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

Phase 3WithdrawnNCT04086810

Soleno Therapeutics, Inc.

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Prader-Willi Syndrome

Interventions

DCCRDRUG

Once daily oral administration

Eligibility

Sex: ALLMin age: 4 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Adverse Events (Safety)

Assess the safety of DCCR by evaluating the incidence and severity of adverse events reported.

Time frame: Baseline to Week 106

Data from ClinicalTrials.gov

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