Pilot Study on BP1.4979 Effect on Binge Eating Disorders

Binge-Eating Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05118906
• Other study ID #: P20-08 / BP1.4979
• Secondary ID: 2021-000472-11
• Status: Recruiting
• Phase: Phase 2
• Start date: March 7, 2022
• Est. completion date: March 2025

Study information

• Verified date: April 2024
• Source: Bioprojet
• Contact: Patricia Rodriguez, PhD
• Phone: +33147036633
• Email: p.rodriguez[@]bioprojet.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Binge-Eating Disorder
• Bulimia
• Feeding and Eating Disorders

Intervention

Drug:
• BP1.4979 active drug
2 tablets 15 mg of BP1.4979 per day
• Placebo
2 tablets of placebo per day

Locations

Country	Name	City	State
France	Nutrition Department, La Pitié Salpêtrière Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Bioprojet

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety assessed by AEs collection	Safety of BP1.4979 based on AEs reporting during the treatment period.	8 weeks
Primary	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	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
Secondary	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