VEC-162 Study in Adult Patients With Primary Insomnia - Full Text View

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 III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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
1: Experimental VEC-162 20 mg	Drug: VEC-162 20 mg or 50 mg VEC-162 capsules, PO daily for five weeks
2: Experimental VEC-162 50 mg	Drug: VEC-162 20 mg or 50 mg VEC-162 capsules, PO daily for five weeks
3: Placebo Comparator 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

Responsible Party:	Vanda Pharmaceuticals ( Paolo Baroldi, MD, PhD )
Study ID Numbers:	VP-VEC-162-3104
First Received:	October 19, 2007
Last Updated:	July 8, 2008
ClinicalTrials.gov Identifier:	NCT00548340
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Sleep Initiation and Maintenance Disorders

Mental Disorders

Dyssomnias

Sleep Disorders

Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	Vanda Pharmaceuticals
Information provided by:	Vanda Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00548340