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The purpose of this study is to evaluate the long-term safety, tolerability and activity of Fampridine-SR in subjects with multiple sclerosis who have previously participated in either an Acorda Therapeutics or an Elan Corporation sponsored protocol. Subjects are eligible regardless of whether they received active drug or placebo during their participation in the previous study.
Under the original protocol, patients were to have their treatment dose titrated upwards from a starting dose of 10mg b.i.d. to 15mg b.i.d. and then to a stable (maintenance) dose of 20mg b.i.d. The protocol was subsequently revised to lower the maximum maintenance dose. In the most current protocol, all patients were down-titrated to 10mg b.i.d. and maintained at this dose for the greater part of the duration of the 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 MS patients over a long period of time.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fampridine-SR b.i.d. (Twice Daily) | Drug | Dosage form - tablets. |
|
| 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. | over 7 years (2004-2011) |
| Measure | Description | Time Frame |
|---|---|---|
| Timed 25 Foot Walk (T25FW) | Screening visit, visit 4, every 12 weeks thereafter, Last Regular Visit, Follow Up Visit and Early Termination Visit | |
| Subject Global Impression (SGI) | The patient was asked to complete a Subject Global Impression (SGI) questionnaire at Visit 1 and every study visit thereafter except the Follow-up visit. This questionnaire asked the patient to rate the effects of the investigational drug on his/her physical well-being during the preceding week, using a 1 to 7 point scale (1 = terrible, 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 b.i.d. (Twice Daily) | All subjects (N=177) received 10mg b.i.d. Tablets. (N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| visit 1 and every clinic visit |
| Clinician Global Impression of Change (CGIC) | The CGIC was based on the Investigator's overall impression of the patient's neurological status and general state of health related to his or her participation in the study, specifically in regard to signs and symptoms associated with MS. Neurological status was rated according to a 1 to 7 point scale (1 = very much improved, 7 = very much worse) | visit 1 and every clinic visit |
| Expanded Disability Status Scale (EDSS) | Based on the baseline neurological exam, each patient was scored according to the Expanded Disability Status Scale, which rates disability on a 0 to 10 scale (0 = normal neurologic examination, 10 = death) *EDSS assessments were not well synchronized to study period because of wide differences in interval between screening and initiation | Screening visit, visit 6 and every 24 months thereafter |
| USC, Keck School of Medicine Health Care Consultation Center |
| Los Angeles |
| California |
| 90033 |
| United States |
| Shepherd Center | Atlanta | Georgia | 30309 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Maryland Center for MS | Baltimore | Maryland | 21201 | 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 |
| 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 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 |
| 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 |
| University of Texas-Houston | Houston | Texas | 77030 | United States |
| MS Center at Evergreen | Kirkland | Washington | 98034 | United States |
| Foothills Medical Center | Calgary | Alberta | T2N 2T9 | Canada |
| St. Michael's Hospital | Toronto | Ontario | M5B 1WB | Canada |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Fampridine-SR b.i.d. (Twice Daily) | All subjects (N=177) received 10mg b.i.d. Tablets. (N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study. |
| 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 | over 7 years (2004-2011) |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Timed 25 Foot Walk (T25FW) | ITT Population. No imputation for missing data | Posted | Mean | Standard Deviation | feet/second | Screening visit, visit 4, every 12 weeks thereafter, Last Regular Visit, Follow Up Visit and Early Termination Visit |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Subject Global Impression (SGI) | The patient was asked to complete a Subject Global Impression (SGI) questionnaire at Visit 1 and every study visit thereafter except the Follow-up visit. This questionnaire asked the patient to rate the effects of the investigational drug on his/her physical well-being during the preceding week, using a 1 to 7 point scale (1 = terrible, 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) | The CGIC was based on the Investigator's overall impression of the patient's neurological status and general state of health related to his or her participation in the study, specifically in regard to signs and symptoms associated with MS. Neurological status was rated according to a 1 to 7 point scale (1 = very much improved, 7 = very much worse) | ITT Population. No imputation for missing data | Posted | Median | Standard Deviation | units on a scale | visit 1 and every clinic visit |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Expanded Disability Status Scale (EDSS) | Based on the baseline neurological exam, each patient was scored according to the Expanded Disability Status Scale, which rates disability on a 0 to 10 scale (0 = normal neurologic examination, 10 = death) *EDSS assessments were not well synchronized to study period because of wide differences in interval between screening and initiation | ITT Population. No imputation for data missing | 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 b.i.d. (Twice Daily) | All subjects (N=177) received 10mg b.i.d. Tablets. (N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study. | 65 | 177 | 176 | 177 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (8.1) |
| ||
| Angina Unstable | Cardiac disorders | MedDRA (8.1) |
| ||
| Aortic Rupture | Vascular disorders | MedDRA (8.1) |
| ||
| Appendicitis Perforated | Gastrointestinal disorders | MedDRA (8.1) |
| ||
| Asthenia | General disorders | MedDRA (8.1) |
| ||
| Atrial Fibrillation | Cardiac disorders | MedDRA (8.1) |
| ||
| Back Injury | Injury, poisoning and procedural complications | MedDRA (8.1) |
| ||
| Bladder Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.1) |
| ||
| Bowen's Disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.1) |
| ||
| Brain Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.1) |
| ||
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.1) |
| ||
| Bronchioloalveolar Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.1) |
| ||
| Calculus Bladder | Renal and urinary disorders | MedDRA (8.1) |
| ||
| Cellulitis | Infections and infestations | MedDRA (8.1) |
| ||
| Cervical Spinal Stenosis | Musculoskeletal and connective tissue disorders | MedDRA (8.1) |
| ||
| Chest Pain | General disorders | MedDRA (8.1) |
| ||
| Cholecystitis | Hepatobiliary disorders | MedDRA (8.1) |
| ||
| Colon Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.1) |
| ||
| Complex Partial Seizures | Nervous system disorders | MedDRA (8.1) |
| ||
| Constipation | Gastrointestinal disorders | MedDRA (8.1) |
| ||
| Convulsion | Nervous system disorders | MedDRA (8.1) |
| ||
| Decubitus Ulcer | Skin and subcutaneous tissue disorders | MedDRA (8.1) |
| ||
| Deep Vein Thrombosis | Vascular disorders | MedDRA (8.1) |
| ||
| Dehydration | Metabolism and nutrition disorders | MedDRA (8.1) |
| ||
| Depressed Level of Consciousness | Nervous system disorders | MedDRA (8.1) |
| ||
| Device Malfunction | Injury, poisoning and procedural complications | MedDRA (8.1) |
| ||
| Dizziness | Nervous system disorders | MedDRA (8.1) |
| ||
| Drug Toxicity | Injury, poisoning and procedural complications | MedDRA (8.1) |
| ||
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) |
| ||
| Encephalopathy | Nervous system disorders | MedDRA (8.1) |
| ||
| Endometriosis | Reproductive system and breast disorders | MedDRA (8.1) |
| ||
| Fall | Injury, poisoning and procedural complications | MedDRA (8.1) |
| ||
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA (8.1) |
| ||
| Haemorrhage | Vascular disorders | MedDRA (8.1) |
| ||
| Haemorrhage Intracranial | Nervous system disorders | MedDRA (8.1) |
| ||
| Hallucination | Psychiatric disorders | MedDRA (8.1) |
| ||
| Hepatic Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.1) |
| ||
| Hip Fracture | Injury, poisoning and procedural complications | MedDRA (8.1) |
| ||
| Hypertension | Vascular disorders | MedDRA (8.1) |
| ||
| Influenza | Infections and infestations | MedDRA (8.1) |
| ||
| Influenza Like Illness | General disorders | MedDRA (8.1) |
| ||
| Kidney Infection | Infections and infestations | MedDRA (8.1) |
| ||
| Limb Injury | Injury, poisoning and procedural complications | MedDRA (8.1) |
| ||
| Lumbar Spinal Stenosis | Musculoskeletal and connective tissue disorders | MedDRA (8.1) |
| ||
| Mania | Psychiatric disorders | MedDRA (8.1) |
| ||
| Mental Status Changes | Psychiatric disorders | MedDRA (8.1) |
| ||
| Multiple Sclerosis | Nervous system disorders | MedDRA (8.1) |
| ||
| Multiple Sclerosis Relapse | Nervous system disorders | MedDRA (8.1) |
| ||
| Muscle Spasticity | Nervous system disorders | MedDRA (8.1) |
| ||
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA (8.1) |
| ||
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA (8.1) |
| ||
| Myocardial Infarction | Cardiac disorders | MedDRA (8.1) |
| ||
| Nephrolithiasis | Renal and urinary disorders | MedDRA (8.1) |
| ||
| Neurogenic Bowel | Gastrointestinal disorders | MedDRA (8.1) |
| ||
| Non-Cardiac Chest Pain | General disorders | MedDRA (8.1) |
| ||
| Oedema Peripheral | General disorders | MedDRA (8.1) |
| ||
| Oesophagitis | Gastrointestinal disorders | MedDRA (8.1) |
| ||
| Orthostatic Hypotension | Vascular disorders | MedDRA (8.1) |
| ||
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (8.1) |
| ||
| Paraparesis | Nervous system disorders | MedDRA (8.1) |
| ||
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) |
| ||
| Pneumonia | Infections and infestations | MedDRA (8.1) |
| ||
| Pneumonia Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) |
| ||
| Postoperative Wound Infection | Infections and infestations | MedDRA (8.1) |
| ||
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.1) |
| ||
| Prostatic Abscess | Infections and infestations | MedDRA (8.1) |
| ||
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) |
| ||
| Pyrexia | General disorders | MedDRA (8.1) |
| ||
| Rectocele | Gastrointestinal disorders | MedDRA (8.1) |
| ||
| Renal Cell Carcinoma Stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.1) |
| ||
| Renal Failure | Renal and urinary disorders | MedDRA (8.1) |
| ||
| Renal Failure Acute | Renal and urinary disorders | MedDRA (8.1) |
| ||
| Respiratory Arrest | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) |
| ||
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) |
| ||
| Rib Fracture | Injury, poisoning and procedural complications | MedDRA (8.1) |
| ||
| Sepsis | Infections and infestations | MedDRA (8.1) |
| ||
| Sinusitis | Infections and infestations | MedDRA (8.1) |
| ||
| Syncope | Nervous system disorders | MedDRA (8.1) |
| ||
| Throat Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.1) |
| ||
| Tibia Fracture | Injury, poisoning and procedural complications | MedDRA (8.1) |
| ||
| Trigeminal Neuralgia | Nervous system disorders | MedDRA (8.1) |
| ||
| Urethral Injury | Injury, poisoning and procedural complications | MedDRA (8.1) |
| ||
| Urinary Tract Infection | Infections and infestations | MedDRA (8.1) |
| ||
| Urosepsis | Infections and infestations | MedDRA (8.1) |
| ||
| Uterine Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.1) |
| ||
| Visual Disturbance | Eye disorders | MedDRA (8.1) |
| ||
| Wound Infection | Infections and infestations | 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) |
| ||
| Blood Creatine Phosphokinase Increased | Investigations | MedDRA (8.1) |
| ||
| Blood Triglycerides Increased | Investigations | MedDRA (8.1) |
| ||
| Bronchitis | Infections and infestations | MedDRA (8.1) |
| ||
| Cataract | Eye disorders | 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) |
| ||
| Dyspepsia | Gastrointestinal disorders | MedDRA (8.1) |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) |
| ||
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (8.1) |
| ||
| Excoriation | Injury, poisoning and procedural complications | MedDRA (8.1) |
| ||
| Fall | Injury, poisoning and procedural complications | MedDRA (8.1) |
| ||
| Fatigue | General disorders | MedDRA (8.1) |
| ||
| Fungal Infection | Infections and infestations | MedDRA (8.1) |
| ||
| Gastroesophageal Reflux Disease | Gastrointestinal disorders | MedDRA (8.1) |
| ||
| Headache | Nervous system disorders | MedDRA (8.1) |
| ||
| Hypertension | Vascular disorders | MedDRA (8.1) |
| ||
| Hypoaesthesia | Nervous system disorders | MedDRA (8.1) |
| ||
| Influenza | Infections and infestations | MedDRA (8.1) |
| ||
| Insomnia | Psychiatric disorders | MedDRA (8.1) |
| ||
| Joint Sprain | Injury, poisoning and procedural complications | MedDRA (8.1) |
| ||
| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA (8.1) |
| ||
| Micturition Urgency | Renal and urinary 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) |
| ||
| Musculoskeletal Stiffness | Musculoskeletal and connective tissue disorders | MedDRA (8.1) |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (8.1) |
| ||
| Nasopharyngitis | Infections and infestations | MedDRA (8.1) |
| ||
| Nausea | Gastrointestinal disorders | MedDRA (8.1) |
| ||
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA (8.1) |
| ||
| Nervousness | Psychiatric disorders | MedDRA (8.1) |
| ||
| Oedema Peripheral | General disorders | MedDRA (8.1) |
| ||
| Osteoporosis | Musculoskeletal and connective tissue 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) |
| ||
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA (8.1) |
| ||
| Pruritus | Skin and subcutaneous 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) |
| ||
| 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 Retention | Renal and urinary disorders | MedDRA (8.1) |
| ||
| Urinary Tract Infection | Infections and infestations | MedDRA (8.1) |
| ||
| Vertigo | Ear and labyrinth disorders | 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 |
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Patients withdrawn due to AE |
|
| Patients who Died |
|
| Maximum Severity/Patients with Any TEAE -Mild |
|
| Maximum Severity/Patients with Any TEAE -Moderate |
|
| Maximum Severity/Patients with Any TEAE -Severe |
|
| Title | Denominators | Categories |
|---|
| (N=153) Baseline |
| |||||
| (N=1) >0-8 Weeks |
| |||||
| (N=134) >8-16 Weeks |
| |||||
| (N=141) >16-42 Weeks |
| |||||
| (N=127) >42-68 Weeks |
| |||||
| (N=111) >68-94 Weeks |
| |||||
| (N=103) >94-120 Weeks |
| |||||
| (N=92) >120-146 Weeks |
| |||||
| (N=86) >146-172 Weeks |
| |||||
| (N=76) >172-198 Weeks |
| |||||
| (N=66) >198-224 Weeks |
| |||||
| (N=56) >224-250 Weeks |
| |||||
| (N=52) >250-276 Weeks |
| |||||
| (N=54) >276-302 Weeks |
| |||||
| (N=50) >302-328 Weeks |
| |||||
| (N=10) >328-354 Weeks |
|
|
|
|