An Open-Label Study of DCCR Tablet in Patients With PWS
Summary
The primary objective of this study is to monitor the long-term safety of DCCR in PWS patients.
Timeline
- Start
- 2019-10
- Primary completion
- 2019-10
- Completion
- 2019-10
Outcome
Met primary endpoint
Stopped: “Study was never initiated; rather the duration of open-label study C602 (NCT03714373) was extended.”
release “The primary endpoint, change in hyperphagia using HQ-CT, and all key secondary endpoints showed significant improvements in DCCR treated subjects compared with placebo” soleno.life ↗
release “Key Top -line Results of Study C602 Hyperphagia: The mean (SE) improvement in hyperphagia, the primary endpoint in the DESTINY PWS study, represented by a decrease in the HQ-CT total score, of -9.9 (0.77), was highly significant (p<0.0001)” soleno.life ↗
release “Announced positive statistically significant top-line data from the randomized withdrawal period of Study C602, a long-term treatment study of DCCR” soleno.life ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DCCR | Unknown | 25 mg | Oral |
| Subject | DCCR | Unknown | 450 mg | Oral |