Efficacy and Safety of Tasimelteon Compared With Placebo in Totally Blind Subjects With Non-24-Hour Sleep-Wake Disorder

PHASE3CompletedINTERVENTIONAL
Enrollment

136

Participants

Timeline

Start Date

August 31, 2010

Primary Completion Date

November 30, 2012

Study Completion Date

November 30, 2012

Conditions
Non-24-Hour Sleep-Wake Disorder
Interventions
DRUG

tasimelteon

20 mg tasimelteon capsules, PO daily for 6 months

DRUG

Placebo

Placebo capsules, PO daily for 6 months

Trial Locations (28)

10003

New York Eye and Ear Infirmary, New York

10117

Advanced Sleep Research GmbH, Berlin

15221

Consolidated Clinical trials, Pittsburgh

19118

Center For Sleep Medicine at Chestnut Hill Hospital, Philadelphia

20815

The Center for Sleep and Wake Disorders (Washington, D.C. Metropolitan Area), Chevy Chase

29201

SleepMed, Inc. - Columbia, Columbia

30159

Klinische-Forschung Hannover Mitte, Hanover

30342

Sleep Disorders Center Of Georgia, Atlanta

32174

Ocean Sleep Disorders Center - Ormond Beach, Ormond Beach

33175

Kendall South Medical Center, Inc., Miami

33511

PAB Clinical Research Inc., Brandon

35043

Universitaetsklinikum Glesen and Marburg gmbH/Schlaflabor - Sleep Lab University Marburg, Marburg

43017

Ohio Sleep Medicine Institute (Columbus Metropolitan Area), Dublin

44789

Bergmannsheil University Hospital - Medical Clinic III, Bochum

45246

Tri-State Sleep Disorders Center, Cincinnati

48104

Michigan Head-Pain Neurological Institute, Ann Arbor

60007

Suburban Lung Associates SC (Chicago Metropolitan Area), Elk Grove Village

63017

St. Luke's Sleep Medicine and Research Center (St. Louis Metropolitan Area), Chesterfield

73112

Lynn Health Science Institute, Oklahoma City

77063

Todd J. Swick, M.D., P.A., Houston

80239

Radiant Research - Denver, Denver

80331

Bonomed Studiezentrum, Munich

85006

Pulmonary Associates, PA, Phoenix

90404

St. Johns Sleep Disorder Center - St. Johns Medical Plaza, Santa Monica

92868

SDS Clinical Trials Inc., Orange

94304

VA Palo Alto Health Care System/PAIRE (San Fransisco Bay Area), Palo Alto

97239

Columbia Research Group Inc., Portland

02115

Brigham and Women's Hospital, Boston

Sponsors
All Listed Sponsors
lead

Vanda Pharmaceuticals

INDUSTRY