Clinical Outcome of a Patented Pharmaceutical Composition (KT-110) to Treat Alcohol Use Disorder While Avoiding Major Side Effects

Phase 2

Completed

• Conditions: Alcohol Use Disorder
• Interventions: Drug: Cyproheptadine; Drug: Alpress LP

• Registration Number: NCT04108104
• Lead Sponsor: Kinnov Therapeutics

Brief Summary

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.

180 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-25
• Study First Submitted QC: 2019-09-26
• Study First Posted: 2019-09-27
• Study Start: 2019-11-30
• Primary Completion: 2021-10-28
• Study Completion: 2022-01-31
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-12
• Last Update Posted: 2024-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

• Severe alcohol use disorder
• High-risk alcohol consumption

Exclusion Criteria

• Patient with orthostatic hypotension
• Patient with hypotension
• History of uncontrolled hypertension
• Patient at risk for urinary retention associated with urethroprostatic disorders
• Patient with a clinically-active malignancy
• Patient with a confirmed cirrhosis
• History of bronchial asthma
• History of uncontrolled hyperthyroidism
• History of cardiovascular disease not under control
• Severe psychiatric disorder
• History of alcohol withdrawal syndrome

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-dose group	Alpress LP	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)
Low-dose group	Alpress LP	Periactine® (Cyproheptadine 8 mg/day; two times 4 mg: morning and evening) and Alpress® (5 mg once a day slow-release: evening administration).
Placebo group	Alpress LP	Placebo of Periactine® (three times per day: morning, noon and evening) and placebo of Alpress® (once a day: evening)
Low-dose group	Cyproheptadine	Periactine® (Cyproheptadine 8 mg/day; two times 4 mg: morning and evening) and Alpress® (5 mg once a day slow-release: evening administration).
High-dose group	Cyproheptadine	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)
Placebo group	Cyproheptadine	Placebo of Periactine® (three times per day: morning, noon and evening) and placebo of Alpress® (once a day: evening)

Primary Outcome Measures

Name	Time	Method
Change in the mean quantity of alcohol consumed per day in the three groups	weeks 9 to 12

Trial Locations

Locations (35)

Association Hospitalière de Bourgogne Franche-Comté; 🇫🇷 Saint-Rémy, France

Cabinet Médical; 🇫🇷 Bersée, France

HIA Clermont Tonnerre; 🇫🇷 Brest, France

Centre d'Addictologie "Pierre-Fouquet" - CHD La Candélie; 🇫🇷 Agen, France

clinique de la Bréhonnière; 🇫🇷 Astillé, France

Centre de Soins, d'Accompagnement et de Prévention en addictologie Bizia; 🇫🇷 Bayonne, France

CHRU Brest - Hôpital Cavale Blanche; 🇫🇷 Brest, France

Service Universitaire d'Addictologie de Lyon - Centre Hospitalier Le Vinatier; 🇫🇷 Bron, France

CHU Provences-Alpes Côte d'Azur Hôpital Publique; 🇫🇷 Marseille, France

Centre Hospitalier Sainte-Anne; 🇫🇷 Paris, France

Centre Hospitalier d'Abbeville; 🇫🇷 Abbeville, France

Clinique Saint Barnabé; 🇫🇷 Marseille, France

Centre Hospitalier Régional Universitaire Saint Eloi - Service d'addictologie et complications somatiques; 🇫🇷 Montpellier, France

Centre Hospitalier Universitaire de Nantes - site Hôtel-Dieu; 🇫🇷 Nantes, France

Centre Hospitalier universitaire de Nice - Hôpital Archet II; 🇫🇷 Nice, France

Centre Médico-Psychologique Saint-Marc; 🇫🇷 Orléans, France

Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou - Centre hépato-digestif; 🇫🇷 Rennes, France

cabinet médical du Dr El-Ayoubi; 🇫🇷 Tours, France

Hôpital St-Julien; 🇫🇷 Nancy, France

Hôpital Fernand-Widal; 🇫🇷 Paris, France

Centre Hospitalier de la Côte Basque - Service d'addictologie; 🇫🇷 Bayonne, France

Centre Hospitalier Universitaire de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

Centre Hospitalier Intercommunal de Créteil - Service Hépato-Gastro-entérologie; 🇫🇷 Créteil, France

Centre Hospitalier Universitaire de Dijon - Service d'addictologie; 🇫🇷 Dijon, France

Centre Hospitalier Camille Claudel; 🇫🇷 La Couronne, France

Centre Hospitalier de La Rochelle; 🇫🇷 La Rochelle, France

Centre Hospitalier Emile-Roux; 🇫🇷 Le Puy-en-Velay, France

Centre hospitalier Esquirol - Pôle d'addictologie en Limousin; 🇫🇷 Limoges, France

Centre Hospitalier Universitaire de Lyon - Hôpital de la Croix Rousse; 🇫🇷 Lyon, France

Hôpital Universitaire Carémeau; 🇫🇷 Nîmes, France

Centre Hospitalier Régional d'Orléans - Hôpital La Source - Service d'hépato-gastro-entérologie et oncologie digestive; 🇫🇷 Orléans, France

Centre Hospitalier de Pau - Unité d'addictologie; 🇫🇷 Pau, France

Centre Ambulatoire de Santé Mentale; 🇫🇷 Saint-Martin-d'Hères, France

Centre Hospitalier de Saint-Nazaire; 🇫🇷 Saint-Nazaire, France

Centre Hospitalier Annecy Genevois; 🇫🇷 Épagny, France