Primary InsomniaPhase 3NCT00548340

VEC-162 Study in Adult Patients With Primary Insomnia

A Phase 3 study testing VEC-162 20 mg and VEC-162 50 mg in people with Primary Insomnia, run by Vanda Pharmaceuticals at 35 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 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. Read more about this study

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Primary Insomnia
What is being tested?: VEC-162 20 mg and VEC-162 50 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 322 participants
Where: 35 sitesUnited States
Study dates: Nov 2007to Jun 2008
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 18 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

35 sites in 1 country.

City, postcode or hospital

35 sites in 1 country

United States35 sites

Vanda Investigational Site
Anaheim, California
Vanda Investigational Site
Atlanta, Georgia
Vanda Investigational Site
Austin, Texas
Vanda Investigational Site
Beachwood, Ohio
Vanda Investigational Site
Birmingham, Alabama
Vanda Investigational Site
Burbank, California
Vanda Investigational Site
Chesterfield, Missouri
Vanda Investigational Site
Chevy Chase, Maryland
Vanda Investigational Site
Chicago, Illinois
Vanda Investigational Site
Cincinnati, Ohio
Vanda Investigational Site
Colorado Springs, Colorado
Vanda Investigational Site
Columbia, South Carolina
Vanda Investigational Site
Crestview Hills, Kentucky
Vanda Investigational Site
Dallas, Texas
Vanda Investigational Site
Hallandale, Florida
Vanda Investigational Site
Hot Springs, Arkansas
Vanda Investigational Site
Las Vegas, Nevada
Vanda Investigational Site
Lexington, Kentucky
Vanda Investigational Site
Little Rock, Arkansas
Vanda Investigational Site
Los Angeles, California
Vanda Investigational Site
Louisville, Kentucky
Vanda Investigational Site
Miami, Florida
Vanda Investigational Site
Naples, Florida
Vanda Investigational Site
New York, New York
Vanda Investigational Site
Newton, Massachusetts
Vanda Investigational Site
Oklahoma City, Oklahoma
Vanda Investigational Site
Orlando, Florida
Vanda Investigational Site
Overland Park, Kansas
Vanda Investigational Site
Pembroke Pines, Florida
Vanda Investigational Site
Raleigh, North Carolina
Vanda Investigational Site
San Diego, California
Vanda Investigational Site
Santa Monica, California
Vanda Investigational Site
St. Petersburg, Florida
Vanda Investigational Site
Troy, Michigan
Vanda Investigational Site
West Seneca, New York

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About this 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

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
Being tested: VEC-162 20 mg, Placebo, VEC-162 50 mg
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.

VEC-162 20 mgDrug
20 mg VEC-162 (tasimelteon) capsules, PO daily for five weeks
PlaceboDrug
Placebo capsules, PO daily for five weeks
VEC-162 50 mgDrug
50 mg VEC-162 (tasimelteon) capsules, PO daily for five weeks

Study groups in NCT00548340
Study group	Role	What they receive
VEC-162 20 mg	Experimental	VEC-162 (tasimelteon) 20 mg capsules PO daily for five weeks Receives: Drug: VEC-162 20 mg
VEC-162 50 mg	Experimental	VEC-162 (tasimelteon) 50 mg capsules PO daily for five weeks Receives: Drug: VEC-162 50 mg
Placebo	Placebo comparator	Placebo capsules PO daily five weeks Receives: Drug: Placebo

What is being measured

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

Average Change From Baseline - Latency to Persistent Sleep (LPS)
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.
Measured: Baseline, Night 1, and Night 8 measurement

Secondary outcomes (1)

Average Change From Baseline - Wake After Sleep Onset (WASO) and Total Sleep Time (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.
Measured: Baseline, Night 1, and Night 8 measurements for WASO and TST

Timeline

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

Nov 2007Jun 2008

First posted23 Oct 2007 (estimated)
Study startNov 2007
Primary completionFeb 2008
Study completionJun 2008

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.
Other trials for Primary 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 322 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00548340
Sponsor's protocol ID: VP-VEC-162-3104
Status last verified: Oct 2014
First submitted: 19 Oct 2007
Last updated: 15 Oct 2014
Results posted: Yes, on ClinicalTrials.gov

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?

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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 (20 mg/Day and 50 mg/Day) in the Treatment of Primary Insomnia
ClinicalTrials.gov ID: NCT00548340
Acronym / sponsor ID: VP-VEC-162-3104
Conditions: Primary Insomnia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 322 participants (actual)
Lead sponsor: Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Nov 2007
Primary completion: Feb 2008 (actual)
Study completion: Jun 2008 (actual)
First posted: 23 Oct 2007 (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 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
VEC-162 20 mg	Experimental	Drug: VEC-162 20 mgVEC-162 (tasimelteon) 20 mg capsules PO daily for five weeks
VEC-162 50 mg	Experimental	Drug: VEC-162 50 mgVEC-162 (tasimelteon) 50 mg capsules PO daily for five weeks
Placebo	Placebo comparator	Drug: PlaceboPlacebo capsules PO daily five weeks

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (4 listed)

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.

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
VEC-162 20 mg20 mg VEC-162 (tasimelteon) capsules, PO daily for five weeks	Drug	VEC-162 20 mg
PlaceboPlacebo capsules, PO daily for five weeks	Drug	Placebo
VEC-162 50 mg50 mg VEC-162 (tasimelteon) capsules, PO daily for five weeks	Drug	VEC-162 50 mg

Primary outcome

Average Change From Baseline - Latency to Persistent Sleep (LPS)
Time frame: 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.

1 secondary outcome

Average Change From Baseline - Wake After Sleep Onset (WASO) and Total Sleep Time (TST)
Time frame: Baseline, Night 1, and Night 8 measurements for WASO and TST

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
VEC-162 20 mg	109	101
VEC-162 50 mg	109	98
Placebo	104	95

Primary outcome: Average Change From Baseline - Latency to Persistent Sleep (LPS)

Time frame: Baseline, Night 1, and Night 8 measurement. Mean (Standard Error). Unit: minutes

Measure	VEC-162 20 mg n = 108	VEC-162 50 mg n = 109	Placebo n = 104
Value	45.0 (2.965)	46.4 (2.954)	28.3 (3.020)

Population analysed: One subject randomized to VEC-162 20 mg did not have any post-baseline PSG data and was excluded from the Full Analysis Population.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Night 1 to Day 37 (EOS). Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
VEC-162 20 mg	1 of 109 (0.9%)	15 of 109 (13.8%)	Not reported
VEC-162 50 mg	0 of 109 (0%)	13 of 109 (11.9%)	Not reported
Placebo	1 of 104 (1%)	11 of 109 (10.1%)	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.

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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.

The record lists no contact. Use the official record to reach the sponsor.

35 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 VEC-162 20 mg and VEC-162 50 mg in people with Primary Insomnia, run by Vanda Pharmaceuticals at 35 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 4 inclusion and 4 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 35 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 Change From Baseline - Latency to Persistent Sleep (LPS) (time frame: Baseline, Night 1, and Night 8 measurement). 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 NCT00548340.

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.