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

Primary Purpose

Alcohol Abuse, Nervous System

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Pitolisant (BF2.649)
Placebo
Sponsored by
Bioprojet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Abuse, Nervous System

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female with moderate or severe DSM-5 alcohol use disorder (based on the alcohol use disorders section of the MINI Plus)
  • Ages 18-65.
  • Low to moderate alcohol withdrawal symptoms: CIWA-Ar scale <10 at baseline assessment
  • Normal weight: 18 kg/m2 ≤ BMI ≤ 35 kg/m2.
  • Excessive alcohol use: number of heavy drinking days (≥ 60 g/day in men and ≥ 40 g/d in women) ≥15 during 30 days prior to screening and ≥7 during the 2 weeks between screening and baseline.
  • Treatment-seeking, treatment goal: reduced drinking or abstinence
  • If fertile, both males and females must agree to use effective birth control. Females of child-bearing potential must use a medically accepted effective method of birth control, agree to continue this method for the duration of the study and be negative to serum pregnancy test performed at the screening visit. Females should not be breast-feeding.
  • Adequate social support according to the investigator to comply with the study requirements described in the protocol (e.g. transportation to and from trial site, self-rating scales, drug compliance, scheduled visits, etc.).
  • Voluntarily expressed willingness to participate in the study, understanding protocol procedures and having signed and dated an informed consent prior to the start of protocol required procedures while not intoxicated (BAC<0.05).
  • Willing to receive psychosocial support

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, endocrinological 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Pitolisant (BF2.649)

    Placebo

    Arm Description

    Histamine H3 receptor H3R antagonist/ inverse agonist

    placebo

    Outcomes

    Primary Outcome Measures

    Monthly Heavy Drinking Days (HDD/month)

    Secondary Outcome Measures

    Total daily Alcohol Consumption (TAC)
    Percent of Abstinent Days during 24 weeks medication phase (PAD)
    Improvement in alcohol biomarkers (ALAT, ASAT, % CDT)
    Continuous Abstinence Duration during 24 weeks medication phase (CAD)
    Obsessive Compulsive Drinking Scale (OCDC)
    Time Line Follow Back (TLFB)
    Alcohol Use Disorders Identification Test (AUDIT)
    Pittsburgh Sleep Quality Index (PSQI)
    Quality of Life (SF-12)

    Full Information

    First Posted
    June 7, 2016
    Last Updated
    January 11, 2017
    Sponsor
    Bioprojet
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02800083
    Brief Title
    A Trial Evaluating Pitolisant (BF2.649) in Alcohol Use Disorder Treatment
    Acronym
    PoC Alcohol
    Official Title
    A Multisite Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Pitolisant (BF2.649) For Alcohol Use Disorder Treatment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Sponsor decision
    Study Start Date
    October 2016 (undefined)
    Primary Completion Date
    December 2019 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Bioprojet

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alcohol Abuse, Nervous System

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Pitolisant (BF2.649)
    Arm Type
    Experimental
    Arm Description
    Histamine H3 receptor H3R antagonist/ inverse agonist
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Pitolisant (BF2.649)
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    Monthly Heavy Drinking Days (HDD/month)
    Time Frame
    Change from Baseline of Monthly Heavy Drinking Days and at week 24
    Secondary Outcome Measure Information:
    Title
    Total daily Alcohol Consumption (TAC)
    Time Frame
    at week 24 versus Baseline
    Title
    Percent of Abstinent Days during 24 weeks medication phase (PAD)
    Time Frame
    at week 24 versus Baseline
    Title
    Improvement in alcohol biomarkers (ALAT, ASAT, % CDT)
    Time Frame
    at baseline , at week 4 , at week 8, at week 12, at week 16, at week 20 and at week 24. versus Baseline
    Title
    Continuous Abstinence Duration during 24 weeks medication phase (CAD)
    Time Frame
    at week 24 versus Baseline
    Title
    Obsessive Compulsive Drinking Scale (OCDC)
    Time Frame
    at week 24 versus Baseline
    Title
    Time Line Follow Back (TLFB)
    Time Frame
    at week 24 versus Baseline
    Title
    Alcohol Use Disorders Identification Test (AUDIT)
    Time Frame
    at week 24 versus Baseline
    Title
    Pittsburgh Sleep Quality Index (PSQI)
    Time Frame
    at week 24 versus Baseline
    Title
    Quality of Life (SF-12)
    Time Frame
    at week 24 versus Baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female with moderate or severe DSM-5 alcohol use disorder (based on the alcohol use disorders section of the MINI Plus) Ages 18-65. Low to moderate alcohol withdrawal symptoms: CIWA-Ar scale <10 at baseline assessment Normal weight: 18 kg/m2 ≤ BMI ≤ 35 kg/m2. Excessive alcohol use: number of heavy drinking days (≥ 60 g/day in men and ≥ 40 g/d in women) ≥15 during 30 days prior to screening and ≥7 during the 2 weeks between screening and baseline. Treatment-seeking, treatment goal: reduced drinking or abstinence If fertile, both males and females must agree to use effective birth control. Females of child-bearing potential must use a medically accepted effective method of birth control, agree to continue this method for the duration of the study and be negative to serum pregnancy test performed at the screening visit. Females should not be breast-feeding. Adequate social support according to the investigator to comply with the study requirements described in the protocol (e.g. transportation to and from trial site, self-rating scales, drug compliance, scheduled visits, etc.). Voluntarily expressed willingness to participate in the study, understanding protocol procedures and having signed and dated an informed consent prior to the start of protocol required procedures while not intoxicated (BAC<0.05). Willing to receive psychosocial support 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, endocrinological 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.

    12. IPD Sharing Statement

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

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