Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

VEC-162 Study in Adult Patients With Primary Insomnia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vanda Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00548340
First received: October 19, 2007
Last updated: October 8, 2014
Last verified: October 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00548340

  Show 35 Study Locations
Sponsors and Collaborators
Vanda Pharmaceuticals
  More Information

No publications provided

Responsible Party: Vanda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00548340     History of Changes
Other Study ID Numbers: VP-VEC-162-3104
Study First Received: October 19, 2007
Results First Received: February 28, 2014
Last Updated: October 8, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 20, 2014