Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2026-02-23 @ 9:22 PM
Study NCT ID:
NCT00649792
Status:
COMPLETED
Last Update Posted:
2012-02-28
First Post:
2008-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis Who Participated in the MS-F204 Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015761', 'term': '4-Aminopyridine'}], 'ancestors': [{'id': 'D000631', 'term': 'Aminopyridines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ablight@acorda.com', 'phone': '914-347-4300', 'title': 'Andrew Blight, PhD Chief Scientific Officer', 'phoneExt': '4102', 'organization': 'Acorda Therapeutics, Inc.'}, 'certainAgreement': {'otherDetails': '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Fampridine-SR', 'description': 'Tablets, 10 mg, BID', 'otherNumAtRisk': 214, 'otherNumAffected': 205, 'seriousNumAtRisk': 214, 'seriousNumAffected': 39}], 'otherEvents': [{'term': 'Adverse Drug Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 24, 'numAffected': 18}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 43, 'numAffected': 33}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 30, 'numAffected': 23}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Balance Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 29, 'numAffected': 23}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Blood Creatine Phosphokinase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 40, 'numAffected': 30}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 19, 'numAffected': 14}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 30, 'numAffected': 24}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 182, 'numAffected': 88}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Fatique', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 39, 'numAffected': 37}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 21, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 17, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 18, 'numAffected': 16}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Multiple Sclerosis Relapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 102, 'numAffected': 61}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Muscle Spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Muscle Spasticity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 33, 'numAffected': 29}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Muscular Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 48, 'numAffected': 38}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 25, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 33, 'numAffected': 27}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 43, 'numAffected': 37}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Pain In Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 37, 'numAffected': 29}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 15, 'numAffected': 12}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Shoulder Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Skin Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 39, 'numAffected': 31}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 148, 'numAffected': 75}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (8.1)'}], 'seriousEvents': [{'term': 'Accidental Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Arthritis Infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Bile Duct Stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Carotid Artery Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Clostridium Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Completed Suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Device Related Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Intestinal Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Lower Limb Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Lumbar Puncture Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Multiple Sclerosis Relapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Muscle Spasticity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Orbital Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Otitis Externa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Ovarian Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Prostate Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Spinal Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Suicide Attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Tibia Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Uterine Leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'sourceVocabulary': 'MedDRA (8.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Timed 25-Foot Walk (T25FW)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fampridine-SR', 'description': 'Tablets, 10 mg, BID'}], 'classes': [{'title': '(N=209) >0-8 Weeks', 'categories': [{'measurements': [{'value': '2.60', 'spread': '0.86', 'groupId': 'OG000'}]}]}, {'title': '(N=197) >8-16 Weeks', 'categories': [{'measurements': [{'value': '2.53', 'spread': '0.93', 'groupId': 'OG000'}]}]}, {'title': '(N=201) >16-42 Weeks', 'categories': [{'measurements': [{'value': '2.52', 'spread': '0.96', 'groupId': 'OG000'}]}]}, {'title': '(N=172) >42-68 Weeks', 'categories': [{'measurements': [{'value': '2.46', 'spread': '1.02', 'groupId': 'OG000'}]}]}, {'title': '(N=160) >68-94 Weeks', 'categories': [{'measurements': [{'value': '2.37', 'spread': '1.04', 'groupId': 'OG000'}]}]}, {'title': '(N=151) >94-120 Weeks', 'categories': [{'measurements': [{'value': '2.35', 'spread': '1.10', 'groupId': 'OG000'}]}]}, {'title': '(N=143) >120-146 Weeks', 'categories': [{'measurements': [{'value': '2.27', 'spread': '1.06', 'groupId': 'OG000'}]}]}, {'title': '(N=33) >146-172 Weeks', 'categories': [{'measurements': [{'value': '2.17', 'spread': '1.07', 'groupId': 'OG000'}]}]}, {'title': '(N=2) >172-198 Weeks', 'categories': [{'measurements': [{'value': '1.85', 'spread': '0.56', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 2, 14, 26, continuing every 26 weeks until the Final Visit', 'unitOfMeasure': 'feet/seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. No imputation for missing data'}, {'type': 'SECONDARY', 'title': 'Subject Global Impression (SGI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fampridine-SR', 'description': 'Tablets, 10 mg, BID'}], 'classes': [{'title': '(N=214) >0-8 Weeks', 'categories': [{'measurements': [{'value': '4.67', 'spread': '1.15', 'groupId': 'OG000'}]}]}, {'title': '(N=200) >8-16 Weeks', 'categories': [{'measurements': [{'value': '4.70', 'spread': '1.28', 'groupId': 'OG000'}]}]}, {'title': '(N=199) >16-42 Weeks', 'categories': [{'measurements': [{'value': '4.77', 'spread': '1.29', 'groupId': 'OG000'}]}]}, {'title': '(N=183) >42-68 Weeks', 'categories': [{'measurements': [{'value': '5.04', 'spread': '1.19', 'groupId': 'OG000'}]}]}, {'title': '(N=173) >68-94 Weeks', 'categories': [{'measurements': [{'value': '4.95', 'spread': '1.20', 'groupId': 'OG000'}]}]}, {'title': '(N=167) >94-120 Weeks', 'categories': [{'measurements': [{'value': '4.97', 'spread': '1.27', 'groupId': 'OG000'}]}]}, {'title': '(N=153) >120-146 Weeks', 'categories': [{'measurements': [{'value': '5.15', 'spread': '1.11', 'groupId': 'OG000'}]}]}, {'title': '(N=35) >146-172 Weeks', 'categories': [{'measurements': [{'value': '4.94', 'spread': '1.39', 'groupId': 'OG000'}]}]}, {'title': '(N=2) >172-198 Weeks', 'categories': [{'measurements': [{'value': '5.50', 'spread': '0.71', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Visit 1 and every clinic visit thereafter (other than the follow-up visit)', 'description': '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.', 'unitOfMeasure': '1-7 scale rating', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. No imputation for missing data'}, {'type': 'SECONDARY', 'title': "Clinician's Global Impression (CGI)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fampridine-SR', 'description': 'Tablets, 10 mg, BID'}], 'classes': [{'title': '(N=213) >0-8 Weeks', 'categories': [{'measurements': [{'value': '3.38', 'spread': '0.84', 'groupId': 'OG000'}]}]}, {'title': '(N=202) >8-16 Weeks', 'categories': [{'measurements': [{'value': '3.27', 'spread': '0.90', 'groupId': 'OG000'}]}]}, {'title': '(N=208) >16-42 Weeks', 'categories': [{'measurements': [{'value': '3.48', 'spread': '0.98', 'groupId': 'OG000'}]}]}, {'title': '(N=181) >42-68 Weeks', 'categories': [{'measurements': [{'value': '3.42', 'spread': '0.92', 'groupId': 'OG000'}]}]}, {'title': '(N=172) >68-94 Weeks', 'categories': [{'measurements': [{'value': '3.58', 'spread': '1.14', 'groupId': 'OG000'}]}]}, {'title': '(N=168) >94-120 Weeks', 'categories': [{'measurements': [{'value': '3.66', 'spread': '1.19', 'groupId': 'OG000'}]}]}, {'title': '(N=154) >120-146 Weeks', 'categories': [{'measurements': [{'value': '3.65', 'spread': '1.16', 'groupId': 'OG000'}]}]}, {'title': '(N=35) >146-172 Weeks', 'categories': [{'measurements': [{'value': '3.96', 'spread': '1.17', 'groupId': 'OG000'}]}]}, {'title': '(N=2) >172-198 Weeks', 'categories': [{'measurements': [{'value': '2.50', 'spread': '0.71', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Visit 1 and every clinic visit thereafter', 'description': '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.', 'unitOfMeasure': '1-7 scale rating', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. No imputation for missing data'}, {'type': 'SECONDARY', 'title': 'Expanded Disability Status Scale (EDSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fampridine-SR', 'description': 'Tablets, 10 mg, BID'}], 'classes': [{'title': '(N=213) Baseline', 'categories': [{'measurements': [{'value': '5.64', 'spread': '1.11', 'groupId': 'OG000'}]}]}, {'title': '(N=163) >94-120 Weeks', 'categories': [{'measurements': [{'value': '5.86', 'spread': '1.05', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The Screening Visit, Visit 6, Final Visit or Early Termination Visit (if applicable)', 'description': 'The EDSS was used to grade patient disability on a scale from 0.0 (normal neurological exam) to 10.0 (death)', 'unitOfMeasure': '0-10 rating scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. No imputation for missing data'}, {'type': 'PRIMARY', 'title': 'Summary of Treatment Emergent Adverse Events (TEAE).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fampridine-SR', 'description': 'Tablets, 10 mg, BID'}], 'classes': [{'title': 'Patients with Any TEAE', 'categories': [{'measurements': [{'value': '205', 'groupId': 'OG000'}]}]}, {'title': 'Patients with Any Serious TEAE', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}, {'title': 'Patients with Any Treatment-Related AE', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}]}]}, {'title': 'Patients Withdrawn due to AE', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Patients who Died', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Maximum Severity/Paitents with Any TEAE - Mild', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Maximum Severity/Patients with Any TEAE - Moderate', 'categories': [{'measurements': [{'value': '120', 'groupId': 'OG000'}]}]}, {'title': 'Maximum Severity/Patients with Any TEAE - Severe', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 40 months', 'description': '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.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. No imputation for missing data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fampridine-SR', 'description': 'Tablets, 10 mg, BID'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '214'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '146'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Fampridine-SR', 'description': 'Tablets, 10 mg, BID'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '201', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.0', 'spread': '9.59', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '144', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '70', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '201', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 214}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-24', 'studyFirstSubmitDate': '2008-03-28', 'resultsFirstSubmitDate': '2012-01-25', 'studyFirstSubmitQcDate': '2008-03-28', 'lastUpdatePostDateStruct': {'date': '2012-02-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-01-25', 'studyFirstPostDateStruct': {'date': '2008-04-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Summary of Treatment Emergent Adverse Events (TEAE).', 'timeFrame': 'up to 40 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Timed 25-Foot Walk (T25FW)', 'timeFrame': 'Week 2, 14, 26, continuing every 26 weeks until the Final Visit'}, {'measure': 'Subject Global Impression (SGI)', 'timeFrame': 'Visit 1 and every clinic visit thereafter (other than the follow-up visit)', 'description': '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.'}, {'measure': "Clinician's Global Impression (CGI)", 'timeFrame': 'Visit 1 and every clinic visit thereafter', 'description': '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.'}, {'measure': 'Expanded Disability Status Scale (EDSS)', 'timeFrame': 'The Screening Visit, Visit 6, Final Visit or Early Termination Visit (if applicable)', 'description': 'The EDSS was used to grade patient disability on a scale from 0.0 (normal neurological exam) to 10.0 (death)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['multiple sclerosis', 'MS', 'walking', 'leg strength', 'demyelination'], 'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.acorda.com/clinical.asp', 'label': 'Click here for more information about Fampridine-SR clinical trials'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient must have been previously enrolled in the Acorda Therapeutics MS-F204 study and received either Fampridine-SR or placebo\n* Patient with clinically defined multiple sclerosis (the diagnostic criteria based on: McDonald WI, et al. Recommended Diagnostic Criteria for Multiple Sclerosis: Guidelines from the International Panel on the Diagnosis of Multiple Sclerosis. Annals of Neurology. 2001; 50: 121-127)\n* Patient must be at least 18 years of age. Any patient who is now over the age of 70 must be in good overall health in the judgment of the investigator\n* Patient must be of adequate cognitive function, as judged by the Investigator\n* Patients who are women of childbearing potential must have a negative urine pregnancy test at the screening visit\n\nExclusion Criteria:\n\n* Female patients who are either pregnant or breastfeeding.\n* Women of childbearing potential who are not using a specified birth control method\n* Patients discontinued prematurely from the MS-F204 study\n* Patients with a history of seizures or with evidence of past, or possible epileptiform activity on an EEG\n* Patient with either a clinically significant abnormal ECG or laboratory values at the MS-F204 EXT screening visit\n* Patient with severe renal impairment\n* Patient with angina, uncontrolled hypertension, clinically significant cardiac arrhythmias, or any other clinically significant cardiovascular abnormality, as judged by the Investigator\n* Patient with a known allergy to pyridine-containing substances or any of the inactive ingredients of the Fampridine-SR tablet\n* Patient who has received an investigational drug (other than Fampridine-SR or placebo under MS-F204 study) within 30 days of the MS-F204EXT screening visit or a patient who is scheduled to enroll in an investigational drug trial at any time during this study\n* Patient who has a history of drug or alcohol abuse within the past year'}, 'identificationModule': {'nctId': 'NCT00649792', 'briefTitle': 'Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis Who Participated in the MS-F204 Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Acorda Therapeutics'}, 'officialTitle': 'Phase 3 Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis Who Participated in the MS-F204 Trial', 'orgStudyIdInfo': {'id': 'MS-F204 EXT'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Fampridine-SR', 'type': 'DRUG', 'otherNames': ['4-aminopyridine'], 'description': 'Tablets, 10 mg, BID (twice daily)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "Barrow Neurology Clinic, St. Joseph's Hospital and Medical Center", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85050', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'HOPE Research Institute', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72703', 'city': 'Fayetteville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Neurological Associates', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}, {'zip': '94705', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'Alta Bates Summit Medical Center - Research and Education Institute', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC, Keck School of Medicine Health Care Consultation Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University MS Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Shepherd Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60062', 'city': 'Northbrook', 'state': 'Illinois', 'country': 'United States', 'facility': 'Consultants in Neurology, Ltd.', 'geoPoint': {'lat': 42.12753, 'lon': -87.82895}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University MS Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '40503', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Associates in Neurology, PSC', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Maryland Center for MS', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02421', 'city': 'Lexington', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Lahey Clinic', 'geoPoint': {'lat': 42.44732, 'lon': -71.2245}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University, Department of Neurology', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55422', 'city': 'Golden Valley', 'state': 'Minnesota', 'country': 'United States', 'facility': 'The Schapiro Center for MS', 'geoPoint': {'lat': 45.00969, 'lon': -93.34912}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '59405', 'city': 'Great Falls', 'state': 'Montana', 'country': 'United States', 'facility': 'Advanced Neurology Specialists', 'geoPoint': {'lat': 47.50024, 'lon': -111.30081}}, {'zip': '07103', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'UMDNJ', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '07666', 'city': 'Teaneck', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Gimbel MS Center at Holy Name Hospital', 'geoPoint': {'lat': 40.8976, 'lon': -74.01597}}, {'zip': '14203', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Jacobs Neurological Institute Buffalo General Hospital', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Corinne Goldsmith Dickinson Center for MS', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Multiple Sclerosis Clinical Care Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Stony Brook', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'CMC - 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