We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

VEC-162 Study in Adult Patients With Primary Insomnia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00548340
First Posted: October 23, 2007
Last Update Posted: October 15, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Vanda Pharmaceuticals
  Purpose
The purpose of this study is to evaluate the efficacy and safety of a 5 week double-blind treatment period of VEC-162 as compared to placebo in male and female patients with primary insomnia.

Condition Intervention Phase
Primary Insomnia Drug: VEC-162 20 mg Drug: Placebo Drug: VEC-162 50 mg Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Investigate the Efficacy and Safety of VEC-162 (20 mg/Day and 50 mg/Day) in the Treatment of Primary Insomnia

Further study details as provided by Vanda Pharmaceuticals:

Primary Outcome Measures:
  • Average Change From Baseline - Latency to Persistent Sleep (LPS) [ Time Frame: Baseline, Night 1, and Night 8 measurement ]
    Average latency to persistent sleep is defined as the length of time elapsed between lights off and onset of persistent sleep (defined as the point at which 10 minutes of uninterrupted sleep has begun as determined by PSG) between Baseline and the average of nights 1 and 8.


Secondary Outcome Measures:
  • Average Change From Baseline - Wake After Sleep Onset (WASO) and Total Sleep Time (TST) [ Time Frame: Baseline, Night 1, and Night 8 measurements for WASO and TST ]
    Average wake after sleep onset was defined as the time spent awake between onset of sleep (latency to non-awake) and lights-on, as determined by PSG between Baseline, and the average of nights 1 and 8. Total sleep time (TST) was defined as the time spent sleeping between lights-out and lights-on, i.e., full night between Baseline, and the average of nights 1 and 8.


Enrollment: 322
Study Start Date: November 2007
Study Completion Date: June 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VEC-162 20 mg
VEC-162 (tasimelteon) 20 mg capsules PO daily for five weeks
Drug: VEC-162 20 mg
20 mg VEC-162 (tasimelteon) capsules, PO daily for five weeks
Experimental: VEC-162 50 mg
VEC-162 (tasimelteon) 50 mg capsules PO daily for five weeks
Drug: VEC-162 50 mg
50 mg VEC-162 (tasimelteon) capsules, PO daily for five weeks
Placebo Comparator: Placebo
Placebo capsules PO daily five weeks
Drug: Placebo
Placebo capsules, PO daily for five weeks

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females with a diagnosis of primary insomnia as defined in DSM-IV.
  • Habitual bedtime between 9:00 pm and 1:00 am.
  • No history or evidence of restless leg syndrome or periodic limb movement disorder or sleep apnea.
  • Patients must sign a written consent form.

Exclusion Criteria:

  • History of drug or alcohol abuse as defined in DSM-IV.
  • History of psychiatric disorders, including Major Depressive Disorder, Generalized Anxiety Disorder and delirium.
  • History of chronic obstructive pulmonary disease (COPD), seizures, sleep apnea, narcolepsy, circadian-rhythm sleep disorder, parasomnia or any sleep disorder other than chronic insomnia.
  • Recent history of shift work or jet lag.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00548340


  Show 35 Study Locations
Sponsors and Collaborators
Vanda Pharmaceuticals
  More Information

Responsible Party: Vanda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00548340     History of Changes
Other Study ID Numbers: VP-VEC-162-3104
First Submitted: October 19, 2007
First Posted: October 23, 2007
Results First Submitted: February 28, 2014
Results First Posted: October 15, 2014
Last Update Posted: October 15, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders