Efficacy and Safety Evaluating Study of Odelepran for the Use in Patient With Alcohol Dependence
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to assess efficacy and safety of the study drug Odelepran, 125
      mg as compared to placebo in the treatment of alcohol dependence in adult outpatients.
    

Detailed description: 
      Patients for this study were recruited in specialized psychiatric and addictology clinical
      sites in Russia and Kazakhstan. Eligible patients were randomly allocated in one of the
      following treatment groups in 1:1 ratio:

        -  The main group was taking the study drug Odelepran, one 125 mg tablet per day;

        -  The comparison group was taking the comparison drug (Placebo) orally, one tablet per
           day.

      Duration of the study treatment period was 24 weeks (starting from the Day 1). Patients were
      keeping a diary to register their drug taking and amount and kind of alcohol beverages
      consumed.

      Patients were not allowed to participate in psychotherapy or take any psychotropic drugs
      except for short-acting benzodiazepines for insomnia. However benzodiazepines were not
      allowed for taking less than 24 before any study visit.

      Patients visited clinical sites regularly as per the Schedule for visits and procedures.
      During the visits to the site the patient's mental state examination with the use of
      psychometric scales was conducted and the study drug was provided.

      Starting at randomization and subsequently at all scheduled visits investigators conducted a
      brief (15 minutes or less) psychotherapeutic intervention (individual counseling) during
      which patients were asked to provide information on aspects of alcohol consumption and
      emotional states experienced while abstaining from alcohol. Such individual counseling was
      aimed to reinforce lifestyle changes, motivate sobriety and enhance protocol adherence. All
      clinical sites performed such counseling in standardized manner in accordance with
      protocol-specific Guideline developed at St. Petersburg Psychoneurological Research Institute
      named after V.M. Bekhterev for the purposes of this study.28 days after the last dose of
      study drug patients were asked to come for a follow up visit to assess adverse events.

      Patients were not paid for participation in the study.

      Assessments of efficacy and safety were performed monthly. Assessments of drinking behavior
      were based on the Time Line Follow-Back (TLFB) method used to provide information of daily
      number of standard drinks. At every visit patients reported about dynamics of drinking
      (frequency and amount of consumed alcohol) since the previous visit.

      For all assessed variables, the baseline was defined as an assessment at the screening visit.
    

Intervention name(s): Odelepan; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablets, 125 mg; Contains the same excipients as Odelepran but it does not contain the active agent. Placebo is identical to Odelepran in terms of drug form and external characteristics (colour, smell, etc). Doses and route of administration are identical to those for Odelepran.
Other intervention name(s): Ondelopran; LY2196044
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All eligible patients were randomized into two groups to receive investigational drug or placebo at ratio 1:1
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: alcohol dependence; abstinence; alcohol abuse; LY2196044; ondelopran