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

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).

Timeline

Start

2019-11-30

Primary completion

2021-10-28

Completion

2022-01-31

Outcome

Met primary endpoint

paper A significant main treatment effect in the change in TAC was found in the intent-to-treat population (P = 0.039). PMID 38597214 ↗

paper The HDG and LDG showed a benefit in the change in TAC from baseline to month 3 compared with PG: -23.6 g/day, P = 0.016 PMID 38597214 ↗

Publications

• Results 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cyproheptadine	Small molecule	8 mg	—
Subject	Cyproheptadine	Small molecule	12 mg	—
Subject	Prazosin	Unknown	5 mg	—
Subject	Prazosin	Unknown	10 mg	—

Indications