Male or female with moderate or severe DSM-5 alcohol use disorder (based on the alcohol use disorders section of MINI) MedDRA version: 20.0 Level: LLT Classification code 10001590 Term: Alcohol addiction System Organ Class: 100000024510
Conditions
Sponsors
BIOPROJET PHARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female with moderate or severe DSM-5 alcohol use disorder (based on the alcohol use disorders section of MINI) - Ages 18-65 - Low to moderate alcohol withdrawal symptoms: CIWA-Ar scale =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - History of delirium tremens, epilepsy, or withdrawal seizures - Clinical depression or suicidality: Beck Depression Inventory (BDI) = 16 and suicidality (Item G ?0) - Recent illicit drug use, i.e. cannabis, cocaine, amphetamines or opioids. - Clinically significant cardiovascular, hematologic, severe hepatic impairment or FLTs > 3 ULN, renal > (Stage 2 and 3 according to international classification of renal kidney disease), neurological, endocrine abnormalities or abnormal clinical laboratory results (in most cases > 3ULN). - History of serious head trauma or injury causing loss of consciousness that lasted more than 3 minutes. - HIV positive; HCV positive; HBsAg positive, - History of psychosis, or current severe psychiatric disorder, e.g. schizophrenia, bipolar disorder, severe depression or organic brain syndrome unrelated to alcohol abuse - Physical dependence on sedatives or hypnotics that requires pharmacologically supported detox. - Receiving ongoing alcohol use disorder medication (e.g. Baclofen) - Other active clinically significant illness, which could interfere with the study conduct or counter-indicate the study treatments or place the patient at risk during the trial or compromise the study participation. - Known history of syncope, arrhythmia, myocardial infarction or any known significant ECG abnormality - Known hypersensitivity to the tested treatment including active substance and excipients. - Participation in clinical trial and receipt of investigational drug(s) during previous 60 days, except as explicitly approved by the Principal Investigator. - Insufficient medical insurance according to local regulations. - Pregnant woman or a pregnancy detected with a positive serum pregnancy test performed at the screening visit or lactating women - Male subject who wants to conceive a child during the duration of the study and for 21 days after study completion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess tolerance and efficacy of 12 weeks BP1.3656 at 30µg OD vs 60 µg OD versus placebo to reduce alcohol consumption in alcohol dependent patients;Secondary Objective: Not applicable;Primary end point(s): Decrease in number of monthly heavy drinking days (HDD/month) (= 60 g/day in men and = 40 g/d in women) from baseline to the end of the double blind Randomized Treatment (RT).;Timepoint(s) of evaluation of this end point: Evaluation of alcohol consumption performed at each visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Total daily alcohol consumption (TAC) from baseline to the end of treatment. - Percent of patients without HDDs during the 12 weeks medication phase of the study. (Continuous controlled drinking=CCD) - Percent of Abstinent Days during 12 weeks medication phase (PAD) - Continuous Abstinence Duration during 12 weeks medication phase (CAD) - 4-week point prevalence abstinence at end of treatment - Improvement in alcohol biomarkers (e.g. ALAT, ASAT, % CDT) during 12-week medication phase - Craving (Obsessive Compulsive Drinking Scale) during 12 week medication phase - Beck Depression Inventory (BDI) during 12 week RT phase - Treatment retention during 12 week RT phase - Safety will be assessed by evaluation of treatment emergent adverse events (TEAE), physical examinations, clinical laboratory tests (blood chemistry, hematology, and urinalysis), subsequent end of treatment potential withdrawal, evaluation scales and physical examination, measurement of heart rate, blood pressure, and body weight at each study visit )V0-V7). If at ECG Fridericia’s corrected QT interval = 500 ms or if difference to baseline is = 60 ms it will be required to check ECG by second measurement after lying down 10 minutes.;Timepoint(s) of evaluation of this end point: According to the protocol | — |
Countries
Bulgaria, France, Netherlands, Russian Federation
Contacts
Public ContactClinical Development
BIOPROJET PHARMA
Outcome results
None listed