Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2026-01-04 @ 3:47 PM
Study NCT ID:
NCT00315666
Status:
COMPLETED
Last Update Posted:
2009-02-20
First Post:
2006-04-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prophylactic Effect of Memantine in Chronic Tension-Type Headache
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018781', 'term': 'Tension-Type Headache'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008559', 'term': 'Memantine'}], 'ancestors': [{'id': 'D000547', 'term': 'Amantadine'}, {'id': 'D000218', 'term': 'Adamantane'}, {'id': 'D001952', 'term': 'Bridged-Ring Compounds'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-19', 'studyFirstSubmitDate': '2006-04-18', 'studyFirstSubmitQcDate': '2006-04-18', 'lastUpdatePostDateStruct': {'date': '2009-02-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Headache duration'}, {'measure': 'Headache intensity'}], 'secondaryOutcomes': [{'measure': 'Headache frequency'}, {'measure': 'The use of simple analgesics'}, {'measure': 'Side effects'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chronic tension-type headache'], 'conditions': ['Tension-Type Headache']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test whether memantine has a prophylactic effect on chronic tension-type headaches.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic tension-type headache\n* Normal urine pH\n\nExclusion Criteria:\n\n* More than 1 migraine attack/month\n* Other major illnesses\n* Overuse of medicine/alcohol\n* Women not using AC\n* Pregnant/breast-feeding women\n* Allergy to memantine'}, 'identificationModule': {'nctId': 'NCT00315666', 'briefTitle': 'Prophylactic Effect of Memantine in Chronic Tension-Type Headache', 'organization': {'class': 'OTHER', 'fullName': 'Danish Headache Center'}, 'officialTitle': 'Prophylactic Effect of Memantine in Chronic Tension-Type Headache', 'orgStudyIdInfo': {'id': '2006-000060-82'}, 'secondaryIdInfos': [{'id': 'KA-20060021'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'memantine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-2600', 'city': 'Glostrup Municipality', 'country': 'Denmark', 'facility': 'Danish Headaches Center', 'geoPoint': {'lat': 55.6666, 'lon': 12.40377}}], 'overallOfficials': [{'name': 'Lars Bendtsen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Danish Headaches Center, Dept. of Neurology, KAS Glostrup, DK-2600 Glostrup'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danish Headache Center', 'class': 'OTHER'}}}}