InsomniaPhase 3NCT00291187

VEC-162 Study in Healthy Adult Volunteers in a Model of Insomnia

A Phase 3 study testing 20 mg VEC-162, 50 mg VEC-162 and 100 mg VEC-162 in people with Insomnia, run by Vanda Pharmaceuticals at 19 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 21 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Insomnia
What is being tested?: 20 mg VEC-162, 50 mg VEC-162 and 100 mg VEC-162
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 411 participants
Where: 19 sitesUnited States
Study dates: Feb 2006to Aug 2006
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

19 sites in 1 country.

City, postcode or hospital

19 sites in 1 country

United States19 sites

Vanda Investigational Site
Atlanta, Georgia
Vanda Investigational Site
Austin, Texas
Vanda Investigational Site
Birmingham, Alabama
Vanda Investigational Site
Chevy Chase, Maryland
Vanda Investigational Site
Cincinnati, Ohio
Vanda Investigational Site
Columbia, South Carolina
Vanda Investigational Site
Miami, Florida
Vanda Investigational Site
Naples, Florida
Vanda Investigational Site
New York, New York
Vanda Investigational Site
Overland Park, Kansas
Vanda Investigational Site
Pembroke Pines, Florida
Vanda Investigational Site
Phoenix, Arizona
Vanda Investigational Site
Plano, Texas
Vanda Investigational Site
Raleigh, North Carolina
Vanda Investigational Site
Rochester, New York
Vanda Investigational Site
San Diego, California
Vanda Investigational Site
San Francisco, California
Vanda Investigational Site
Santa Monica, California
Vanda Investigational Site
St. Petersburg, Florida

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Study to Investigate the Efficacy and Safety of VEC-162 and Matching Placebo in Healthy Male and Female Subjects With Induced Transient Insomnia

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.

Conditions: Insomnia
Being tested: 20 mg VEC-162, 50 mg VEC-162, 100 mg VEC-162, Placebo
Medical subject headings: Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

20 mg VEC-162Drug
20 mg VEC-162
50 mg VEC-162Drug
50 mg VEC-162
100 mg VEC-162Drug
100 mg VEC-162
PlaceboDrug
Placebo

Study groups in NCT00291187
Study group	Role	What they receive
Placebo	Placebo comparator	Take orally 30 minutes prior to bedtime. Receives: Drug: Placebo
20 mg VEC-162	Experimental	20 mg taken orally 30 minutes prior to bedtime. Receives: Drug: 20 mg VEC-162
50 mg VEC-162	Experimental	50 mg taken orally 30 minutes prior to bedtime. Receives: Drug: 50 mg VEC-162
100 mg VEC-162	Experimental	100 mg taken orally 30 minutes prior to bedtime. Receives: Drug: 100 mg VEC-162

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Night 1

Secondary outcomes (1)

Average Improvement of Wake After Sleep Onset (WASO)
The average improvement of wake after sleep onset (time spent awake between onset of sleep and lights on, determined by PSG) is defined as the difference observed in the VEC-162 treated subjects compared with placebo treated subjects.
Measured: Night 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2006Aug 2006

First posted13 Feb 2006 (estimated)
Study startFeb 2006
Primary completionAug 2006
Study completionAug 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for InsomniaStudies of the same condition, open and under way.
More trials run by Vanda PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 411 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00291187
Sponsor's protocol ID: VP-VEC-162-3101
Status last verified: Oct 2014
First submitted: 3 Feb 2006
Last updated: 15 Oct 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 19054552

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Insomnia trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Study to Investigate the Efficacy and Safety of VEC-162 and Matching Placebo in Healthy Male and Female Subjects With Induced Transient Insomnia
ClinicalTrials.gov ID: NCT00291187
Acronym / sponsor ID: VP-VEC-162-3101
Conditions: Insomnia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 411 participants (actual)
Lead sponsor: Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Feb 2006
Primary completion: Aug 2006 (actual)
Study completion: Aug 2006 (actual)
First posted: 13 Feb 2006 (estimated)
Results: Posted 15 Oct 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboTake orally 30 minutes prior to bedtime.
20 mg VEC-162	Experimental	Drug: 20 mg VEC-16220 mg taken orally 30 minutes prior to bedtime.
50 mg VEC-162	Experimental	Drug: 50 mg VEC-16250 mg taken orally 30 minutes prior to bedtime.
100 mg VEC-162	Experimental	Drug: 100 mg VEC-162100 mg taken orally 30 minutes prior to bedtime.

Who may qualify

Ages: 21 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
20 mg VEC-16220 mg VEC-162	Drug	20 mg VEC-162
50 mg VEC-16250 mg VEC-162	Drug	50 mg VEC-162
100 mg VEC-162100 mg VEC-162	Drug	100 mg VEC-162
PlaceboPlacebo	Drug	Placebo

Primary outcome

Average Improvement of Latency to Persistent Sleep (LPS)
Time frame: Night 1
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.

1 secondary outcome

Average Improvement of Wake After Sleep Onset (WASO)
Time frame: Night 1

Results and safety

Results posted to the registry on 15 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	103	103
VEC-162 20 mg	100	100
VEC-162 50 mg	103	102
VEC-162 100 mg	106	106

Primary outcome: Average Improvement of Latency to Persistent Sleep (LPS)

Time frame: Night 1. Mean (Standard Error). Unit: minutes

Measure	Placebo n = 103	VEC-162 20 mg n = 100	VEC-162 50 mg n = 102	VEC-162 100 mg n = 106
Value	45.8 (4.28)	24.3 (4.35)	19.6 (4.31)	23.1 (4.21)

Placebo vs VEC-162 20 mg: Mean Difference (Final Values): -21.5 (95% CI -33.1 to -9.9), p <0.001, ANCOVA
Placebo vs VEC-162 50 mg: Mean Difference (Final Values): -26.3 (95% CI -37.8 to -14.7), p <0.001, ANCOVA
Placebo vs VEC-162 100 mg: Mean Difference (Final Values): -22.8 (95% CI -34.2 to -11.3), p <0.001, ANCOVA

Population analysed: Modified ITT defined as any subject randomized into the study who received a dose of study drug and had PSG data. For the purposes of this trial, a subject was considered to have PSG data if 50% or more of the full night PSG was scored.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Day 1 through Day 2.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 103 (0%)	5 of 103 (4.9%)	Not reported
VEC-162 20 mg	0 of 100 (0%)	7 of 100 (7%)	Not reported
VEC-162 50 mg	0 of 102 (0%)	5 of 102 (4.9%)	Not reported
VEC-162 100 mg	0 of 106 (0%)	6 of 106 (5.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 19054552Rajaratnam 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.

Related trials for Insomnia

Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Recruiting
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Recruiting
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A Trial to See if Daridorexant Can Help Adults and Elderly People With Insomnia Sleep Better During the Night and Function Better During the Day
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Vanda Pharmaceuticals study director

Vanda Pharmaceuticals

19 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 20 mg VEC-162, 50 mg VEC-162 and 100 mg VEC-162 in people with Insomnia, run by Vanda Pharmaceuticals at 19 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average Improvement of Latency to Persistent Sleep (LPS) (time frame: Night 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00291187, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2014.