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Trial record 2 of 21 for:    VEC-162

VEC-162 Study in Adult Patients With Primary Insomnia

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ClinicalTrials.gov Identifier: NCT00548340
Recruitment Status : Completed
First Posted : October 23, 2007
Results First Posted : October 15, 2014
Last Update Posted : October 15, 2014
Sponsor:
Information provided by (Responsible Party):
Vanda Pharmaceuticals

October 19, 2007
October 23, 2007
February 28, 2014
October 15, 2014
October 15, 2014
November 2007
February 2008   (Final data collection date for primary outcome measure)
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.
Average latency to persistent sleep (LPS)
Complete list of historical versions of study NCT00548340 on ClinicalTrials.gov Archive Site
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.
Average Wake After Sleep Onset (WASO), sleep duration, subjective measures of sleep, and safety and tolerability
Not Provided
Not Provided
 
VEC-162 Study in Adult Patients With Primary Insomnia
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Primary Insomnia
  • Drug: VEC-162 20 mg
    20 mg VEC-162 (tasimelteon) capsules, PO daily for five weeks
  • Drug: Placebo
    Placebo capsules, PO daily for five weeks
  • Drug: VEC-162 50 mg
    50 mg VEC-162 (tasimelteon) capsules, PO daily for five weeks
  • Experimental: VEC-162 20 mg
    VEC-162 (tasimelteon) 20 mg capsules PO daily for five weeks
    Intervention: Drug: VEC-162 20 mg
  • Experimental: VEC-162 50 mg
    VEC-162 (tasimelteon) 50 mg capsules PO daily for five weeks
    Intervention: Drug: VEC-162 50 mg
  • Placebo Comparator: Placebo
    Placebo capsules PO daily five weeks
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
322
324
June 2008
February 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 64 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00548340
VP-VEC-162-3104
Not Provided
Not Provided
Not Provided
Vanda Pharmaceuticals
Vanda Pharmaceuticals
Not Provided
Not Provided
Vanda Pharmaceuticals
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP