Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2026-01-01 @ 3:48 PM
Study NCT ID:
NCT04108104
Status:
COMPLETED
Last Update Posted:
2024-04-15
First Post:
2019-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Outcome of a Patented Pharmaceutical Composition (KT-110) to Treat Alcohol Use Disorder While Avoiding Major Side Effects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003533', 'term': 'Cyproheptadine'}, {'id': 'D011224', 'term': 'Prazosin'}], 'ancestors': [{'id': 'D003986', 'term': 'Dibenzocycloheptenes'}, {'id': 'D001567', 'term': 'Benzocycloheptenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 154}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-12', 'studyFirstSubmitDate': '2019-09-25', 'studyFirstSubmitQcDate': '2019-09-26', 'lastUpdatePostDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the mean quantity of alcohol consumed per day in the three groups', 'timeFrame': 'weeks 9 to 12'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcohol Use Disorder']}, 'referencesModule': {'references': [{'pmid': '38597214', 'type': 'RESULT', 'citation': 'Aubin HJ, Berlin I, Guiraud J, Bruhwyler J, Batel P, Perney P, Trojak B, Bendimerad P, Guillou M, Bisch M, Grall-Bronnec M, Labarriere D, Delsart D, Questel F, Moirand R, Bernard P, Trovero F, Pham HP, Tassin JP, Puech A. Prazosin and cyproheptadine in combination in the treatment of alcohol use disorder: A randomized, double-blind, placebo-controlled trial. Addiction. 2024 Jul;119(7):1211-1223. doi: 10.1111/add.16484. Epub 2024 Apr 10.'}]}, 'descriptionModule': {'briefSummary': 'Double-blind randomised, parallel-group, three-arm, multicentre, placebo-controlled study The primary objective is to demonstrate the superiority of the combination of Periactine® (cyproheptadine 8 mg/day or 12 mg/day) and Alpress® (prazosin 5 mg/day or 10 mg/day) over placebo on the reduction of the total alcohol consumption (TAC), in alcohol-dependent patients.\n\n180 patients will be randomised into the two treatment groups (N=60 in the low-dose group and N=60 in the high-dose group) and the placebo group (N=60).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe alcohol use disorder\n* High-risk alcohol consumption\n\nExclusion Criteria:\n\n* Patient with orthostatic hypotension\n* Patient with hypotension\n* History of uncontrolled hypertension\n* Patient at risk for urinary retention associated with urethroprostatic disorders\n* Patient with a clinically-active malignancy\n* Patient with a confirmed cirrhosis\n* History of bronchial asthma\n* History of uncontrolled hyperthyroidism\n* History of cardiovascular disease not under control\n* Severe psychiatric disorder\n* History of alcohol withdrawal syndrome'}, 'identificationModule': {'nctId': 'NCT04108104', 'acronym': 'COCKTAIL', 'briefTitle': 'Clinical Outcome of a Patented Pharmaceutical Composition (KT-110) to Treat Alcohol Use Disorder While Avoiding Major Side Effects', 'organization': {'class': 'OTHER', 'fullName': 'Greenpharma S.A.S.'}, 'officialTitle': 'Double-blind, Randomised, Parallel-group, Three-arm, Dose Range, Placebo-controlled, Proof-of-concept Study to Evaluate the Efficacy, Tolerability and Safety of a Combination of Cypropheptadine and Prazosin on Alcohol Consumption in Patients With Severe Alcohol Use Disorder', 'orgStudyIdInfo': {'id': 'KT-100-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low-dose group', 'description': 'Periactine® (Cyproheptadine 8 mg/day; two times 4 mg: morning and evening) and Alpress® (5 mg once a day slow-release: evening administration).', 'interventionNames': ['Drug: Cyproheptadine', 'Drug: Alpress LP']}, {'type': 'EXPERIMENTAL', 'label': 'High-dose group', 'description': 'Periactine® (Cyproheptadine 12 mg/day; three times 4 mg: morning, noon and evening) and Alpress® (10 mg \\[2 tablets of 5 mg\\] once a day slow-release: evening administration)', 'interventionNames': ['Drug: Cyproheptadine', 'Drug: Alpress LP']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Placebo of Periactine® (three times per day: morning, noon and evening) and placebo of Alpress® (once a day: evening)', 'interventionNames': ['Drug: Cyproheptadine', 'Drug: Alpress LP']}], 'interventions': [{'name': 'Cyproheptadine', 'type': 'DRUG', 'otherNames': ['Periactine®'], 'description': '3-month treatment', 'armGroupLabels': ['High-dose group', 'Low-dose group', 'Placebo group']}, {'name': 'Alpress LP', 'type': 'DRUG', 'otherNames': ['Prazosin'], 'description': '3-month treatment', 'armGroupLabels': ['High-dose group', 'Low-dose group', 'Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Abbeville', 'country': 'France', 'facility': "Centre Hospitalier d'Abbeville", 'geoPoint': {'lat': 50.10521, 'lon': 1.83547}}, {'city': 'Agen', 'country': 'France', 'facility': 'Centre d\'Addictologie "Pierre-Fouquet" - CHD La Candélie', 'geoPoint': {'lat': 44.20199, 'lon': 0.62055}}, {'city': 'Astillé', 'country': 'France', 'facility': 'clinique de la Bréhonnière', 'geoPoint': {'lat': 47.96282, 'lon': -0.85213}}, {'city': 'Bayonne', 'country': 'France', 'facility': "Centre de Soins, d'Accompagnement et de Prévention en addictologie Bizia", 'geoPoint': {'lat': 43.49316, 'lon': -1.473}}, {'city': 'Bayonne', 'country': 'France', 'facility': "Centre Hospitalier de la Côte Basque - Service d'addictologie", 'geoPoint': {'lat': 43.49316, 'lon': -1.473}}, {'city': 'Bersée', 'country': 'France', 'facility': 'Cabinet Médical', 'geoPoint': {'lat': 50.47978, 'lon': 3.14765}}, {'city': 'Brest', 'country': 'France', 'facility': 'CHRU Brest - Hôpital Cavale Blanche', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'city': 'Brest', 'country': 'France', 'facility': 'HIA Clermont Tonnerre', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'city': 'Bron', 'country': 'France', 'facility': "Service Universitaire d'Addictologie de Lyon - Centre Hospitalier Le Vinatier", 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Créteil', 'country': 'France', 'facility': 'Centre Hospitalier Intercommunal de Créteil - Service Hépato-Gastro-entérologie', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'city': 'Dijon', 'country': 'France', 'facility': "Centre Hospitalier Universitaire de Dijon - Service d'addictologie", 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Épagny', 'country': 'France', 'facility': 'Centre Hospitalier Annecy Genevois', 'geoPoint': {'lat': 45.93584, 'lon': 6.08302}}, {'city': 'La Couronne', 'country': 'France', 'facility': 'Centre Hospitalier Camille Claudel', 'geoPoint': {'lat': 45.61128, 'lon': 0.09948}}, {'city': 'La Rochelle', 'country': 'France', 'facility': 'Centre Hospitalier de La Rochelle', 'geoPoint': {'lat': 46.16308, 'lon': -1.15222}}, {'city': 'Le Puy-en-Velay', 'country': 'France', 'facility': 'Centre Hospitalier Emile-Roux', 'geoPoint': {'lat': 45.04366, 'lon': 3.88523}}, {'city': 'Limoges', 'country': 'France', 'facility': "Centre hospitalier Esquirol - Pôle d'addictologie en Limousin", 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Lyon - Hôpital de la Croix Rousse', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Marseille', 'country': 'France', 'facility': "CHU Provences-Alpes Côte d'Azur Hôpital Publique", 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Marseille', 'country': 'France', 'facility': 'Clinique Saint Barnabé', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Montpellier', 'country': 'France', 'facility': "Centre Hospitalier Régional Universitaire Saint Eloi - Service d'addictologie et complications somatiques", 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Nancy', 'country': 'France', 'facility': 'Hôpital St-Julien', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'city': 'Nantes', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Nantes - site Hôtel-Dieu', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Nice', 'country': 'France', 'facility': 'Centre Hospitalier universitaire de Nice - Hôpital Archet II', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'city': 'Nîmes', 'country': 'France', 'facility': 'Hôpital Universitaire Carémeau', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'city': 'Orléans', 'country': 'France', 'facility': "Centre Hospitalier Régional d'Orléans - Hôpital La Source - Service d'hépato-gastro-entérologie et oncologie digestive", 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'city': 'Orléans', 'country': 'France', 'facility': 'Centre Médico-Psychologique Saint-Marc', 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'city': 'Paris', 'country': 'France', 'facility': 'Centre Hospitalier Sainte-Anne', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Fernand-Widal', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Pau', 'country': 'France', 'facility': "Centre Hospitalier de Pau - Unité d'addictologie", 'geoPoint': {'lat': 43.31117, 'lon': -0.35583}}, {'city': 'Rennes', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou - Centre hépato-digestif', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': "Saint-Martin-d'Hères", 'country': 'France', 'facility': 'Centre Ambulatoire de Santé Mentale', 'geoPoint': {'lat': 45.1787, 'lon': 5.76281}}, {'city': 'Saint-Nazaire', 'country': 'France', 'facility': 'Centre Hospitalier de Saint-Nazaire', 'geoPoint': {'lat': 47.27506, 'lon': -2.2179}}, {'city': 'Saint-Rémy', 'country': 'France', 'facility': 'Association Hospitalière de Bourgogne Franche-Comté', 'geoPoint': {'lat': 46.76334, 'lon': 4.83928}}, {'city': 'Tours', 'country': 'France', 'facility': 'cabinet médical du Dr El-Ayoubi', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'overallOfficials': [{'name': 'Alain Puech', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kinnov Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kinnov Therapeutics', 'class': 'OTHER'}, 'collaborators': [{'name': 'ECSOR', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}