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

January 11, 2017 updated by: Bioprojet

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: Placebo
placebo
Drug: Placebo
EXPERIMENTAL: Pitolisant (BF2.649)
Histamine H3 receptor H3R antagonist/ inverse agonist
Drug: Pitolisant (BF2.649)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Monthly Heavy Drinking Days (HDD/month)
Time Frame: Change from Baseline of Monthly Heavy Drinking Days and at week 24
Change from Baseline of Monthly Heavy Drinking Days and at week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Total daily Alcohol Consumption (TAC)
Time Frame: at week 24 versus Baseline
at week 24 versus Baseline
Percent of Abstinent Days during 24 weeks medication phase (PAD)
Time Frame: at week 24 versus Baseline
at week 24 versus Baseline
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
at baseline , at week 4 , at week 8, at week 12, at week 16, at week 20 and at week 24. versus Baseline
Continuous Abstinence Duration during 24 weeks medication phase (CAD)
Time Frame: at week 24 versus Baseline
at week 24 versus Baseline
Obsessive Compulsive Drinking Scale (OCDC)
Time Frame: at week 24 versus Baseline
at week 24 versus Baseline
Time Line Follow Back (TLFB)
Time Frame: at week 24 versus Baseline
at week 24 versus Baseline
Alcohol Use Disorders Identification Test (AUDIT)
Time Frame: at week 24 versus Baseline
at week 24 versus Baseline
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: at week 24 versus Baseline
at week 24 versus Baseline
Quality of Life (SF-12)
Time Frame: at week 24 versus Baseline
at week 24 versus Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bioprojet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2016

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 7, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 15, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P15-14/BF2.649

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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