Pilot Study on BP1.4979 Effect on Binge Eating Disorders

Study Overview
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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.

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.

Official Title
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A Double-blind, Placebo-controlled Pilot Trial of BP1.4979 for the Treatment of Binge Eating Disorder

Conditions
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Binge-Eating Disorder

Intervention / Treatment
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* Drug: BP1.4979 active drug
* Drug: Placebo


Participation Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BP1.4979<br>15 mg BID active treatment | Drug: BP1.4979 active drug<br>* 2 tablets 15 mg of BP1.4979 per day<br>* Other names: BP1.4979;|
| Placebo Comparator: Placebo<br>matching placebo | Drug: Placebo<br>* 2 tablets of placebo per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binge Eating episodes per week | Number of Binge Eating episodes per week as measured during baseline and at the end of the treatment period | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binge Eating days per week | Number of Binge Eating days per week as measured during baseline and at the end of the treatment period | 8 weeks | 
| Quality of Life improvement (CGI-I) | Quality of life as per assessment on the Clinical Global Improvement (CGI-I) scale measured at randomization and at the end of the treatment period. The CGI is a 7-point scale that requires the clinician to assessment of the patient's illness at the beginning of the intervention (Baseline state) and rated as: 1, Normal, not at all ill; 2, Borderline mentally ill; 3, Mildly ill; 4, Moderately ill; 5, Markedly ill; 6, Severely ill; 7, Among the most extremely ill patients. The Clinical Global Impression-Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. | 8 weeks |