Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2025-12-25 @ 8:22 PM
Study NCT ID:
NCT00219869
Status:
UNKNOWN
Last Update Posted:
2005-09-22
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Galantamine in the Treatment of Post-Traumatic Headache
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051298', 'term': 'Post-Traumatic Headache'}, {'id': 'D016489', 'term': 'Head Injuries, Closed'}, {'id': 'D008569', 'term': 'Memory Disorders'}, {'id': 'D006261', 'term': 'Headache'}], 'ancestors': [{'id': 'D051271', 'term': 'Headache Disorders, Secondary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D014949', 'term': 'Wounds, Nonpenetrating'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005702', 'term': 'Galantamine'}], 'ancestors': [{'id': 'D047151', 'term': 'Amaryllidaceae Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-09', 'completionDateStruct': {'date': '2005-08'}, 'lastUpdateSubmitDate': '2005-09-13', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Headache Efficacy Measure; number of pain free days after 3 months'}], 'secondaryOutcomes': [{'measure': 'Consumption of rescue medication'}, {'measure': 'Number of days with moderate or severe headache after 3 months.'}]}, 'conditionsModule': {'keywords': ['Post', 'Traumatic', 'Headache', 'Cognitive'], 'conditions': ['Post-Traumatic Headache', 'Head Trauma,Closed', 'Retention Disorders,Cognitive']}, 'descriptionModule': {'briefSummary': 'Most patients with CPTH present with additional major cognitive, behavioral and somatic problems. Most drugs used currently have a negative influence on cognition. Therefore, treatment strategies addressing both the headache and cognitive disturbances in patients with CPTH are necessary. (CPTH; Chronic Post Traumatic Headache).', 'detailedDescription': 'Headache is the most common symptom after a closed head injury, persisting for more then 2 months in 60% of the patients. CPTH is an important cause of consultations in neurology offices and headache clinics, posing a severe burden and affecting the quality of life of sufferers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge range 18-75 CPTH according to ICHD-2 Fertile woman using adequate birth control Willing and able to give informed consent Willing and able to complete the entire course of the study to comply with study instructions Stable does of preventive medication\n\n\\-\n\nExclusion Criteria:\n\nSubject is pregnant or lactating Significant medical or psychiatric disease Previous failure to 4 or more adequate trials of preventive medication Patient on non-stable dose of medication used to prevent CPTH\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00219869', 'briefTitle': 'Galantamine in the Treatment of Post-Traumatic Headache', 'organization': {'class': 'INDIV', 'fullName': 'Rapoport, Alan, M.D.'}, 'officialTitle': 'Galantamine in the Preventive Treatment of Chronic Post-Traumatic Headache', 'orgStudyIdInfo': {'id': 'GAL-EMR-4006'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Galantamine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06902', 'city': 'Stamford', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lori Flanagan, RN', 'role': 'CONTACT', 'email': 'lc@nech.net', 'phone': '203-322-2748'}, {'name': 'Kathy Diomede', 'role': 'CONTACT', 'email': 'kd@nech.net', 'phone': '203-322-2748'}, {'name': 'Alan Rapoport, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Stewart Tepper, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Fred Sheftell, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marcelo Bigal, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The New England Center for Headache', 'geoPoint': {'lat': 41.05343, 'lon': -73.53873}}], 'centralContacts': [{'name': 'Lori L Flanagan, RN', 'role': 'CONTACT', 'email': 'lc@nech.net', 'phone': '203-322-2748'}, {'name': 'Kathy Diomede, RN', 'role': 'CONTACT', 'email': 'kd@nech.net', 'phone': '203-322-2748'}], 'overallOfficials': [{'name': 'Alan Rapoport, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The New England Center for Headache'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rapoport, Alan, M.D.', 'class': 'INDIV'}, 'collaborators': [{'name': 'Ortho-McNeil Neurologics, Inc.', 'class': 'INDUSTRY'}]}}}