Pilot Study on BP1.4979 Effect on Binge Eating Disorders
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
First clinical study to assess the effect of the BP1.4979 on BED in female patients over an 8 week-tretament period.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: BP1.4979 15 mg BID active treatment |
Drug: BP1.4979 active drug
2 tablets 15 mg of BP1.4979 per day
Other Names:
|
| Placebo Comparator: Placebo matching placebo |
Drug: Placebo
2 tablets of placebo per day
|
Outcome Measures
Primary Outcome Measures
- Binge Eating episodes per week [8 weeks]
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 [8 weeks]
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) [8 weeks]
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.
Other Outcome Measures
- Safety assessed by AEs collection [8 weeks]
Safety of BP1.4979 based on AEs reporting during the treatment period.
Eligibility Criteria
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
- 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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nutrition Department, La Pitié Salpêtrière Hospital | Paris | France | 75013 |
Sponsors and Collaborators
- Bioprojet
Investigators
- Principal Investigator: Karine Clément, MD, PhD, Nutrition Department, La Pitié Salpêtrière Hospital, Paris
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P20-08 / BP1.4979
- 2021-000472-11