NCT04108104

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: Kinnov Therapeutics · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Alcohol Use Disorder

Interventions

Type	Name	Description
DRUG	Cyproheptadine	3-month treatment
DRUG	Alpress LP	3-month treatment

Timeline

• Start date: 2019-11-30
• Primary completion: 2021-10-28
• Completion: 2022-01-31
• First posted: 2019-09-27
• Last updated: 2024-04-15

Locations

35 sites across 1 country: France