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

PHASE3CompletedINTERVENTIONAL
Enrollment

115

Participants

Timeline

Start Date

October 1, 2018

Primary Completion Date

August 17, 2023

Study Completion Date

August 17, 2023

Conditions
Prader-Willi Syndrome
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

Trial Locations (28)

11501

NYU Winthrop Hospital, Mineola

20892

National Institutes of Health Hatfield Clinical Research Center, Bethesda

30322

Emory Children's Center, Atlanta

32608

University of Florida Gainesville, Gainesville

37212

Vanderbilt University, Nashville

43205

The Research Institute at Nationwide Children's Hospital, Columbus

44106

University Hospitals Cleveland Medical Center, Cleveland

46202

Indiana University School of Medicine, Indianapolis

48912

Sparrow Clinical Research Institute, Lansing

55102

Children's Minnesota, Saint Paul

66160

Kansas University Medical Center, Kansas City

75231

Research Institute of Dallas, Dallas

80045

Children's Hospital Colorado, Aurora

84108

University of Utah, Salt Lake City

92123

Rady Children's Hospital San Diego, San Diego

92868

University of California, Irvine, Orange

94305

Stanford University, Palo Alto

98105

Seattle Children's Hospital, Seattle

02115

Boston Children's Hospital, Boston

07503

St. Joseph's University Medical Center, Paterson

G51 4TF

The Queen Elizabeth University, Glasgow

HU3 2JZ

Hull and East Yorkshire Hospitals NHS Trust, Hull

B4 6NH

Birmingham Women's and Children's Hospital, Birmingham

CB21 5ER

Fulbourn Hospital, Cambridge

L9 7AL

Aintree University Hospital NHS Foundation Trust, Liverpool

E1 1BB

Royal London Hospital, London

SW10 9NH

Chelsea and Westminster Hospital, London

W12 OHS

Hammersmith Hospital, London

All Listed Sponsors
lead

Soleno Therapeutics, Inc.

INDUSTRY

NCT03714373 - Open-Label Extension Study of DCCR in PWS Followed by Double-Blind, Placebo-Controlled, Randomized Withdrawal Period | Biotech Hunter | Biotech Hunter