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VEC-162 Study in Adult Patients With Primary Insomnia

NCT00548340 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 322

Last updated 2014-10-15

Study results available
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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.

Conditions

  • Primary Insomnia

Interventions

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2008-02-29
Completion
2008-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00548340 on ClinicalTrials.gov