A Multisite Randomized Clinical Trial Evaluating BP1.3656 Versus Placebo For Alcohol Use Disorder Treatment

• Register: EUCTR
• Last refreshed on: 22 January 2018
• Main ID: EUCTR2017-000069-57-NL
• Date of registration: 12/07/2017
• Prospective Registration: Yes
• Primary sponsor: BIOPROJET PHARMA
• Public title: A Multisite Randomized Clinical Trial Evaluating BP1.3656 Versus Placebo For Alcohol Use Disorder Treatment
• Scientific title: A Multisite Randomized Clinical Trial Evaluating BP1.3656 Versus Placebo For Alcohol Use Disorder Treatment - Not applicable
• Date of first enrolment: 12/07/2017
• Target sample size: 129
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-000069-57
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Bulgaria, France, Netherlands, Russian Federation

Contacts

• Name: Clinical Development
• Affiliation: BIOPROJET PHARMA

• Name: Clinical Development
• Affiliation: BIOPROJET PHARMA

Key inclusion & exclusion criteria

Inclusion criteria:
- Male or female with moderate or severe DSM-5 alcohol use disorder (based on the alcohol use disorders section of MINI)
- 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 & = 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 up until 21 days after study completion 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 129
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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, endocrine 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 and for 21 days after study completion.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Not possible to specify

Male or female with moderate or severe DSM-5 alcohol use disorder (based on the alcohol use disorders section of MINI)
MedDRA version: 20.0 Level: LLT Classification code 10001590 Term: Alcohol addiction System Organ Class: 100000024510

Intervention(s)

Product Code: BP1.3656
Pharmaceutical Form: Tablet
INN or Proposed INN: Not Applicable
CAS Number: 914302-59-3
Current Sponsor code: BP1.3656
Other descriptive name: BP1.3656
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Product Code: BP1.3656
Pharmaceutical Form: Tablet
INN or Proposed INN: Not Applicable
CAS Number: 914302-59-3
Current Sponsor code: BP1.3656
Other descriptive name: BP1.3656
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 60-

Primary Outcome(s)

Primary end point(s): Decrease in number of monthly heavy drinking days (HDD/month) (= 60 g/day in men and = 40 g/d in women) from baseline to the end of the double blind Randomized Treatment (RT).

Secondary Objective: Not applicable

Main Objective: To assess tolerance and efficacy of 12 weeks BP1.3656 at 30µg OD vs 60 µg OD versus placebo to reduce alcohol consumption in alcohol dependent patients

Timepoint(s) of evaluation of this end point: Evaluation of alcohol consumption performed at each visit

Secondary Outcome(s)

Secondary end point(s): - Total daily alcohol consumption (TAC) from baseline to the end of treatment.
- Percent of patients without HDDs during the 12 weeks medication phase of the study. (Continuous controlled drinking=CCD)
- Percent of Abstinent Days during 12 weeks medication phase (PAD)
- Continuous Abstinence Duration during 12 weeks medication phase (CAD)
- 4-week point prevalence abstinence at end of treatment
- Improvement in alcohol biomarkers (e.g. ALAT, ASAT, % CDT) during 12-week medication phase
- Craving (Obsessive Compulsive Drinking Scale) during 12 week medication phase
- Beck Depression Inventory (BDI) during 12 week RT phase
- Treatment retention during 12 week RT 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-V7). 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.

Timepoint(s) of evaluation of this end point: According to the protocol

Secondary ID(s)

P15-01

Source(s) of Monetary Support

BIOPROJET PHARMA