Back to resultsPilot Study on BP1.4979 Effect on Binge Eating Disorders
Primary Purpose
Binge-Eating Disorder
Status
Recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
BP1.4979 active drug
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Binge-Eating Disorder
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
- 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).
Sites / Locations
- Nutrition Department, La Pitié Salpêtrière HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
BP1.4979
Placebo
Arm Description
15 mg BID active treatment
matching placebo
Outcomes
Primary Outcome Measures
Binge Eating episodes per week
Number of Binge Eating episodes per week as measured during baseline and at the end of the treatment period
Secondary Outcome Measures
Binge Eating days per week
Number of Binge Eating days per week as measured during baseline and at the end of the treatment period
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05118906
Brief Title
Pilot Study on BP1.4979 Effect on Binge Eating Disorders
Official Title
A Double-blind, Placebo-controlled Pilot Trial of BP1.4979 for the Treatment of Binge Eating Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 7, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bioprojet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
First clinical study to assess the effect of the BP1.4979 on BED in female patients over an 8 week-tretament period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge-Eating Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BP1.4979
Arm Type
Experimental
Arm Description
15 mg BID active treatment
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
matching placebo
Intervention Type
Drug
Intervention Name(s)
BP1.4979 active drug
Other Intervention Name(s)
BP1.4979
Intervention Description
2 tablets 15 mg of BP1.4979 per day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
2 tablets of placebo per day
Primary Outcome Measure Information:
Title
Binge Eating episodes per week
Description
Number of Binge Eating episodes per week as measured during baseline and at the end of the treatment period
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Binge Eating days per week
Description
Number of Binge Eating days per week as measured during baseline and at the end of the treatment period
Time Frame
8 weeks
Title
Quality of Life improvement (CGI-I)
Description
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.
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Safety assessed by AEs collection
Description
Safety of BP1.4979 based on AEs reporting during the treatment period.
Time Frame
8 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia Rodriguez, PhD
Phone
+33147036633
Email
p.rodriguez@bioprojet.com
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle Lecomte, MD
Phone
+33147036633
Email
i.lecomte@bioprojet.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karine Clément, MD, PhD
Organizational Affiliation
Nutrition Department, La Pitié Salpêtrière Hospital, Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nutrition Department, La Pitié Salpêtrière Hospital
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karine Clément, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Pilot Study on BP1.4979 Effect on Binge Eating Disorders
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