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A Trial Evaluating Pitolisant (BF2.649) in Alcohol Use Disorder Treatment

NCT02800083 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2017-01-12

No results posted yet for this study

Summary

* 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.

Conditions

  • Alcohol Abuse, Nervous System

Interventions

DRUG

Pitolisant (BF2.649)

DRUG

Placebo

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2019-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02800083 on ClinicalTrials.gov