Patients with moderate to severe alcohol use disorder MedDRA version: 19.0 Level: PT Classification code 10001584 Term: Alcohol abuse System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: Wakix
Product Name: Pitolisant
Product Code: BF2.649
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Pitolisant
CAS Number: 903576-44-3
Current Sponsor code: BF2.649
Other des
Sponsors
BIPROJET PHARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female with moderate or severe DSM-5 alcohol use disorder (based on the alcohol use disorders section of the MINI Plus) 2. Ages 18-65. 3. Low to moderate alcohol withdrawal symptoms: CIWA-Ar scale =65 years) no F.1.3.1 Number of subjects for this age range ;Inclusion criteria: 1. Male or female with moderate or severe DSM-5 alcohol use disorder (based on the alcohol use disorders section of the MINI Plus) 2. Ages 18-65. 3. Low to moderate alcohol withdrawal symptoms: CIWA-Ar scale =65 years) no F.1.3.1 Number of subjects for this age range ;Inclusion criteria: 1. Male or female with moderate or severe DSM-5 alcohol use disorder (based on the alcohol use disorders section of the MINI Plus) 2. Ages 18-65. 3. 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 2. Clinical depression or suicidality: Beck Depression Inventory (BDI) 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). 5. History of serious head trauma or injury causing loss of consciousness that lasted more than 3 minutes. 6. HIV positive; HCV positive; HBsAg positive, 7. History of psychosis, or current severe psychiatric disorder, e.g. schizophrenia, bipolar disorder, severe depression or organic brain syndrome unrelated to alcohol abuse 8. Physical dependence on sedatives or hypnotics that requires pharmacologically supported detox. 9. Receiving ongoing alcohol use disorder medication (e.g. Baclofen) 10. 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. 11. Known history of syncope, arrhythmia, myocardial infarction or any known significant ECG abnormality 12. Known hypersensitivity to the tested treatment including active substance and excipients. 13. Participation in clinical trial and receipt of investigational drug(s) during previous 60 days, except as explicitly approved by the Principal Investigator. 14. Insufficient medical insurance according to local regulations. 15. Pregnant woman or a pregnancy detected with a positive serum pregnancy test performed at the screening visit or lactating women 16. Male subject who wants to conceive a child during the duration of the study. ;Exclusion criteria: . History of delirium tremens, epilepsy, or withdrawal seizures 2. Clinical depression or suicidality: Beck Depression Inventory (BDI) 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). 5. History of serious head trauma or injury causing loss of consciousness that lasted more than 3 minutes. 6. HIV positive; HCV positive; HBsAg positive, 7. History of psychosis, or current severe psychiatric disorder, e.g. schizophrenia, bipolar disorder, severe depression or organic brain syndrome unrelated to alcohol abuse 8. Physical dependence on sedatives or hypnotics that requires pharmacologically supported detox. 9. Receiving ongoing alcohol use disorder medication (e.g. Baclofen) 10. 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. 11. Known history of syncope, arrhythmia, myocardial infarction or any known significant ECG abnormality 12. Known hypersensitivity to the tested treatment including active substance and excipients. 13. Participation in clinical trial and receipt of investigational drug(s) during previous 60 days, except as explicitly approved by the Principal Investigator. 14. Insufficient medical insurance according to local regulations. 15. Pregnant woman or a pregnancy detected with a positive serum pregnancy test performed at the screening visit or lactating women 16. Male subject who wants to conceive a child during the duration of the study. ;Exclusion criteria: . History of delirium tremens, epilepsy, or withdrawal seizures 2. Clinical depression or suicidality: Beck Depression Inventory (BDI) 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). 5. History of serious head trauma or injury causing loss of consciousness that lasted more than 3 minutes. 6. HIV positive; HCV positive; HBsAg positive, 7. History of psychosis, or current severe psychiatric disorder, e.g. schizophrenia, bipolar disorder, severe depression or organic brain syndrome unrelated to alcohol abuse 8. Physical dependence on sedatives or hypnotics that requires pharmacologically supported detox. 9. Receiving ongoing alcohol use disorder medication (e.g. Baclofen) 10. 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. 11. Known history of syncope, arrhythmia, myocardial infarction or any known significant ECG abnormality 12. Known hypersensitivity to the tested treatment including active substance and excipients. 13. Participation in clinical trial and receipt of investigational drug(s) during previous 60 days, except as explicitly approved by the Principal Investigator. 14. Insufficient medical insurance according to local regulations. 15. Pregnant woman or a pregnancy detected with a positive serum pregnancy test performed at the screening visit or lactating women 16. Male subject who wants to conceive a child during the duration of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study primary end point is the decrease in the number of monthly heavy drinking days (HDD) (= 60 g/day in men and = 40 g/d in women) from baseline to the end of the double blind Randomized Treatment (RT).;Secondary Objective: - TAC from baseline to the end of treatment. - Percent of patients without HDDs during the 24 weeks medication phase of the study. (CCD) - PAD during 24 weeks medication phase - CAD during 24 weeks medication phase - 4-week point prevalence abstinence at end of treatment - Improvement in alcohol biomarkers (e.g. ALAT, ASAT, % CDT) during 24-week medication phase - Craving (Obsessive Compulsive Drinking Scale) during 24 week medication phase - BDI during 24 week RT phase - Treatment retention during 24 week RT phase - Percent patients without HDDs during the OL follow up period - Safety will be assessed by evaluation of treatment emergent AEs , physical examinations, laboratory tests , potential withdrawal, evaluation scales and physical examination, measurement of HR, BP, and body weight at each study visit )V0-FU5). If at ECG QTcF = 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.;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;Main Objective: The study primary end point is the decrease in the number of monthly heavy drinking days (HDD) (= 60 g/day in men and = 40 g/d in women) from baseline to the end of the double blind Randomized Treatment (RT).;Secondary Objective: - TAC from baseline to the end of treatment. - Percent of patients without HDDs during the 24 weeks medication phase of the study. (CCD) - PAD during 24 weeks medication phase - CAD during 24 weeks medication phase - 4-week point | — |
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 24 weeks medication phase of the study. (Continuous controlled drinking=CCD) · Percent of Abstinent Days during 24 weeks medication phase (PAD) · Continuous Abstinence Duration during 24 weeks medication phase (CAD) · 4-week point prevalence abstinence at end of treatment · Improvement in alcohol biomarkers (e.g. ALAT, ASAT, % CDT) during 24-week medication phase · Craving (Obsessive Compulsive Drinking Scale) during 24 week medication phase · Beck Depression Inventory (BDI) during 24 week RT phase · Treatment retention during 24 week RT phase · Percent patients without HDDs during the OL follow up period · 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-FU5). 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: See Protocol;Secondary end point(s): - Total daily alcohol consumption (TAC) from baseline to the end of treatment. · Percent of patients without HDDs during the 24 weeks medication phase of the study. (Continuous controlled drinking=CCD) · Percent of Abstinent Days during 24 weeks medication phase (PAD) · Continuous Abstinence Duration during 24 weeks medication phase (CAD) · 4-week point prevalence abstinence at end of treatment · Improvement in alcohol biomarkers (e.g. ALAT, ASAT, % CDT) during 24-week medication phase · Craving (Obsessive Compulsive Drinking Scale) during 24 week medication phase · Beck Depression Inventory (BDI) dur | — |
Countries
Bulgaria, Russian Federation
Contacts
Public ContactBioprojet clinical department;Bioprojet clinical department;Bioprojet clinical department ;;
BIOPROJET PHARMA;BIOPROJET PHARMA;BIOPROJET PHARMA
Outcome results
None listed