | United States |
| Shepherd 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 School of Medicine, Div. of Rehab/Neurology | St Louis | Missouri | 63110 | United States |
| Advanced Neurology Specialists | Great Falls | Montana | 59405 | United States |
| Gimbel MS Center at Holy Name Hospital | Teaneck | New Jersey | 07666 | United States |
| Maimonides MS Care Center | Brooklyn | New York | 11219 | 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 |
| CMC - Neuroscience & Spine Institute, Division of Neurology | Charlotte | North Carolina | 28207 | United States |
| Raleigh Neurology Associates | Raleigh | North Carolina | 27607 | 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 |
| 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 Center at Evergreen | Kirkland | Washington | 98034 | 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 |
| Ottawa Hospital General Campus | Ottawa | Ontario | K1H 8L6 | Canada |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fampridine-SR | Tablets, 10mg twice daily |
| 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 | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 5 years |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Timed 25 Foot Walk (T25FW) | ITT Population. No imputation for missing data | Posted | Mean | Standard Deviation | feet/second | Week 2, 14, 26, continuing every 26 weeks until the Final Visit |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Subject Global Impression (SGI) | Patients asked to complete a Subject Impression questionnaire rating his/her impression of the effects of study drug during the preceding week, specifically in regards to signs and symptoms associated with Multiple Sclerosis (MS). 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 | units on a scale | visit 1 and every clinic visit |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Clinician Global Impression of Change (CGIC) | Investigator's overall impression of the patients neurological status and general state of health related to his/her participation in the study; specifically signs and symptoms associated with MS. 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 | units on a scale | visit 1 and every clinic visit |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Expanded Disability Status Scale (EDSS) | Each patient, based on their baseline neurological exam, are scored according to the EDSS The EDSS was used to grade patient disability on a scale from 0.0 (normal neurological exam) to 10.0 (death) at the Screening Visit, Visit 6, and Final Visit or Early Termination Visit if applicable. | ITT Population. No imputation for missing data | Posted | Mean | Standard Deviation | units on a scale | Screening visit, visit 6 and every 24 months thereafter |
|
|
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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, 10mg twice daily | 94 | 269 | 264 | 269 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA (8.1) |
| ||
| Acute Coronary Syndrome | Cardiac disorders | MedDRA (8.1) |
| ||
| Affective Disorder | Psychiatric disorders | MedDRA (8.1) |
| ||
| Anxiety | Psychiatric disorders | MedDRA (8.1) |
| ||
| Aortic Valve Incompetence | Cardiac disorders | MedDRA (8.1) |
| ||
| Aphagia | Gastrointestinal disorders | MedDRA (8.1) |
| ||
| Aphonia | Nervous system disorders | MedDRA (8.1) |
| ||
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (8.1) |
| ||
| Asthenia | General disorders | MedDRA (8.1) |
| ||
| Atrial Fibrillation | Cardiac disorders | MedDRA (8.1) |
| ||
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (8.1) |
| ||
| Bacterial Pyelonephritis | Infections and infestations | MedDRA (8.1) |
| ||
| Bile Duct Stenosis | Hepatobiliary disorders | MedDRA (8.1) |
| ||
| Bipolar I Disorder | Psychiatric disorders | MedDRA (8.1) |
| ||
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.1) |
| ||
| Breast Cancer in Situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.1) |
| ||
| Bronchitis | Infections and infestations | MedDRA (8.1) |
| ||
| Candida Sepsis | Infections and infestations | MedDRA (8.1) |
| ||
| Cardiac Failure Congestive | Cardiac disorders | MedDRA (8.1) |
| ||
| Cardiogenic Shock | Cardiac disorders | MedDRA (8.1) |
| ||
| Cellulitis | Infections and infestations | MedDRA (8.1) |
| ||
| Cellulitis Staphylococcal | Infections and infestations | MedDRA (8.1) |
| ||
| Cerebral Haemorrhage | Nervous system disorders | MedDRA (8.1) |
| ||
| Cervical Cord Compression | Nervous system disorders | MedDRA (8.1) |
| ||
| Chest Discomfort | General disorders | MedDRA (8.1) |
| ||
| Chest Pain | General disorders | MedDRA (8.1) |
| ||
| Cholecystitis Acute | Hepatobiliary disorders | MedDRA (8.1) |
| ||
| Cholelithiasis | Hepatobiliary disorders | MedDRA (8.1) |
| ||
| Clostridial Infection | Infections and infestations | MedDRA (8.1) |
| ||
| Clostridium Colitis | Infections and infestations | MedDRA (8.1) |
| ||
| Completed Suicide | Psychiatric disorders | MedDRA (8.1) |
| ||
| Complex Partial Seizures | Nervous system disorders | MedDRA (8.1) |
| ||
| Congestive Cardiomyopathy | Cardiac disorders | MedDRA (8.1) |
| ||
| Convulsion | Nervous system disorders | MedDRA (8.1) |
| ||
| Deep Vein Thrombosis | Vascular disorders | MedDRA (8.1) |
| ||
| Device Failure | Injury, poisoning and procedural complications | MedDRA (8.1) |
| ||
| Diabetes Mellitus Inadequate Control | Metabolism and nutrition disorders | MedDRA (8.1) |
| ||
| Dysphagia | Gastrointestinal disorders | MedDRA (8.1) |
| ||
| Face Injury | Injury, poisoning and procedural complications | MedDRA (8.1) |
| ||
| Fall | Injury, poisoning and procedural complications | MedDRA (8.1) |
| ||
| Gastroenteritis | Infections and infestations | MedDRA (8.1) |
| ||
| Grand Mal Convulsion | Nervous system disorders | MedDRA (8.1) |
| ||
| Hip Fracture | Injury, poisoning and procedural complications | MedDRA (8.1) |
| ||
| Hyperparathyroidism Primary | Endocrine disorders | MedDRA (8.1) |
| ||
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (8.1) |
| ||
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA (8.1) |
| ||
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA (8.1) |
| ||
| Intestinal Perforation | Gastrointestinal disorders | MedDRA (8.1) |
| ||
| Joint Injury | Injury, poisoning and procedural complications | MedDRA (8.1) |
| ||
| Limb Injury | Injury, poisoning and procedural complications | MedDRA (8.1) |
| ||
| Lower Limb Fracture | Injury, poisoning and procedural complications | MedDRA (8.1) |
| ||
| Major Depression | Psychiatric disorders | MedDRA (8.1) |
| ||
| Malaise | General disorders | MedDRA (8.1) |
| ||
| Medical Observation | Investigations | MedDRA (8.1) |
| ||
| Menorrhagia | Renal and urinary disorders | MedDRA (8.1) |
| ||
| Metastatic Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 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) |
| ||
| Myocardial Infarction | Cardiac disorders | MedDRA (8.1) |
| ||
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.1) |
| ||
| Nervous System Disorder | Nervous system disorders | MedDRA (8.1) |
| ||
| Neurogenic Bladder | Renal and urinary disorders | MedDRA (8.1) |
| ||
| Nodal Rhythm | Cardiac disorders | MedDRA (8.1) |
| ||
| Non-Cardiac Chest Pain | General disorders | MedDRA (8.1) |
| ||
| Obesity | Metabolism and nutrition disorders | MedDRA (8.1) |
| ||
| Open Wound | Injury, poisoning and procedural complications | MedDRA (8.1) |
| ||
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (8.1) |
| ||
| Ovarian Adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.1) |
| ||
| Pancreatitis | Gastrointestinal disorders | MedDRA (8.1) |
| ||
| Parvovirus Infection | Infections and infestations | MedDRA (8.1) |
| ||
| Peripheral Vascular Disorder | Vascular disorders | MedDRA (8.1) |
| ||
| Peritonitis | Gastrointestinal disorders | MedDRA (8.1) |
| ||
| Pneumonia | Infections and infestations | MedDRA (8.1) |
| ||
| Pneumonia Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) |
| ||
| Polytraumatism | Injury, poisoning and procedural complications | MedDRA (8.1) |
| ||
| Postoperative Abscess | Infections and infestations | MedDRA (8.1) |
| ||
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (8.1) |
| ||
| Procedural Site Reaction | Injury, poisoning and procedural complications | MedDRA (8.1) |
| ||
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) |
| ||
| Pyelonephritis | Infections and infestations | MedDRA (8.1) |
| ||
| Pyrexia | General disorders | MedDRA (8.1) |
| ||
| Renal Cell Carcinoma Stage Unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.1) |
| ||
| Renal Failure Acute | Renal and urinary disorders | MedDRA (8.1) |
| ||
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) |
| ||
| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA (8.1) |
| ||
| Rotator Cuff Syndrome | Musculoskeletal and connective tissue disorders | MedDRA (8.1) |
| ||
| Sepsis | Infections and infestations | MedDRA (8.1) |
| ||
| Septic Shock | Infections and infestations | MedDRA (8.1) |
| ||
| Splenic Rupture | Injury, poisoning and procedural complications | MedDRA (8.1) |
| ||
| Suicidal Ideation | Psychiatric disorders | 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) |
| ||
| Tracheal Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) |
| ||
| Trigeminal Neuralgia | Nervous system disorders | MedDRA (8.1) |
| ||
| Urinary Tract Infection | Infections and infestations | MedDRA (8.1) |
| ||
| Urinary Tract Infection Staphylococcal | Infections and infestations | MedDRA (8.1) |
| ||
| Urosepsis | Infections and infestations | MedDRA (8.1) |
| ||
| Varicose Vein Ruptured | Vascular disorders | MedDRA (8.1) |
| ||
| Volvulus of Bowel | Gastrointestinal disorders | MedDRA (8.1) |
| ||
| Vulvar Dysplasia | Renal and urinary disorders | MedDRA (8.1) |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adverse Drug Reaction | General disorders | MedDRA (8.1) |
| ||
| Anxiety | Psychiatric 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 Cholesterol Increased | Investigations | MedDRA (8.1) |
| ||
| Cellulitis | Infections and infestations | MedDRA (8.1) |
| ||
| Constipation | Gastrointestinal disorders | MedDRA (8.1) |
| ||
| Contusion | Injury, poisoning and procedural complications | MedDRA (8.1) |
| ||
| Cystitis | Infections and infestations | MedDRA (8.1) |
| ||
| Depression | Psychiatric disorders | MedDRA (8.1) |
| ||
| Diarrhoea | Gastrointestinal disorders | MedDRA (8.1) |
| ||
| Dizziness | Nervous system disorders | MedDRA (8.1) |
| ||
| Fall | Injury, poisoning and procedural complications | MedDRA (8.1) |
| ||
| Fatigue | General disorders | MedDRA (8.1) |
| ||
| Headache | Nervous system disorders | MedDRA (8.1) |
| ||
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (8.1) |
| ||
| Hypoaesthesia | Nervous system disorders | MedDRA (8.1) |
| ||
| Influenza | Infections and infestations | MedDRA (8.1) |
| ||
| Insomnia | Psychiatric disorders | MedDRA (8.1) |
| ||
| Mobility Decreased | Musculoskeletal and connective tissue disorders | MedDRA (8.1) |
| ||
| Multiple Sclerosis | Nervous system 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 | General disorders | MedDRA (8.1) |
| ||
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA (8.1) |
| ||
| Paraesthesia | Nervous system disorders | MedDRA (8.1) |
| ||
| Pollakiuria | Renal and urinary disorders | MedDRA (8.1) |
| ||
| Pyrexia | General 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) |
| ||
| Tremor | Nervous system disorders | MedDRA (8.1) |
| ||
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (8.1) |
| ||
| Urinary Incontinence | Renal and urinary disorders | MedDRA (8.1) |
| ||
| Urinary Tract Infection | Infections and infestations | MedDRA (8.1) |
| ||
| Vomiting | Gastrointestinal disorders | MedDRA (8.1) |
| ||
| White Blood Cell Count Increased | Investigations |
| |||
| White Blood Cells Urine Positive | Investigations |
|
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 |
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|
| Patients Withdrawn due to AE |
|
| Patients who Died |
|
| Maximum Severity /Patients with Any Mild TEAE |
|
| Maximum Severity /Patients with Any Moderate TEAE |
|
| Maximum Severity /Patients with Any Severe TEAE |
|
|
| (N=242) >8-16 Weeks |
|
| (N=249) >16-42 Weeks |
|
| (N=222) >42-68 Weeks |
|
| (N=204) >68-94 Weeks |
|
| (N=190) >94-120 Weeks |
|
| (N=177) >120-146 Weeks |
|
| (N=156) >146-172 Weeks |
|
| (N=143) >172-198 Weeks |
|
| (N=137) >198-224 Weeks |
|
| (N=58) >224-250 Weeks |
|
| (N=7) >250-276 Weeks |
|
|
|
|