An Open-Label Study of DCCR Tablet in Patients With PWS

Soleno Therapeutics

Status and phase: Withdrawn; Phase 3

Conditions: Prader-Willi Syndrome

Treatments: Drug: DCCR

Study type: Interventional

Funder types: Industry

Identifiers

NCT04086810

C603

Details and patient eligibility

About

The primary objective of this study is to monitor the long-term safety of DCCR in PWS patients.

Sex: All

Ages: 4+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

DCCR

Experimental group

Description:

25 - 450 mg DCCR

Treatment:

Drug: DCCR