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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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