Withdrawal Study to Demonstrate the Maintenance Effect in the Treatment of Non-24-Hour Sleep-Wake Disorder

NCT01430754 | Completed Phase 3 Results

• 1 other identifier: VP-VEC-162-3203
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 22

Brief Summary

The purpose of this study is to evaluate the maintenance effect and safety of 20 mg tasimelteon versus placebo in subjects suffering from Non-24-Hour Sleep-Wake Disorder.

Conditions

Non-24-Hour Sleep-Wake Disorder

Keywords

Blindness; Eye Diseases; Nap Disorders; Circadian Rhythm Disorders; Sleep Disorders; Circadian Rhythm Sleep Disorders; Dyssomnias; Nervous System Diseases

Outcome Measures

Primary Outcomes (1)

• Maintenance of Entrainment (aMT6s) in Subjects With N24HSWD.

  Entrainment is a measure of synchronization of the master body clock to the 24-hour day. The circadian period (τ) was calculated using urinary aMT6s collected over four separate 48 hour periods, approximately 1 week apart, during the run-in and randomized phases of the trial. Maintenance of entrainment is defined as the proportion of subjects who become non-entrained to a 24 hour day after randomization to tasimelteon or placebo. Non-entrainment was defined as having a post-baseline τ value ≥ 24.1 or the lower bound of the 95% CI \>24.0.

  Approximately 12 weeks

Secondary Outcomes (5)

• Maintenance of Entrainment (Cortisol) in Subjects With N24HSWD

  Approximately 12 weeks

• Change From Run-In in Subjective Nighttime Total Sleep Time in Lower Quartile of Days (LQ-nTST) During the Randomized Phase

  Approximately 12 weeks

• Change From Run-In in Total Daytime Sleep Duration in Lower Quartile of Days (UQ-dTSD) During the Randomized Phase

  Approximately 12 weeks

• Change From Run-In in Midpoint of Sleep (MoST) During the Randomized Phase

  Approximately 12 weeks

• Change From Run-In in Circadian Time to Relapse During the Randomized Phase

  Approximately 8 weeks

Study Arms (2)

tasimelteon

EXPERIMENTAL

20 mg tasimelteon capsules

Drug: tasimelteon

Placebo

PLACEBO COMPARATOR

Placebo capsules

Drug: Placebo

Interventions

tasimelteon DRUG

20 mg tasimelteon capsules, daily

Also known as: VEC-162

tasimelteon

Placebo DRUG

Placebo capsules, daily

Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability and acceptance to provide informed consent;
• Males, non-fecund females (i.e., surgically sterilized, if procedure was done 6 months before screening or subject is postmenopausal, without menses for 6 months before screening), or females of child-bearing potential using an acceptable method of birth control for a period of 35 days before the first dosing and must have a negative pregnancy test at the screening and baseline visits; Note: Women using hormonal methods of birth control must use an additional method of birth control during the study and for one month after the last dose.
• Willing and able to comply with study requirements and restrictions including a commitment to a fixed 9-hour sleep opportunity during the study;
• Diagnosis of N24HSWD in a previous clinical trial as measured by a tau value of \> 24.1 and the lower bound of the 95% CI is \> 24.

You may not qualify if:

• 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 is not being successfully treated or has not been resolved and 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;
• History of drug or alcohol abuse as defined in DSM-IV, Diagnostic Criteria for Drug and Alcohol Abuse, within the 12 months prior to screening and/or regular consumption of alcoholic drinks (\> 2 drinks/day or \> 14 drinks/week);
• a. Note: A standard drink is equal to 13.7 grams (0.6 ounces) of pure alcohol or
• ounces of beer
• ounces of malt liquor
• ounces of wine
• ounces or a "shot" of 80-proof distilled spirits or liquor (e.g., gin, rum, vodka, or whiskey);
• Subject is at risk of suicide, in the opinion of the Investigator. Evidence of suicide risk could include any suicide attempt within the past year or any other suicidal behavior within the past year;
• Current clinically significant cardiovascular, respiratory, neurologic, hepatic, hematopoietic, renal, gastrointestinal or metabolic dysfunction unless currently controlled and stable;
• Subjects who have estimated creatinine clearance (CLcr; based on the Cockcroft-Gault equation) ≤ to 55 mL/min;
• Clinically significant deviation from normal in clinical laboratory results, vital signs measurements, or physical examination findings at screening as determined by the clinical investigator;
• Indication of impaired liver function (values for AST, ALT or bilirubin \> 2 times Upper Limit of Normal);
• Pregnant or lactating females;
• A positive test for drugs of abuse at the screening visit; Note: A positive drug screen at Visit 1 needs to be discussed with the medical monitor and will be evaluated on a case-by-case basis.

Sponsors & Collaborators

• Vanda Pharmaceuticals: lead

Study Sites (22)

Pulmonary Associates, PA

Phoenix, Arizona, 85006, United States

Location

SDS Clinical Trials Inc.

Orange, California, 92868, United States

Location

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

Palo Alto, California, 94304, United States

Location

St. Johns Sleep Disorder Center - St. Johns Medical Plaza

Santa Monica, California, 90404, United States

Location

Radiant Research - Denver

Denver, Colorado, 80239, United States

Location

PAB Clinical Research Inc.

Brandon, Florida, 33511, United States

Location

Kendall South Medical Center, Inc.

Miami, Florida, 33175, United States

Location

Ocean Sleep Disorders Center - Ormond Beach

Ormond Beach, Florida, 32174, United States

Location

Sleep Disorders Center Of Georgia

Atlanta, Georgia, 30342, United States

Location

Suburban Lung Associates SC

Elk Grove Village, Illinois, 60007, United States

Location

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

Chevy Chase, Maryland, 20815, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Michigan Head-Pain Neurological Institute

Ann Arbor, Michigan, 48104, United States

Location

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

Chesterfield, Missouri, 63017, United States

Location

New York Eye and Ear Infirmary

New York, New York, 10003, United States

Location

Ohio Sleep Medicine Institute (Columbus Metropolitan Area)

Dublin, Ohio, 43017, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Columbia Research Group Inc.

Portland, Oregon, 97239, United States

Location

Mercy Fitzgerald Hospital - Sleep Disorders Center (Philadelphia Metropolitan Area)

Lafayette Hill, Pennsylvania, 19444, United States

Location

Consolidated Clinical trials

Pittsburgh, Pennsylvania, 15221, United States

Location

SleepMed, Inc. - Columbia

Columbia, South Carolina, 29201, United States

Location

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

Houston, Texas, 77063, United States

Location

Related Publications (1)

• Lockley SW, Dressman MA, Licamele L, Xiao C, Fisher DM, Flynn-Evans EE, Hull JT, Torres R, Lavedan C, Polymeropoulos MH. Tasimelteon for non-24-hour sleep-wake disorder in totally blind people (SET and RESET): two multicentre, randomised, double-masked, placebo-controlled phase 3 trials. Lancet. 2015 Oct 31;386(10005):1754-64. doi: 10.1016/S0140-6736(15)60031-9. Epub 2015 Aug 4.

  PMID: 26466871 DERIVED

MeSH Terms

Conditions

Sleep Disorders, Circadian Rhythm; Blindness; Eye Diseases; Chronobiology Disorders; Sleep Wake Disorders; Dyssomnias; Nervous System Diseases

Interventions

tasimelteon

Condition Hierarchy (Ancestors)

Occupational Diseases; Mental Disorders; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Marlene Dressman, Ph.D.
• Organization: Vanda Pharmaceuticals Inc.

marlene.dressman@vandapharma.com

202-734-3462

Study Officials

• Vanda Pharmaceuticals

  Vanda Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2011
• First Posted: September 8, 2011
• Study Start: September 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: October 10, 2014
• Results First Posted: October 10, 2014

Record last verified: 2014-10

Locations

US (22)