Ignite Creation Date:
2024-05-06 @ 8:43 AM
Last Modification Date:
2024-10-26 @ 12:03 PM
Study NCT ID:
NCT02800083
Status:
WITHDRAWN
Last Update Posted:
2017-01-12
First Post:
2016-06-07
Brief Title:
A Trial Evaluating Pitolisant BF2649 in Alcohol Use Disorder Treatment
Sponsor:
Bioprojet
Organization:
Bioprojet
Study Overview
Official Title:
A Multisite Randomized Double-Blind Placebo-Controlled Trial Evaluating Pitolisant BF2649 For Alcohol Use Disorder Treatment
Status:
WITHDRAWN
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PoC Alcohol
Brief Summary:
The study primary end point is the decrease in the number of monthly heavy drinking days HDD 60 gday in men and 40 gd 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 eg 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 gday over a month 28 days
Percent of patients without HDDs during the 24 weeks RT phase of the study Continuous Controlled DrinkingCCD
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 eg 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 Fridericias 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
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 eg 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 gday over a month 28 days
Percent of patients without HDDs during the 24 weeks RT phase of the study Continuous Controlled DrinkingCCD
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 eg 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 Fridericias 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None