An Open-Label Study of DCCR Tablet in Patients With PWS
Phase 3
Withdrawn
- Conditions
- Prader-Willi Syndrome
- Interventions
- Drug: DCCR
- Registration Number
- NCT04086810
- Lead Sponsor
- Soleno Therapeutics, Inc.
- Brief Summary
The primary objective of this study is to monitor the long-term safety of DCCR in PWS patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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.
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DCCR DCCR 25 - 450 mg DCCR
- Primary Outcome Measures
Name Time Method Adverse Events (Safety) Baseline to Week 106 Assess the safety of DCCR by evaluating the incidence and severity of adverse events reported.
- Secondary Outcome Measures
Name Time Method