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History of Changes for Study: NCT04108104
Clinical Outcome of a Patented Pharmaceutical Composition (KT-110) to Treat Alcohol Use Disorder While Avoiding Major Side Effects (COCKTAIL)
Latest version (submitted March 1, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 26, 2019 None (earliest Version on record)
2 March 12, 2020 Recruitment Status, Study Status and Contacts/Locations
3 March 16, 2020 Contacts/Locations and Study Status
4 November 5, 2020 Contacts/Locations and Study Status
5 November 6, 2020 Contacts/Locations and Study Status
6 November 10, 2020 Contacts/Locations and Study Status
7 December 1, 2020 Contacts/Locations and Study Status
8 March 1, 2021 Study Status and Contacts/Locations
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Study NCT04108104
Submitted Date:  December 1, 2020 (v7)

Open or close this module Study Identification
Unique Protocol ID: KT-100-001
Brief Title: Clinical Outcome of a Patented Pharmaceutical Composition (KT-110) to Treat Alcohol Use Disorder While Avoiding Major Side Effects (COCKTAIL)
Official Title: 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
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2020
Overall Status: Recruiting
Study Start: November 30, 2019
Primary Completion: February 2021 [Anticipated]
Study Completion: May 2021 [Anticipated]
First Submitted: September 25, 2019
First Submitted that
Met QC Criteria:
September 26, 2019
First Posted: September 27, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
December 1, 2020
Last Update Posted: December 2, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Kinnov Therapeutics
Responsible Party: Sponsor
Collaborators: ECSOR
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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/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).

Detailed Description:
Open or close this module Conditions
Conditions: Alcohol Use Disorder
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 180 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Low-dose group
Periactine® (Cyproheptadine 8 mg/day; two times 4 mg: morning and evening) and Alpress® (5 mg once a day slow-release: evening administration).
Drug: Cyproheptadine
3-month treatment
Other Names:
  • Periactine®
Drug: Alpress LP
3-month treatment
Other Names:
  • Prazosin
Experimental: High-dose group
Periactine® (Cyproheptadine 12 mg/day; three times 4 mg: morning, noon and evening) and Alpress® (10 mg [2 tablets of 5 mg] once a day slow-release: evening administration)
Drug: Cyproheptadine
3-month treatment
Other Names:
  • Periactine®
Drug: Alpress LP
3-month treatment
Other Names:
  • Prazosin
Placebo Comparator: Placebo group
Placebo of Periactine® (three times per day: morning, noon and evening) and placebo of Alpress® (once a day: evening)
Drug: Cyproheptadine
3-month treatment
Other Names:
  • Periactine®
Drug: Alpress LP
3-month treatment
Other Names:
  • Prazosin
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Change in the mean quantity of alcohol consumed per day in the three groups

[Time Frame: weeks 9 to 12]
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: Lucas Biela
Telephone: +33(0)674344966
Email: lb@kinnov-therapeutics.com
Study Officials: Alain Puech
Study Director
Kinnov Therapeutics
Locations: France
Centre Hospitalier Annecy Genevois
[Recruiting]
Épagny, France
Contact:Contact: Guillaume Ouziel, MD 04 50 63 65 39 gouziel@ch-annecygenevois.fr
Centre Hospitalier d'Abbeville
[Recruiting]
Abbeville, France
Contact:Contact: Maroussia Wilquin-Leblanc, MD 03 22 25 53 00 maroussia.wilquin@orange.fr
Centre d'Addictologie "Pierre-Fouquet" - CHD La Candélie
[Recruiting]
Agen, France
Contact:Contact: Olivier Jacquiez, MD 06 60 16 92 59 equipe.elsa47@ch-candelie.fr
Centre de Soins, d'Accompagnement et de Prévention en addictologie Bizia
[Recruiting]
Bayonne, France
Contact:Contact: Jean-Pierre Daulouede, MD 05 59 44 31 00 bizia.mdm@orange.fr
Centre Hospitalier de la Côte Basque - Service d'addictologie
[Recruiting]
Bayonne, France
Contact:Contact: Eliane Herran, MD 06 74 89 26 74 eherran@ch-cotebasque.fr
Service Universitaire d'Addictologie de Lyon - Centre Hospitalier Le Vinatier
[Recruiting]
Bron, France
Contact:Contact: Benjamin Rolland, MD 04 37 91 50 75 benjamin.rolland@ch-le-vinatier.fr
Centre Hospitalier Universitaire de Clermont-Ferrand
[Recruiting]
Clermont-Ferrand, France
Contact:Contact: Georges Brousse, MD 04 73 75 20 72 gbrousse@chu-clermontferrand.fr
Centre Hospitalier Intercommunal de Créteil - Service Hépato-Gastro-entérologie
[Recruiting]
Créteil, France
Contact:Contact: Camille Barrault, MD 01 57 02 27 30 camille.barrault@chicreteil.fr
Centre Hospitalier Universitaire de Dijon - Service d'addictologie
[Recruiting]
Dijon, France
Contact:Contact: Benoît Trojak, MD 06 60 29 93 48 benoit.trojak@chu-dijon.fr
Centre Hospitalier Camille Claudel
[Recruiting]
La Couronne, France
Contact:Contact: Philippe Batel, MD 06 60 93 31 36 philippe.batel@ch-claudel.fr
Centre Hospitalier de La Rochelle
[Recruiting]
La Rochelle, France
Contact:Contact: Patrick Bendimerad, MD 06 61 33 33 43 patrick.bendimerad@ch-larochelle.fr
Centre Hospitalier Emile-Roux
[Recruiting]
Le Puy-en-Velay, France
Contact:Contact: Antoine Gerard, MD 04 71 04 35 82 antoine.gerard@ch-lepuy.fr
Centre hospitalier Esquirol - Pôle d'addictologie en Limousin
[Recruiting]
Limoges, France
Contact:Contact: Philippe Nubukpo, MD 05 55 43 11 56 philippe.nubukpo@ch-esquirol-limoges.fr
Centre Hospitalier Universitaire de Lyon - Hôpital de la Croix Rousse
[Recruiting]
Lyon, France
Contact:Contact: François Bailly, MD 04 26 10 93 58 francois.bailly@chu-lyon.fr
CHU Provences-Alpes Côte d'Azur Hôpital Publique
[Recruiting]
Marseille, France
Contact:Contact: Nicolas Simon, MD 06 33 39 17 65 nicolas.simon@ap-hm.fr
Clinique Saint Barnabé
[Recruiting]
Marseille, France
Contact:Contact: Christophe Cutarella, MD 06 66 91 58 18 cutarellachristophe@yahoo.fr
Centre Hospitalier Régional Universitaire Saint Eloi - Service d'addictologie et complications somatiques
[Recruiting]
Montpellier, France
Contact:Contact: Hélène Donnadieu-Rigole, MD 04 67 33 70 20 h-donnadieu_rigole@chu-montpellier.fr
Hôpital Universitaire Carémeau
[Recruiting]
Nîmes, France
Contact:Contact: Pascal Perney, MD 04 66 68 69 98 pascal.perney@chu-nimes.fr
Hôpital St-Julien
[Recruiting]
Nancy, France
Contact:Contact: Michael Bisch, MD 03 57 80 66 00 michael.bisch@cpn-laxou.com
Centre Hospitalier Universitaire de Nantes - site Hôtel-Dieu
[Recruiting]
Nantes, France
Contact:Contact: Marie Grall-Bronnec, MD 02 40 84 61 16 marie.bronnec@chu-nantes.fr
Centre Hospitalier universitaire de Nice - Hôpital Archet II
[Recruiting]
Nice, France
Contact:Contact: Eve Gelsi, MD 04 92 03 62 32 gelsi.e@chu-nice.fr
Centre Hospitalier Régional d'Orléans - Hôpital La Source - Service d'hépato-gastro-entérologie et oncologie digestive
[Recruiting]
Orléans, France
Contact:Contact: Damien Labarriere, MD 02 38 51 47 04 damien.labarriere@chr-orleans.fr
Centre Médico-Psychologique Saint-Marc
[Recruiting]
Orléans, France
Contact:Contact: Anne-Marie Brieude, MD 02 38 24 55 15 ambrieude@ch-daumezon45.fr
Centre Hospitalier Sainte-Anne
[Recruiting]
Paris, France
Contact:Contact: Xavier Laqueille, MD 01 45 65 89 49 x.laqueille@ghu-paris.fr
Hôpital Fernand-Widal
[Recruiting]
Paris, France
Contact:Contact: Frank Questel, MD 06 12 72 50 56 franck.questel@aphp.fr
Centre Hospitalier de Pau - Unité d'addictologie
[Recruiting]
Pau, France
Contact:Contact: Emmanuel Augeraud, MD 06 86 48 12 52 emmanuel.augeraud@ch-pau.fr
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou - Centre hépato-digestif
[Recruiting]
Rennes, France
Contact:Contact: Romain Moirand, MD 02 99 28 42 98 then 4 and 2 romain.moirand@chu-rennes.fr
Centre Ambulatoire de Santé Mentale
[Recruiting]
Saint-Martin-d'Hères, France
Contact:Contact: Maurice Dematteis, MD 06 21 75 80 32 mdematteis@chu-grenoble.fr
Centre Hospitalier de Saint-Nazaire
[Recruiting]
Saint-Nazaire, France
Contact:Contact: Florence Martinez, MD 02 40 90 76 66 f.martinez@ch-saintnazaire.fr
Association Hospitalière de Bourgogne Franche-Comté
[Recruiting]
Saint-Rémy, France
Contact:Contact: Thibaut Kuhm, MD 03 84 97 24 86 thibaut.kuhm@ahbfc.fr
cabinet médical du Dr El-Ayoubi
[Recruiting]
Tours, France
Contact:Contact: Hussein El-Ayoubi, MD 06 46 22 39 82 h.elayoubi.md@gmail.com
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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