NCT00291187

Brief Summary

The purpose of this study is to determine the safety and efficacy of VEC-162 compared to placebo to improve sleep parameters in a model of insomnia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
411

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2006

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 13, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
8.2 years until next milestone

Results Posted

Study results publicly available

October 15, 2014

Completed
Last Updated

October 15, 2014

Status Verified

October 1, 2014

Enrollment Period

6 months

First QC Date

February 3, 2006

Results QC Date

February 28, 2014

Last Update Submit

October 8, 2014

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

  • Average Improvement of Latency to Persistent Sleep (LPS)

    The average improvement in Latency to persistent sleep (the number of minutes between Lights Off and the onset of at least 10 minutes of persistent sleep, as measured by polysomnography) is defined as the difference observed in the VEC-162 treated subjects compared with placebo treated subjects.

    Night 1

Secondary Outcomes (1)

  • Average Improvement of Wake After Sleep Onset (WASO)

    Night 1

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Take orally 30 minutes prior to bedtime.

Drug: Placebo

20 mg VEC-162

EXPERIMENTAL

20 mg taken orally 30 minutes prior to bedtime.

Drug: 20 mg VEC-162

50 mg VEC-162

EXPERIMENTAL

50 mg taken orally 30 minutes prior to bedtime.

Drug: 50 mg VEC-162

100 mg VEC-162

EXPERIMENTAL

100 mg taken orally 30 minutes prior to bedtime.

Drug: 100 mg VEC-162

Interventions

20 mg VEC-162DRUG

20 mg VEC-162

20 mg VEC-162
50 mg VEC-162DRUG

50 mg VEC-162

50 mg VEC-162
100 mg VEC-162DRUG

100 mg VEC-162

100 mg VEC-162
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects with no medical, psychiatric or current sleep disorders.
  • Subject must sign a written consent form.

You may not qualify if:

  • Recent history of night shift work or jet lag.
  • Prior experience sleeping in a sleep lab environment.
  • History of sleep disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Vanda Investigational Site

Birmingham, Alabama, United States

Location

Vanda Investigational Site

Phoenix, Arizona, United States

Location

Vanda Investigational Site

San Diego, California, United States

Location

Vanda Investigational Site

San Francisco, California, United States

Location

Vanda Investigational Site

Santa Monica, California, United States

Location

Vanda Investigational Site

Miami, Florida, United States

Location

Vanda Investigational Site

Naples, Florida, United States

Location

Vanda Investigational Site

Pembroke Pines, Florida, United States

Location

Vanda Investigational Site

St. Petersburg, Florida, United States

Location

Vanda Investigational Site

Atlanta, Georgia, United States

Location

Vanda Investigational Site

Overland Park, Kansas, United States

Location

Vanda Investigational Site

Chevy Chase, Maryland, United States

Location

Vanda Investigational Site

New York, New York, United States

Location

Vanda Investigational Site

Rochester, New York, United States

Location

Vanda Investigational Site

Raleigh, North Carolina, United States

Location

Vanda Investigational Site

Cincinnati, Ohio, United States

Location

Vanda Investigational Site

Columbia, South Carolina, United States

Location

Vanda Investigational Site

Austin, Texas, United States

Location

Vanda Investigational Site

Plano, Texas, United States

Location

Related Publications (1)

  • Rajaratnam SM, Polymeropoulos MH, Fisher DM, Roth T, Scott C, Birznieks G, Klerman EB. Melatonin agonist tasimelteon (VEC-162) for transient insomnia after sleep-time shift: two randomised controlled multicentre trials. Lancet. 2009 Feb 7;373(9662):482-91. doi: 10.1016/S0140-6736(08)61812-7. Epub 2008 Dec 4.

    PMID: 19054552DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Results Point of Contact

Title
Marlene Dressman, PhD.
Organization
Vanda Pharmaceuticals Inc.
marlene.dressman@vandapharma.com
202-734-3462

Study Officials

  • Vanda Pharmaceuticals

    Vanda Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2006

First Posted

February 13, 2006

Study Start

February 1, 2006

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

October 15, 2014

Results First Posted

October 15, 2014

Record last verified: 2014-10

Locations

US(19)