Circadian Rhythm Sleep DisordersPhase 2NCT00490945

Safety and Efficacy of VEC-162 on Circadian Rhythm in Healthy Adult Volunteers

A Phase 2 study testing VEC-162 in people with Circadian Rhythm Sleep Disorders, run by Vanda Pharmaceuticals at 2 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 assess the safety and efficacy of VEC-162 compared to matching placebo on circadian phase shift and sleep parameters. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Circadian Rhythm Sleep Disorders
What is being tested?: VEC-162
How many people: 45 participants
Where: 2 sitesUnited States
Study dates: Jul 2004to Mar 2005
Phase: Phase 2
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 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

No medical, psychiatric, or sleep disorders
Ability to provide written informed consent

Who cannot join

Lifetime history of night shift work
Evidence of any sleep disorder
Psychiatric or neurological disorders

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Vanda Investigational Site
Boston, Massachusetts
Vanda Investigational Site
Detroit, Michigan

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center Study of the Effects of VEC-162 on Circadian Rhythm in Healthy Subjects

The purpose of this study is to assess the safety and efficacy of VEC-162 compared to matching placebo on circadian phase shift and sleep parameters.

Conditions: Circadian Rhythm Sleep Disorders
Being tested: VEC-162
Medical subject headings: Sleep Disorders, Circadian Rhythm

What participants receive

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

VEC-162Drug

What is being measured

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

Circadian Phase Shift
Exposure response to VEC-162 on induction of circadian phase shift as measured by Dim Light Melatonin Onset (DLMO) was defined as the time change between Night 3 and Night 4 when melatonin production reached 25% of the maximum melatonin concentration. Samples below LOQ of the melatonin assay were assigned 5 pg/ml.
Measured: Night 3 and Night 4
Mean Sleep Efficiency
Exposure response was measured by comparing the change in sleep efficiencies of VEC-162 and placebo treated subjects upon a sleep schedule phase advance. Sleep efficiency (total time asleep divided by the time allowed as an opportunity for sleep in a period multiplied by 100%, where time allowed for sleep was 8 hours or 480 minutes) was measured objectively by overnight polysomnographic recordings. Sleep efficiency was also compared in parts of the night by dividing the full night into thirds.
Measured: Night 4 and Night 2

Secondary outcomes (4)

Wake After Sleep Onset (WASO), and Latency to Persistent Sleep (LPS)
Wake After Sleep Onset is defined as the total time that is scored as awake in a PSG occurring between sleep onset and lights-on prompt.
Latency to Persistent Sleep is defined as the number of epochs (one 30-second interval of the sleep episode) from the beginning of the recording (lights-out) to the start of persistent sleep (first 20 consecutive non-wake state) divided by 2.
Measured: Night 2 and Night 4
VEC-162 AUC
Measured: Night 4
VEC-162 Cmax
Measured: Night 4
VEC-162 Tmax
Measured: Night 4

Timeline

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

Jul 2004Mar 2005

First posted25 Jun 2007 (estimated)
Study startJul 2004
Primary completionMar 2005
Study completionMar 2005

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 Circadian Rhythm Sleep DisordersStudies of the same condition, open and under way.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00490945
Sponsor's protocol ID: VP-VEC-162-2101
Status last verified: Aug 2014
First submitted: 22 Jun 2007
Last updated: 26 Aug 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 Circadian Rhythm Sleep Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center Study of the Effects of VEC-162 on Circadian Rhythm in Healthy Subjects
ClinicalTrials.gov ID: NCT00490945
Acronym / sponsor ID: VP-VEC-162-2101
Conditions: Circadian Rhythm Sleep Disorders
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Jul 2004
Primary completion: Mar 2005 (actual)
Study completion: Mar 2005 (actual)
First posted: 25 Jun 2007 (estimated)
Results: Posted 26 Aug 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 assess the safety and efficacy of VEC-162 compared to matching placebo on circadian phase shift and sleep parameters.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

No medical, psychiatric, or sleep disorders
Ability to provide written informed consent

Key exclusion criteria (3 listed)

Lifetime history of night shift work
Evidence of any sleep disorder
Psychiatric or neurological 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
VEC-162	Drug	–

Primary outcome

Circadian Phase Shift
Time frame: Night 3 and Night 4
Exposure response to VEC-162 on induction of circadian phase shift as measured by Dim Light Melatonin Onset (DLMO) was defined as the time change between Night 3 and Night 4 when melatonin production reached 25% of the maximum melatonin concentration. Samples below LOQ of the melatonin assay were assigned 5 pg/ml.
Mean Sleep Efficiency
Time frame: Night 4 and Night 2
Exposure response was measured by comparing the change in sleep efficiencies of VEC-162 and placebo treated subjects upon a sleep schedule phase advance. Sleep efficiency (total time asleep divided by the time allowed as an opportunity for sleep in a period multiplied by 100%, where time allowed for sleep was 8 hours or 480 minutes) was measured objectively by overnight polysomnographic recordings. Sleep efficiency was also compared in parts of the night by dividing the full night into thirds.

4 secondary outcomes

Wake After Sleep Onset (WASO), and Latency to Persistent Sleep (LPS)
Time frame: Night 2 and Night 4
VEC-162 AUC
Time frame: Night 4
VEC-162 Cmax
Time frame: Night 4
VEC-162 Tmax
Time frame: Night 4

Results and safety

Results posted to the registry on 26 Aug 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	8	8
10 mg VEC-162	9	8
20 mg VEC-162	8	8
50 mg VEC-162	7	7
100 mg VEC-162	7	7

Primary outcome: Circadian Phase Shift

Time frame: Night 3 and Night 4. Mean (Standard Deviation). Unit: Hours

Measure	Placebo n = 6	10 mg VEC-162 n = 8	20 mg VEC-162 n = 7	50 mg VEC-162 n = 4	100 mg VEC-162 n = 5
Value	-0.48 (0.84)	0.18 (2.48)	-1.14 (0.46)	-0.50 (0.32)	-2.74 (1.95)

Primary outcome: Mean Sleep Efficiency

Time frame: Night 4 and Night 2. Mean (Standard Deviation). Unit: % points

Measure	Placebo* n = 7	10 mg VEC-162 n = 8	20 mg VEC-162 n = 8	50 mg VEC-162 n = 7	100 mg VEC-162 n = 7
Full Night (% points)	-20.27 (18.72)	-7.77 (14.98)	-6.68 (12.69)	-5.87 (9.89)	-2.02 (4.94)
1st Third of the Night (% points)	-12.30 (14.51)	-0.47 (12.39)	-7.81 (14.52)	0.95 (7.79)	-5.63 (17.71)
2nd Third of the Night (% points)	-34.92 (38.23)	-12.64 (13.83)	-5.11 (12.78)	-2.10 (4.14)	-2.30 (5.72)
3rd Third of the NIght (% points)	-8.06 (29.69)	-10.51 (35.17)	-7.09 (26.24)	-16.48 (26.25)	1.80 (14.15)

Population analysed: \*N = 6 for 3rd Third of Night Efficiency and N=8 for 1st Third of Night Efficiency \*\*N = 7 for 3rd Third of Night Efficiency

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1st dose to 30 days following last administration of study treatment. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 8 (0%)	8 of 8 (100%)	Not reported
10 mg VEC-162	0 of 9 (0%)	8 of 9 (88.9%)	Not reported
20 mg VEC-162	0 of 8 (0%)	7 of 8 (87.5%)	Not reported
50 mg VEC-162	0 of 7 (0%)	7 of 7 (100%)	Not reported
100 mg VEC-162	0 of 7 (0%)	7 of 7 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 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 Circadian Rhythm Sleep Disorders

Enrolling by invitation
Sleep and Activity For Eating Disorders
Eating Disorders, Anorexia Nervosa
RecruitingObservational study
Body Clocks - Coordination of Peripheral and Central Oscillators
Circadian Dysregulation
Active, not recruiting
Countermeasures to Circadian Misalignment
Circadian Rhythm Sleep Disorder of Shift Work Type, Metabolic Disease
Enrolling by invitationObservational study
Digital Phenotypes for Predicting Depression_Validation
Major Depressive Disorder, Bipolar I Disorder
Not yet recruitingObservational study
Circadian Clock Proteins in Gingival Crevicular Fluid of Individuals With and Without Circadian Rhythm Disruption
Gingivitis, Circadian Rhythm Disruption

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.

Marlene Dressman, PhD study director

Vanda Pharmaceuticals Inc

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VEC-162 in people with Circadian Rhythm Sleep Disorders, run by Vanda Pharmaceuticals at 2 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 26 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 26 Aug 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?

Circadian Phase Shift (time frame: Night 3 and Night 4). The study lists 2 primary outcomes in all. 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 NCT00490945, 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 26 Aug 2014.