• About Vanda
• Development Pipeline
• 24
• Discovery Research
• Investor Relations

Clinical Trial Information

Vanda Study 3201 is designed to investigate the efficacy and safety of tasimelteon 20 mg versus placebo in totally blind subjects with Non-24-Hour Sleep-Wake Disorder (N24HSWD). Study 3201 is a multicenter, randomized, double-masked, placebo-controlled, parallel study with a target enrollment of 160 individuals. The study includes a 6-month treatment period and an optional open-label extension. Measures of both nighttime and daytime sleep are included, as well as laboratory measures of the synchronization between the internal body clock and the 24-hour environmental light/dark cycle.

Multiple study sites throughout the United States are planned for the study. A list of current study sites is provided below. Additional sites will be added.

The efficacy outcomes to be assessed include average subjective nighttime total sleep time (nTST), average subjective total daytime sleep duration, clinical global impression of change (CGI-C), and urinary 6-sulfatoxymelatonin (aMT6s) assessments. The formal objectives are as follows:

Primary

To determine the efficacy of tasimelteon in improving subjective nighttime total sleep time (nTST) in subjects with N24HSWD as measured by daily Post-Sleep Questionnaires (PSQs).

Secondary

• To determine the efficacy of tasimelteon in reducing total daytime sleep duration in subjects with N24HSWD.
• To assess the potential of tasimelteon to stabilize the phase relationship between the circadian melatonin rhythm and the timing of sleep.
• To assess the effects of tasimelteon as measured by a Clinical Global Impression of Change (CGI-C).
• To assess the potential for withdrawal symptoms after the abrupt discontinuation of tasimelteon during a two week placebo washout period.
• To assess the potential for post-treatment effects immediately (during 3 days) after the abrupt discontinuation of tasimelteon.
• To explore the safety and tolerability of multiple oral doses of tasimelteon.
• To assess the effect of tasimelteon on measures of endocrine function.

Eligibility

Inclusion Criteria:

• Informed written consent;
• 18 years to 75 years;
• No perception of light by the subject's own report;
• Diagnosis of N24HSWD as determined by:
1. History (within the last 3 months) of trouble sleeping at night (such as difficulty initiating sleep or staying asleep), difficulty awakening in the morning, or daytime sleepiness as determined by answering yes to at least one question in the Sleep Complaint Questionnaire and
2. Urinary aMT6s demonstrates a progressive delay of the aMT6 acrophase time.
• Willing and able to comply with study requirements and restrictions including a commitment to a fixed 9-hour sleep opportunity during the study; and
• Fluent in English.

Exclusion Criteria:

• Have a probable diagnosis of a current sleep disorder other than N24HSWD that is the primary cause of the sleep disturbance based on clinical investigator medical judgment;
• Current clinically significant cardiovascular, respiratory, neurologic, hepatic, hematopoietic, renal, gastrointestinal or metabolic dysfunction unless currently controlled and stable;
• History (within the 12 months prior to screening) of psychiatric disorders including Major Depressive Disorder, Generalized Anxiety Disorder, Axis II Disorders, delirium or any other psychiatric disorder that in the opinion of the clinical investigator would affect participation in the study or full compliance with study procedures;
• History of intolerance and/or hypersensitivity to melatonin or melatonin agonists;
• Worked night, rotating, or split (period of work, followed by break, and then return to work) shift work within 1 month of the screening visit or plan to work these shifts during the study;
• Unable to perform calls to the study IVR system to report questionnaire results;
• Exposure to any investigational drug, including placebo, within 30 days or 5 half lives (whichever was longer) of screening;
• Use of central nervous system prescription or OTC medications that affects the sleep-wake cycle; or
• Use of melatonin or melatonin agonist.

Currently Recruiting Sites:

The active sites are listed below. Please continue to check this webpage for additional sites.

United States

Arizona

Pulmonary Associates, PA
Phoenix, Arizona 85006
Dr. Mark Gotfried, principal investigator
Contact Elena Woltz at 602-346-4773

California

VA Palo Alto Health Care System/PAIRE
Palo Alto, California 94304
Dr. Jamie Zeitzer, principal investigator
Contact Karen Bratcher at 650-493-5000 Ext. 64585

SDS Clinical Trials, Inc.
Orange, CA 92868
Dr. Andrew Schreiber, principal investigator
Contact Jane Withrow at 714-834-1565

St. Johns Sleep Disorder Center - St. Johns Medical Plaza
Santa Monica, California 90404
Dr. Daniel Norman, principal investigator
Contact Joe Martinez at 310-586-0843

Colorado

Radiant Research - Denver
Denver, Colorado 80239
Dr. Eugene Du Boff, principal investigator
Contact Recruitment Call Center at 303-477-2273 or Deena Copeland at 303-480-7132 or deenacopeland@radiantresearch.com

Florida

Kendall South Medical Center, Inc.
Miami, Florida 33185
Dr. Roberto Sotolongo, principal investigator
Contact Tania Cary at 305-388-1118

Ocean Sleep Disorders Center - Ormond Beach
Ormond Beach, Florida 32174
Dr. Mandeep Garewal, principal investigator
Contact Sandra Geyer at 386-673-2500

PAB Clinical Research Inc.
Brandon, Florida
Dr. Daniel Lorch, principal investigator
Contact Myra Rodriguez at 813-657-1584 x 229

Georgia

Sleep Disorders Center Of Georgia
Atlanta, Georgia 30342
Dr. Alan Lankford, principal investigator
Contact Felicia Thomas at 404-256-6545 Ext. 209

Illinois

Suburban Lung Associates SC
Elk Grove Village, Illinois 60007
Dr. Robert W. Hart, principal investigator
Contact Ashlyn Jaeger at 847-981-3660 Ext. 288

Maryland

The Center for Sleep and Wake Disorders
Chevy Chase, Maryland 20815
Dr. Helene Emsellem, principal investigator
Contact Kelly Lichty at 301-654-5665 Ext. 2 or research@sleepdoc.com

Massachusetts

Brigham and Women's Hospital
Boston, Massachusetts 02115
Dr. Steven Lockley, principal investigator
Contact Lauren Brogna at 617-525-9872

Michigan

Michigan Head-Pain Neurological Institute
Ann Arbor, Michigan 48104
Dr. James Weintraub, principal investigator
Contact Jennifer Majestic, RN at 734-677-6000 Ext. 4 or jmajestic@mhni.com

Minnesota

Minnesota Regional Sleep Disorder Center
Minneapolis, Minnesota 55415
Contact Dr. Michel Bornemann, principal investigator at 612-873-6288

Missouri

St. Luke's Sleep Medicine and Research Center
Chesterfield, Missouri 63017
Dr. Paula Schweitzer, principal investigator
Contact Elizabeth Forst at 314-205-6939 or elizabeth.forst@stlukes-stl.com

New York

New York Eye and Ear Infirmary
New York, New York 10003
Dr. William Seiple, principal investigator
Contact Alex Yang at 212-979-4024 or ayang@nyee.edu

Ohio

Tri-State Sleep Disorders Center
Cincinnati, Ohio 45246
Dr. Martin Scharf, principal investigator
Contact Krista Solomon at 513-671-3101 or ksolomon@tristatesleep.com

Ohio Sleep Medicine Institute (Columbus Metropolitan Area)
Dublin, Ohio 43017
Dr. Markcus Schmidt, principal investigator
Contact Aaron Shaver at 614-766-0773 or aaron@sleepmedicine.com

Oklahoma

Lynn Health Science Institute - Oklahoma City
Oklahoma City, Oklahoma 73112
Dr. William Orr, principal investigator
Contact Aja Larson at 405-602-3921

Oregon

Columbia Research Group, Inc.
New York, New York 10003
Dr. Keith Ironside, principal investigator
Contact Jennifer Croucher at 503-222-1261

Pennsylvania

Mercy Fitzgerald Hospital - Sleep Disorders Center
Lafayette Hill, Pennsylvania 19444
Dr. June Fry, principal investigator
Contact Barrie Levin at 610-828-4060 or blevin@sleepmed.md

Consolidated Clinical Trials
Pittsburgh, Pennsylvania 15221
Dr. David Laman, principal investigator
Contact Suzanne Holbach at 412-273-9100 or smh@consolidatedclinicaltrials.com

South Carolina

SleepMed, Inc. - Columbia
Columbia, South Carolina 29201
Dr. Richard Bogan, principal investigator
Contact Pinckney Simons at 803-251-3093

Texas

Research Across America - Dallas
Dallas, Texas 75234
Dr. Joe Blumenau, principal investigator
Contact Waseem Chughtai at 972-241-1222

Todd J. Swick, M.D., P.A.
Houston, Texas 77063
Dr. Todd Swick, principal investigator
Contact Marilyn Swick at 713-465-7066 or mswick@houstonsleepcenter.com

Germany

Advanced Sleep Research GmbH
Berlin, Germany 10117
Dr. Ingo Fietze, principal investigator
Contact Daniela Frohberg at +493028886770

Bergmannsheil University Hospital - Medical Clinic III
Bochum, Germany 44789
Dr. Joerg Walther,, principal investigator
Contact Erna Brandenburger at +492343023335

Klinische Forschung Hamburg GmbH
Hamburg, Germany 20253
Dr. Susanne Mindt-Pruefert, principal investigator
Contact Ines Weischedel at inesweischedel@gmx.de

Klinische-Forschung Hannover Mitte
Hannover, Germany 30159
Dr. Veronika Richter, principal investigator
Contact Christine Perez-Handel at +495111697650

Universitaetsklinikum Glesen and Marburg gmbH/Schlaflabor - Sleep Lab University Marburg
Marburg, Germany 35043
Dr. Joerg Heitmann, principal investigator
Contact Sandra Apelt at +4964215866832

Bonomed Studiezentrum
Munich, Germany 80331
Dr. Ilonka Eisensehr, principal investigator
Contact Sabine Wunder at +498945226303

For more information about the clinical study, please click here.

• Return to Overview