Ignite Creation Date:
2025-12-24 @ 3:34 PM
Ignite Modification Date:
2026-01-09 @ 11:15 AM
Study NCT ID:
NCT04726592
Status:
TERMINATED
Last Update Posted:
2025-09-08
First Post:
2021-01-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of CLORazepate for the Treatment of MIGraine Attack in the Emergency Room
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D020326', 'term': 'Migraine without Aura'}, {'id': 'D020325', 'term': 'Migraine with Aura'}, {'id': 'D006261', 'term': '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'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003009', 'term': 'Clorazepate Dipotassium'}, {'id': 'D007660', 'term': 'Ketoprofen'}, {'id': 'D008787', 'term': 'Metoclopramide'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D062366', 'term': 'para-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D002723', 'term': 'Chlorobenzoates'}, {'id': 'D062425', 'term': 'Hydroxybenzoate Ethers'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D010636', 'term': 'Phenols'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 323}}, 'statusModule': {'whyStopped': 'It has been determined that continuing with enrollments in this study is no longer justified due to the lack of significant impact on the expected outcomes.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-01', 'studyFirstSubmitDate': '2021-01-24', 'studyFirstSubmitQcDate': '2021-01-26', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain relief', 'timeFrame': '2 hours', 'description': 'Percentage of patients "pain-relief" 2 hours after administration of the treatment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Migraine', 'Migraine Without Aura', 'Migraine With Aura', 'Headache']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of clorazepate in addition to the usual medication for treating migraine attack in the emergency room', 'detailedDescription': 'Each patient will receive the usual migraine treatment: IV ketoprofen 100 mg and, if he suffers nausea and/or vomiting, additional IV metoclopramide 10 mg.\n\nDepending on randomization assignment, patient will receive additional placebo (standard treatment arm) or additional IV Clorazepate 20 mg (study arm). The central pharmacy will be responsible for preparing the medications, using a double-blind protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age from 18 to 70\n* Patient suffering migraine or probable migraine (diagnosis made by neurologist according to IHCD3)\n* Present migraine attack lasting ≤ 72 hours\n* Headache intensity moderate or severe on the verbal ordinal scale (4 levels: no headache, mild, moderate or severe)\n* Patient requiring parenteral treatment\n* Affiliation to the French Health-care System "sécurité sociale"\n\nExclusion Criteria:\n\n* abnormalities of neurological exam, seizure, fever (≥ 38°C), and/or SBP≥180 and/or DBP≥110 mmHg\n* suspicion of secondary headache\n* inability to understand the consent or scales\n* pregnancy or breast-feeding\n* known respiratory or liver insufficiency\n* acute alcohol consumption or alcoholism\n* myasthenia\n* Patient requiering treatment with sumatriptan SC, particularly in the event of failure of an anti-inflammatory drug at an effective dose taken within 6 hours\n* recent use of benzodiazepines (\\< 24h diazepam, clonazepam, clorazepate ; \\< 6h alprazolam, lorazepam, midazolam)\n* recent use of pain killers (\\< 2h)\n* contraindication to any of the investigational medication\n* contraindication to intravenous access\n* previous participation to this study'}, 'identificationModule': {'nctId': 'NCT04726592', 'acronym': 'CLORMIG', 'briefTitle': 'Efficacy of CLORazepate for the Treatment of MIGraine Attack in the Emergency Room', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Randomized Double Blinded Monocentric Study Evaluating the Efficacy of CLORazepate for the Treatment of MIGraine Attack in the Emergency Room', 'orgStudyIdInfo': {'id': 'P170903J'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control arm', 'description': 'placebo and standard care :\n\n* Placebo IV\n* Ketoprofen 100 mg IV (if nausea-vomiting)\n* Metoclopramide 10 mg IV(if nausea-vomiting)', 'interventionNames': ['Drug: Placebo', 'Drug: Ketoprofen', 'Drug: Metoclopramide']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental arm', 'description': 'clorazepate and standard care :\n\n* Clorazepate 20 mg IV\n* Ketoprofen 100 mg IV (if nausea-vomiting)\n* Metoclopramide 10 mg IV(if nausea-vomiting)', 'interventionNames': ['Drug: Clorazepate Dipotassium', 'Drug: Ketoprofen', 'Drug: Metoclopramide']}], 'interventions': [{'name': 'Clorazepate Dipotassium', 'type': 'DRUG', 'otherNames': ['TRANXENE'], 'description': 'Clorazepate Dipotassium : 20 mg intravenous injection', 'armGroupLabels': ['Experimental arm']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo IV', 'armGroupLabels': ['Control arm']}, {'name': 'Ketoprofen', 'type': 'DRUG', 'description': 'Ketoprofen 100 mg IV', 'armGroupLabels': ['Control arm', 'Experimental arm']}, {'name': 'Metoclopramide', 'type': 'DRUG', 'description': 'Metoclopramide 10 mg IV', 'armGroupLabels': ['Control arm', 'Experimental arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75010', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Hôpital Lariboisière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}