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

• Status: Active, not recruiting
• Trial end date: 2022-01-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kinnov Therapeutics
• Collaborator: ECSOR
• Treatments: Cyproheptadine; Prazosin

Criteria

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