Prader-Willi Syndrome
Conditions
Keywords
PWS, Prader-Willi Syndrome
Brief summary
The primary objective of this study is to monitor the long-term safety of DCCR in PWS patients.
Interventions
DRUGDCCR
Once daily oral administration
Sponsors
Soleno Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Successful completion of clinical study C602, Visit 15 * Provide voluntary, written informed consent (parent(s) / legal guardian(s) of subject); provide voluntary, written assent (subject, as appropriate) * Primary caregiver must be able to communicate with Investigator and study site personnel as well as read and complete the study-required questionnaires.
Exclusion criteria
* Positive urine pregnancy test (in females of childbearing potential) * Females who are pregnant or breastfeeding, and/or plan to become pregnant or to breast-feed during or within 90 days after study participation * Any new disease, condition, or circumstance, which may significantly impact subject safety
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events (Safety) | Baseline to Week 106 | Assess the safety of DCCR by evaluating the incidence and severity of adverse events reported. |
Outcome results
None listed