Status:

COMPLETED

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

Lead Sponsor:

Kinnov Therapeutics

Collaborating Sponsors:

ECSOR

Conditions:

Alcohol Use Disorder

Eligibility:

All Genders

18-65 years

Phase:

PHASE2

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...

Eligibility Criteria

Inclusion

  • Severe alcohol use disorder
  • High-risk alcohol consumption

Exclusion

  • 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

Key Trial Info

Start Date :

November 30 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 31 2022

Estimated Enrollment :

154 Patients enrolled

Trial Details

Trial ID

NCT04108104

Start Date

November 30 2019

End Date

January 31 2022

Last Update

April 15 2024

Active Locations (35)

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Page 1 of 9 (35 locations)

1

Centre Hospitalier d'Abbeville

Abbeville, France

2

Centre d'Addictologie "Pierre-Fouquet" - CHD La Candélie

Agen, France

3

clinique de la Bréhonnière

Astillé, France

4

Centre de Soins, d'Accompagnement et de Prévention en addictologie Bizia

Bayonne, France

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