VEC-162 Study in Adult Patients With Primary Insomnia

Phase 3

Completed

• Conditions: Primary Insomnia
• Interventions: Drug: VEC-162 20 mg; Drug: VEC-162 50 mg; Drug: Placebo

• Registration Number: NCT00548340
• Lead Sponsor: Vanda Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-10-19
• Study First Submitted QC: 2007-10-19
• Study First Posted: 2007-10-23
• Study Start: 2007-11
• Primary Completion: 2008-02
• Study Completion: 2008-06
• Disposition First Submitted: 2011-06-09
• Disposition First Submitted QC: 2011-06-09
• Disposition First Posted: 2011-06-27
• Results First Submitted: 2014-02-28
• Status Verified: 2014-10
• Results First Submitted QC: 2014-10-08
• Last Update Submitted: 2014-10-08
• Results First Posted: 2014-10-15
• Last Update Posted: 2014-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 322

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VEC-162 20 mg	VEC-162 20 mg	VEC-162 (tasimelteon) 20 mg capsules PO daily for five weeks
VEC-162 50 mg	VEC-162 50 mg	VEC-162 (tasimelteon) 50 mg capsules PO daily for five weeks
Placebo	Placebo	Placebo capsules PO daily five weeks

Primary Outcome Measures

Name	Time	Method
Average Change From Baseline - Latency to Persistent Sleep (LPS)	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

Name	Time	Method
Average Change From Baseline - Wake After Sleep Onset (WASO) and Total Sleep Time (TST)	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.

Trial Locations

Locations (1)

Vanda Investigational Site; 🇺🇸 Dallas, Texas, United States