Efficacy and Safety of Circadin® in the Treatment of Sleep Disturbances in Children With Neurodevelopment Disabilities

PHASE3CompletedINTERVENTIONAL
Enrollment

125

Participants

Timeline

Start Date

October 31, 2013

Primary Completion Date

March 27, 2018

Study Completion Date

March 27, 2018

Conditions
Sleep Disorders
Interventions
DRUG

Circadin 2/5/10 mg

Circadin 2/5/10 mg. Active arm

DRUG

Placebo

Control arm

Trial Locations (28)

17822

Geinsinger Clinic, Danville

21205

Kennedy Krieger Institute, Baltimore

32763

Lake Mary Pediatrics, Orange City

Ericksen Research & Development, Clinton

33014

Crystal BioMedical Research, LLC, Miami Lakes

33408

Mate Lazlo, West Palm Beach

37240

Vanderbilt University, Nashville

60563

AMR Baber research INC, Naperville

75115

INSITE Clinical Research, DeSoto

77090

Red Oak Psychiatry Associates, Houston

78229

Sleep Therapy & Research Center, San Antonio

78258

Road Runner Research, Ltd, San Antonio

85006

Southwest Autism Research and Resource Center (SARRC), Phoenix

89052

Child Neurology Specialists/ CRCN, Henderson

98011

Pacific institute of medical science, Bothell

30080-6315

Attalla Consultants LLC, dba Institue for Behabiovral medicine, Smyrna

08043

Clinical research center of New Jersey, LLC, Voorhees Township

19104-4399

The children's hospital of Philadelphia, Philadelphia

Unknown

Helsinki Sleep Clinic Vitalmed OY, Helsinki

Hospital Raymond Poincare, Garches

Strasbourg University Hospital Depatment of Child Psychiatry & Neurology, Strasbourg

Yulius Mental Health Organization, Dordrecht

Hospital Gelderse Vallei, Ede

University Medical Center Groningen, Groningen

Birmingham Childrens Hospital NHS FOUNDATION TRUST, Birmingham

Blackpool Victoria Teaching Hospitals NHS Foundation Trust, Blackpool

Guy's & St. Thomas's NHS Foundation Trust of St Thomas's Hospital, London

University Hospital Southampton NHS Foundation Trust, Southampton

Sponsors
All Listed Sponsors
lead

Neurim Pharmaceuticals Ltd.

INDUSTRY

NCT01906866 - Efficacy and Safety of Circadin® in the Treatment of Sleep Disturbances in Children With Neurodevelopment Disabilities | Biotech Hunter | Biotech Hunter