Alcohol Abuse, Nervous System Clinical Trial
Official title:
A Multisite Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Pitolisant (BF2.649) For Alcohol Use Disorder Treatment
- 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).
- The Secondary end points will be designed to assess safety and tolerability and to
further investigate the effect of pitolisant on other alcohol use criteria (e.g. total
alcohol consumption, number of abstinence days), craving as well as the improvement in
mental health (depression, sleep) and quality of life.
- Total alcohol consumption (TAC) from baseline to end of treatment. TAC was defined
as mean daily alcohol consumption in g/day over a month (28 days).
- Percent of patients without HDDs during the 24 weeks RT phase of the study.
(Continuous Controlled Drinking=CCD)
- Percent of Abstinent Days during RT phase (PAD)
- Continuous Abstinence Duration from baseline during 24 weeks RT phase (CAD)
- 4-week point prevalence abstinence at end of treatment
- Improvement in alcohol biomarkers (e.g. ALAT, ASAT, % CDT) during 24 week RT phase
- Craving (Obsessive Compulsive Drinking Scale) during 24 week RT phase
- Beck Depression Inventory (BDI) during 24 week RT phase
- Quality of sleep (Pittsburgh Sleep Quality Index) during RT phase.
- Treatment retention during 24 week RT
- Quality of life (SF-12) during RT phase
- Percent patients without HDDs during the OL follow up period
- Quality of life (SF-12) during OL phase
- Quality of sleep (Pittsburgh Sleep Quality Index) during OL phase
- Treatment retention OL 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-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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment