Hyperphagia related behaviour associated with Prader-Willi Syndrome (PWS)
Conditions
Brief summary
Hyperphagia Questionnaire for Clinical Trials (HQ-CT) score - change from Baseline at Week 12
Detailed description
Clinical Global Impression–Severity (CGI-S) for PWS score – change from Baseline at Week 12, Clinical Global Impression–Change (CGI-C) for PWS score at Week 12, Percentage of subjects with treatment response (defined as improvement from Baseline ≥8 points) based on the HQ-CT at Week 12, CGI-S for hyperphagia in PWS score – change from Baseline at Week 12
Interventions
DRUGPlacebo to match carbetocin 11.4 mg/ml (2ml /vial)
Sponsors
Acadia Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hyperphagia Questionnaire for Clinical Trials (HQ-CT) score - change from Baseline at Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Global Impression–Severity (CGI-S) for PWS score – change from Baseline at Week 12, Clinical Global Impression–Change (CGI-C) for PWS score at Week 12, Percentage of subjects with treatment response (defined as improvement from Baseline ≥8 points) based on the HQ-CT at Week 12, CGI-S for hyperphagia in PWS score – change from Baseline at Week 12 | — |
Countries
Belgium, France, Germany, Italy, Spain
Outcome results
None listed