A double-blind, placebo-controlled pilot trial of BP1.4979 for the treatment of binge eating disorder. - P20-08 / BP1.4979

Bioprojet Pharma0 sites86 target enrollmentAugust 24, 2023

ConditionsBinge eating disorder MedDRA version: 21.1Level: PTClassification code: 10004716Term: Binge eating Class: 100000004873 Therapeutic area: Psychiatry and Psychology [F] - Behavior and Behavior Mechanisms [F01]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Binge eating disorder
Sponsor: Bioprojet Pharma
Enrollment: 86
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 24, 2023

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Bioprojet Pharma

Eligibility Criteria

Inclusion Criteria

•Patient must voluntarily express a willingness to participate in this study, sign and date an informed consent prior to beginning any protocol required procedures., Female aged between 18 and 65 years, inclusive., Diagnosis of BED according to DSM\-5 criteria., At least two binge\-eating days per week and at least 8 episodes during the 2 weeks prior to initiation of study medication, prospectively documented in take\-home binge diaries., BMI \< 50 kg/m2\., In the opinion of the investigator, the patient has adequate support to comply with the entire study requirements as described in the protocol (e.g.,transportation to and from trial site, ability to understand and fill in the self\-rating scales, drug compliance, availability to attend to the scheduled visits, full understanding of the protocol etc..).

Exclusion Criteria

•Patient with a current diagnosis of bulimia nervosa or anorexia nervosa., Use of psychostimulants to facilitate fasting or dieting as a part of the eating disorder within the past 6 months, misuse of psychostimulants within the past 6 months, or positive drug screen for psychostimulants at the screening visit., History (within the past year) of psychosis, severe mania or hypomania, or dementia or any other active clinically significant illness or any psychiatric disorder that might interfere with a diagnostic assessment, treatment, or study compliance., Ongoing alcohol or tobacco addiction treatment (except Nicotine Replacement Therapy \[NRT] with at least one\-month stable dose prior to screening visit)., Patient who is pregnant, lactating, or of childbearing potential who is not using adequate contraceptive measures. The following are considered adequate methods of birth control: 1\. intrauterine device (IUD); 2\. contraceptive implantation system; 3\. oral contraceptive pills; 4\. surgically sterile patient; and 5\. abstinence. Women are considered not to have childbearing potential before their menarche, at least 2 years after menopause (no menses) or if they have had a permanent sterilization that includes hysterectomy, bilateral salpingectomy and bilateral oophorectomy. All participants should have a negative pregnancy test prior to randomization. Birth control methods must be in place for the total duration of the study and until the end of exposure to the study treatment (i.e., 5 half\-lives of the study drug corresponding to 4 days after last dose of BP1\.4979\)., Uncontrolled hypertension (\>160/100 mmHg)., Known history of long QTc syndrome or presenting on ECG: \- a QTcF interval strictly higher than 450 ms (electrocardiogram Fridericia’s corrected QT interval \= QT / 3v \[60/HR]), \- or any significant abnormality (e.g., within the last 3 months prior to screening: myocardial infarction, significant arrhythmias or conduction abnormalities) which in the opinion of the physician investigator precludes study participation., Prior (within 30 days or 5 half\-lives prior to screening visit, whichever is longer) or current therapy with any psychotropic medications including monoamine oxidase inhibitors (MAOIs) antidepressants, antipsychotics, antiepileptics, dopamine antagonist antiemetics, dopamine agonists, mood stabilizers, or psychostimulants, GLP\-1 receptor agonists, long\-acting benzodiazepines and therapy with herbal preparations and over\-the\-counter medications., 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 (or 5 half\-lives, whichever is longer), except as explicitly approved by the Principal Investigator., No health insurance., History of bariatric surgery in the past 5 years before study entry., Clinically unstable and concomitant medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine, or other systemic disease., Concomitant prolactin\-dependent tumors (e.g., pituitary gland prolactinomas or breast cancer)., Severe hepatic impairment or liver function tests (AST, ALT) \> 3 ULN, renal impairment, or abnormal clinical laboratory results (in most cases \> 3 ULN) specifically including hypokalemia., Suicidal ideation as evidenced by positive answer to questions 4 or 5 in the Columbia\-Suicide\-Severity Rating Scale (C\-SSRS) at screening or suicide risk as