Clinical Trials

NCT IdNCT04108104
TitleClinical Outcome of a Patented Pharmaceutical Composition (KT-110) to Treat Alcohol Use Disorder While Avoiding Major Side Effects
ConditionAlcohol Use Disorder
StudyTypeInterventional
OrganizationKinnov Therapeutics
Sponsor/CollaboratorsKinnov Therapeutics
StatusRecruiting
GenderAll
AgeGroupAdult
Older Adult
Location (with distance)
  • Centre Hospitalier d'Abbeville, Abbeville, France
  • SUAL Le Vinatier, Bron, France
  • CHU Clermont-Ferrand, Clermont-Ferrand, France
  • Hopital Albert Chenevier, Créteil, France
  • CHU de Dijon, Dijon, France
  • CH Camille Claudel, La Couronne, France
  • CH La Rochelle, La Rochelle, France
  • CHU Grenoble - La Tronche, La Tronche, France
  • Centre Psychotherapique de Nancy, Laxou, France
  • Centre Hospitalier Emile-Roux, Le Puy-en-Velay, France
  • Centre hospitalier Esquirol, Limoges, France
  • CHU Lyon Hôpital de la Croix Rousse, Lyon, France
  • CHU Provences-Alpes Côte d'Azur Hôpital Publique, Marseille, France
  • CHU de Nantes - site Hôtel-Dieu, Nantes, France
  • CHU Nice, Nice, France
  • Hôpital Universitaire Carémeau, Nîmes, France
  • CHR Orléans, Orléans, France
  • GHR Sainte-Anne, Paris, France
  • Hôpital Fernand-Widal, Paris, France
  • CHU de Rennes - Pontchaillou, Rennes, France
  • CHU Toulouse - Hôpital Purpan, Toulouse, France
  • Centre Hospitalier Annecy Genevois, Épagny, France
DescriptionDouble-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).