Pilot Study on BP1.4979 Effect on Binge Eating Disorders

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-07

Study Completion Date

2025-08-21

Brief Summary

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This pilot study is to assess the efficacy and safety of BP1.4979 15 mg BID in female patients with moderate to severe binge eating disorder (BED), as defined according to DSM-5 guidelines.

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Detailed Description

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First clinical study to assess the effect of the BP1.4979 on BED in female patients over an 8 week-tretament period.

Conditions

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Binge-Eating Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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BP1.4979

15 mg BID active treatment

Group Type EXPERIMENTAL

BP1.4979 active drug

Intervention Type DRUG

2 tablets 15 mg of BP1.4979 per day

Placebo

matching placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

2 tablets of placebo per day

Interventions

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BP1.4979 active drug

2 tablets 15 mg of BP1.4979 per day

Intervention Type DRUG

Placebo

2 tablets of placebo per day

Intervention Type DRUG

Other Intervention Names

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BP1.4979

Eligibility Criteria

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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
* BMI \< 50 kg/m2.

Exclusion Criteria

* Current diagnosis of bulimia nervosa or anorexia nervosa.
* History of bariatric surgery.
* 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. barrier protection; 3. contraceptive implantation system; 4. oral contraceptive pills; 5. surgically sterile patient; and 6. abstinence. All participants should have a negative pregnancy test prior to randomization
* Ongoing alcohol or tobacco addiction treatment (except Nicotine Replacement Therapy \[NRT\] with at least one-month stable dose prior to screening visit).

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No