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VEC-162 Study in Adult Patients With Primary Insomnia

This study has been completed.
Sponsor:
Information provided by:
Vanda Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00548340
First received: October 19, 2007
Last updated: June 9, 2011
Last verified: June 2011
History of Changes
  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
Drug: Placebo
 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 latency to persistent sleep (LPS) [ Time Frame: baseline and short-term in-treatment time points ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Average Wake After Sleep Onset (WASO), sleep duration, subjective measures of sleep, and safety and tolerability [ Time Frame: all in-treatment time points across five week period ] [ Designated as safety issue: Yes ]

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: 1
VEC-162 20 mg
 Drug: VEC-162
20 mg or 50 mg VEC-162 capsules, PO daily for five weeks
Experimental: 2
VEC-162 50 mg
 Drug: VEC-162
20 mg or 50 mg VEC-162 capsules, PO daily for five weeks
Placebo Comparator: 3
Placebo
 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
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: Paolo Baroldi, MD, PhD, Vanda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00548340     History of Changes
Other Study ID Numbers: VP-VEC-162-3104
Study First Received: October 19, 2007
Last Updated: June 9, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 16, 2013