MedTrace Logo

Open-Label Extension Study of DCCR in PWS Followed by Double-Blind, Placebo-Controlled, Randomized Withdrawal Period

NCT03714373 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2024-04-19

No results posted yet for this study

Summary

This is a multi-center, multi-period study with an open-label period followed by a double-blind, placebo-controlled, randomized withdrawal period evaluating the safety and efficacy of DCCR treatment.

Conditions

Interventions

DRUG

DCCR

Once daily oral administration of open-label DCCR tablet(s) during the OLE Period

DRUG

DCCR

Once daily oral administration of double-blind (DCCR) tablet(s) during the RW Period

DRUG

Placebo for DCCR

Once daily oral administration of double-blind (placebo for DCCR) tablet(s) during the RW Period

Sponsors & Collaborators

  • Soleno Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2023-08-17
Completion
2023-08-17
FDA Drug
Yes

Countries

  • United States
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03714373 on ClinicalTrials.gov