Binge-Eating Disorder
Conditions
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.
Interventions
DRUGBP1.4979 active drug
2 tablets 15 mg of BP1.4979 per day
DRUGPlacebo
2 tablets of placebo per day
Sponsors
Bioprojet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Safety assessed by AEs collection | 8 weeks | Safety of BP1.4979 based on AEs reporting during the treatment period. |
Countries
France
Outcome results
None listed