Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT00820105
Status:
TERMINATED
Last Update Posted:
2009-12-24
First Post:
2009-01-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ADX10059 Migraine Prevention Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D004827', 'term': 'Epilepsy'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}}, 'statusModule': {'whyStopped': 'Incidence of abnormalities of liver function tests is higher than expected in this population.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'lastUpdateSubmitDate': '2009-12-23', 'studyFirstSubmitDate': '2009-01-08', 'studyFirstSubmitQcDate': '2009-01-08', 'lastUpdatePostDateStruct': {'date': '2009-12-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of migraine headache days during weeks 9-12 of the treatment period', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Migraine frequency', 'timeFrame': '12 weeks'}, {'measure': 'Migraine severity', 'timeFrame': '12 weeks'}, {'measure': 'Migraine duration', 'timeFrame': '12 weeks'}, {'measure': 'Occurrence of aura', 'timeFrame': '12 weeks'}, {'measure': 'Functional impairment severity', 'timeFrame': '12 weeks'}, {'measure': 'Rescue medication use', 'timeFrame': '12 weeks'}, {'measure': 'Proportion of responders', 'timeFrame': '12 weeks'}, {'measure': 'Global assessment of study medication', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Migraine', 'Aura', 'Migraine headache'], 'conditions': ['Migraine']}, 'descriptionModule': {'briefSummary': 'Evaluation of ADX10059 to prevent migraine attacks'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients aged 18 to 65 years\n* History of migraine\n* Aged ≤ 50 years at onset of migraine history\n\nExclusion Criteria:\n\n* Cluster headache or chronic migraine headaches\n* Currently uses, or within 3 months of Screening, has used: sodium valproate or topiramate and any other drugs used specifically for migraine prophylaxis, for example beta-blockers, calcium channel blockers, tricyclic antidepressants, selective serotonin reuptake inhibitors\n* Unable to distinguish migraine headache from tension and other types of headache\n* Current history of psychiatric disorder requiring regular medication\n* Known history of alcohol abuse\n* Known clinically significant allergy or known hypersensitivity to drugs\n* History of a significant medical condition that may affect the safety of the patient or preclude adequate participation in the study\n* Pregnant or breast-feeding'}, 'identificationModule': {'nctId': 'NCT00820105', 'briefTitle': 'ADX10059 Migraine Prevention Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Addex Pharma S.A.'}, 'officialTitle': 'A Phase 2B, Randomised, Double-blind, Placebo-controlled, Parallel Group, Dose-ranging, Multicentre Study to Investigate the Efficacy, Safety and Tolerability of the mGluR5 Negative Allosteric Modulator ADX10059 for the Prevention of Migraine', 'orgStudyIdInfo': {'id': 'ADX10059-206'}, 'secondaryIdInfos': [{'id': '2008-005481-30'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ADX10059 25 mg', 'description': 'Weeks 1-2: once daily Weeks 3-12: twice daily', 'interventionNames': ['Drug: ADX10059']}, {'type': 'EXPERIMENTAL', 'label': 'ADX10059 50 mg', 'description': 'Weeks 1-2: once daily Weeks 3-12: twice daily', 'interventionNames': ['Drug: ADX10059']}, {'type': 'EXPERIMENTAL', 'label': 'ADX10059 100 mg', 'description': 'Weeks 1-2: once daily Weeks 3-12: twice daily', 'interventionNames': ['Drug: ADX10059']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'ADX10059 Matching Placebo', 'description': 'Weeks 1-2: once daily Weeks 3-12: twice daily', 'interventionNames': ['Drug: ADX10059 Matching Placebo']}], 'interventions': [{'name': 'ADX10059', 'type': 'DRUG', 'description': 'oral administration', 'armGroupLabels': ['ADX10059 25 mg']}, {'name': 'ADX10059', 'type': 'DRUG', 'description': 'Oral administration', 'armGroupLabels': ['ADX10059 50 mg']}, {'name': 'ADX10059', 'type': 'DRUG', 'description': 'Oral administration', 'armGroupLabels': ['ADX10059 100 mg']}, {'name': 'ADX10059 Matching Placebo', 'type': 'DRUG', 'description': 'Oral administration', 'armGroupLabels': ['ADX10059 Matching Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vienna', 'country': 'Austria', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Liège', 'country': 'Belgium', 'facility': 'Liège', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'city': 'Sint-Truiden', 'country': 'Belgium', 'facility': 'Sint-Truiden', 'geoPoint': {'lat': 50.81679, 'lon': 5.18647}}, {'city': 'Wilrijk', 'country': 'Belgium', 'facility': 'Wilrijk', 'geoPoint': {'lat': 51.16734, 'lon': 4.39513}}, {'city': 'Lille', 'country': 'France', 'facility': 'Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Nice', 'country': 'France', 'facility': 'Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'city': 'Paris', 'country': 'France', 'facility': 'Paris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Berlin', 'country': 'Germany', 'facility': '06', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Berlin Hellersdorf 11', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Bochum', 'country': 'Germany', 'facility': 'Bochum', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'city': 'Dresden', 'country': 'Germany', 'facility': 'Dreseden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'city': 'Essen', 'country': 'Germany', 'facility': '02', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'city': 'Essen', 'country': 'Germany', 'facility': '28', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Frankfurt', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Freiburg', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'city': 'Göppingen', 'country': 'Germany', 'facility': 'Göppingen', 'geoPoint': {'lat': 48.70354, 'lon': 9.65209}}, {'city': 'Görlitz', 'country': 'Germany', 'facility': 'Görlitz', 'geoPoint': {'lat': 51.15518, 'lon': 14.98853}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'Hamburg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Itzehoe', 'country': 'Germany', 'facility': 'Itzehoe', 'geoPoint': {'lat': 53.92099, 'lon': 9.51529}}, {'city': 'Leipzig', 'country': 'Germany', 'facility': 'Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'city': 'Magdeburg', 'country': 'Germany', 'facility': 'Magdeburg', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'city': 'München', 'country': 'Germany', 'facility': '05', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'München', 'country': 'Germany', 'facility': '10', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'Münster', 'country': 'Germany', 'facility': 'Münster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'city': 'Wiesbaden', 'country': 'Germany', 'facility': 'Wiesbaden', 'geoPoint': {'lat': 50.08601, 'lon': 8.24435}}, {'city': 'Berkshire', 'country': 'United Kingdom', 'facility': 'Berkshire'}, {'city': 'Cardiff', 'country': 'United Kingdom', 'facility': 'Cardiff', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'city': 'Liverpool', 'country': 'United Kingdom', 'facility': 'Liverpool', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'city': 'London', 'country': 'United Kingdom', 'facility': '24', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Manchester', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Addex Pharma S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Study Director', 'oldOrganization': 'Addex Pharma SA'}}}}