Efficacy and Safety Evaluating Study of Odelepran for the Use in Patient With Alcohol Dependence

NCT03663374 | Completed Phase 3

• 1 other identifier: CN07006005
• Study Type: interventional
• Target: 644
• Locations: 2 countries
• Sites: 22

Brief 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.

Conditions

Alcohol Dependence

Keywords

alcohol dependence; abstinence; alcohol abuse; LY2196044; ondelopran

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the mean daily alcohol consumption

  Calculated as total number of drinks in month divided by number of days in month.

  Baseline and Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 of treatment

Secondary Outcomes (15)

• Change in the number of days of abstinence per month as compared to the baseline

  Baseline and Week 24 of treatment

• Change in the percentage of days of heavy drinking per month as compared to the baseline

  Baseline and Week 24 of treatment

• Time to the first day of drinking

  From baseline till the first day of alcohol consumption

• Time to the first day of heavy drinking

  From baseline till the first day of heavy drinking

• Change from baseline in alcohol consumption per drinking day

  Baseline and Week Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 of treatment

Other Outcomes (1)

• Number of hospitalizations due to alcohol intoxication

  6 month prior to the baseline and week 28 of treatment

Study Arms (2)

Odelepan

EXPERIMENTAL

One tablet once daily

Drug: Odelepan

Placebo

PLACEBO COMPARATOR

One tablet once daily

Drug: Placebo

Interventions

Odelepan DRUG

Tablets, 125 mg

Also known as: Ondelopran, LY2196044

Odelepan

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated informed consent.
• Outpatients (not hospitalized by the moment of randomization).
• Average alcohol consumption during 30 days prior to screening higher than a medium drinking risk level (men: \> 4 drinks/day or 14 drinks/week; women \> 3 drinks/day or 7 drinks/week) according to the National Institute on Alcohol Abuse and Alcoholism (NIAAA) criteria.
• Patients diagnosed with alcohol dependence according to the International Classification of Diseases (ICD)-10, assessed with the Mini-International Neuropsychiatric Interview (MINI).
• Abstaining from alcohol during 3 days prior to screening and 3 days before randomization confirmed by the test for alcohol in exhaled air (less than 0,02 %).
• For women retaining childbearing potential - negative pregnancy test and consent to use reliable contraception methods (as well as for men) throughout the study period, including the study follow up period.
• Patients able to comply with study protocol as per investigator's opinion.
• Availability of a patient's trustee who reside with the patient. A trustee is defined here as a person who spends with the patient at least 4 hours a day. The trustee must give his/her consent for participation in the study as the patient's representative.
• Study drug monotherapy must be acceptable for the patient as per investigator's opinion.

You may not qualify if:

• Hypersensitivity to Odelepran or to any excipient of the study drug (including lactose intolerance).
• Binge drinking (more than 5 day consecutive days of heavy drinking) during 30 days prior to screening. Heavy drinking is considered as 5 or more drinks per day for men and 4 or more drinks per day for women.
• Ever diagnosed schizophrenia, schizoaffective disorder, bipolar mood disorder or any other psychiatric disorder, except for alcohol dependence. History of alcohol induced psychosis.
• Anxiety or depressive disorder present at enrollment into the study. Montgomery-Asberg Depression Rating Scale (MADRS) score higher than 15.
• High suicidal risk confirmed by MINI.
• Previous use of opioid antagonists implants less than 3 months prior to screening; use of long-acting naltrexone injections (e,g, Vivitrol) less than 4 weeks after the first injection and 3 months after the second and the following injections; use of cyanamide (Kolme) less than 2 weeks prior to screening, use of oral opioid antagonists or disulfiram during 2 weeks prior to screening.
• Psychotherapeutic "coding" (a method when the patient is induced a misbelief that alcohol consumption would lead to death, expected to result from undisclosed pharmacological manipulation) that took place during less than 3 months prior to screening.
• Use of psychotropic medication less than 3 weeks before the screening (for long-acting and 'depot' formulations) or 1 week before the screening (for other formulations) except for those used to treat alcohol withdrawal syndrome.
• Severe alcohol withdrawal syndrome (severity of alcohol withdrawal more than 10 on Clinical Institute Withdrawal Assessment of Alcohol (CIWA-Ar) scale).
• History of seizures (excepting febrile seizers). Severe brain injury, history of intracranial neoplasms and/or intracranial haemorrhages or any conditions that impose the risk of seizures. History of anticonvulsive therapy.
• Any clinical condition affecting cognitive or other psychoneurological functioning (verified for head injury with the loss of consciousness that lasted more than 1 hour, or resulted in cognitive or behavioral impairment, stroke, encephalopathy, dementia, neurodegenerative disorder, etc). Except for mild cognitive impairment.
• Mental retardation of syndromes of severe organic brain injury.
• Use of drugs of abuse (opioids, cannabinoids, amphetamines, etc.) or diagnoses of substance addiction/dependence at the moment of screening or positive urine drug screen test.
• Significant liver function impairment (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) higher than 3 upper limits of normal range or diagnosis of hepatic failure, class B or C by Child Pugh).
• Severe renal failure (creatinine clearance calculated at the screening less than 30 ml/min or renal replacement therapy).

Sponsors & Collaborators

• R-Pharm: lead
• Synergy Research Inc.: collaborator

Study Sites (22)

Republican Research center of psychiatry, psychotherapy and addictology

Almaty, Kazakhstan

Location

Republican clinical mental hospital n.a. V.M. Bekhterev

Kazan', Russia

Location

First Moscow State Medical University named after I.M.Sechenov

Moscow, Russia

Location

Institute of mental health and addictology, LCC

Moscow, Russia

Location

Murmansk regional narcological dispensary

Murmansk, Russia

Location

Clinical mental hospital #1, Dispensery department

Nizhny Novgorod, Russia

Location

Clinical mental hospital #1,Medico-rehabilitational department

Nizhny Novgorod, Russia

Location

Research center Feniks, LLC

Rostov-on-Don, Russia

Location

Baltic Medicine LLC

Saint Petersburg, Russia

Location

City addiction clinic, 2nd department

Saint Petersburg, Russia

Location

City addiction clinic, Petrogradsky region

Saint Petersburg, Russia

Location

City addiction clinic, Vasileostrovsky region

Saint Petersburg, Russia

Location

Doctor SAN, LLC

Saint Petersburg, Russia

Location

Eco-Safety Research Center

Saint Petersburg, Russia

Location

Pavlov First Saint Petersburg State

Saint Petersburg, Russia

Location

Saint Petersburg regional narcological dispensary

Saint Petersburg, Russia

Location

St.Petersburg V.M. Bekhterev Psychoneurological Research Institute, addictive pathology department

Saint Petersburg, Russia

Location

St.Petersburg V.M. Bekhterev Psychoneurological Research Institute, alcohol dependance department

Saint Petersburg, Russia

Location

Clinical city hospital #2 n.a. V.I. Razumovsky

Saratov, Russia

Location

Mental Health Research Institute

Tomsk, Russia

Location

Lion-Med, LLC

Voronezh, Russia

Location

Yaroslavl Region Clinical Mental Hospital

Yaroslavl, Russia

Location

Related Publications (1)

• Sobell L.C., Sobell M.B. (1992) Timeline Follow-Back. In: Litten R.Z., Allen J.P. (eds) Measuring Alcohol Consumption. Humana Press, Totowa, NJ

  BACKGROUND

MeSH Terms

Conditions

Alcoholism

Interventions

LY2196044

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Mikhail Samsonov

  R-Pharm

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All eligible patients were randomized into two groups to receive investigational drug or placebo at ratio 1:1

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 10, 2018
• Study Start: November 18, 2014
• Primary Completion: April 16, 2016
• Study Completion: May 14, 2016
• Last Updated: May 22, 2019

Record last verified: 2019-05

Locations

KA (1); RU (21)