Jet Lag Type InsomniaPhase 3NCT03373201
Evaluating the Effects of Tasimelteon vs. Placebo on Jet Lag Type Insomnia
A Phase 3 study testing Tasimelteon in people with Jet Lag Type Insomnia, run by Vanda Pharmaceuticals at 12 sites in United States.
Trial summary
The aim of this study is to investigate tasimelteon vs. placebo on sleep in healthy individuals after a phase advance in jet lag type insomnia. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Jet Lag Type Insomnia
- What is being tested?
- Tasimelteon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 12 sitesUnited States
- Study dates
- 16 Oct 2017to 5 Mar 2018
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability and acceptance to provide written consent, fluent in English;
- Healthy subjects with no medical, psychiatric or current sleep disorders;
- Men or women between 18-75 years;
- Body Mass Index of ≥ 18 and ≤ 30 kg/m2.
Who cannot join
- Major surgery, trauma, illness or immobile for 3 or more days within the past month;
- Pregnancy or recent pregnancy (within 6 weeks);
- A positive test for drugs of abuse at the screening or evaluation visit.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Vanda Investigational Site
Alameda, California, 94501
Vanda Investigational Site
Atlanta, Georgia, 30342
Vanda Investigational Site
Chevy Chase, Maryland, 20815
Vanda Investigational Site
Cincinnati, Ohio, 45212
Vanda Investigational Site
Houston, Texas, 77063
Vanda Investigational Site
Little Rock, Arkansas, 72211
Vanda Investigational Site
New York, New York, 10019
Vanda Investigational Site
Oakland Park, Florida, 33334
Vanda Investigational Site
Oklahoma City, Oklahoma, 73112
Vanda Investigational Site
San Diego, California, 92103
Vanda Investigational Site
Santa Monica, California, 90404
Vanda Investigational Site
St Louis, Missouri, 63141
About this study
The aim of this study is to investigate tasimelteon vs. placebo on sleep in healthy individuals after a phase advance in jet lag type insomnia.
- Conditions
- Jet Lag Type Insomnia
- Being tested
- Tasimelteon, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TasimelteonDrug
Oral capsule
PlaceboDrug
Oral capsule
| Study group | Role | What they receive |
|---|---|---|
| Tasimelteon | Experimental | Not described Receives: Drug: Tasimelteon |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Sleep Time in the First Two Thirds of the Night
Total sleep time during the first 2/3 of the night following an 8-hour phase advance bedtime, as measured by PSG. This is representative of trans meridian travel across 8 time zones.
Measured: 1 Day
Secondary outcomes (5)
Total Sleep Time
Total Sleep Time as measured by PSG.
Measured: 1 Day
Latency to Persistent Sleep
Length of time elapsed between lights out and onset of persistent sleep as measure by PSG.
Measured: 1 Day
Wake After Sleep Onset
The amount of wake time during the sleep period after sleep onset (as measured by polysomnography).
Measured: 1 Day
Next Day Alertness as Measured by the Karolinska Sleepiness Scale (Night 1 Average Score)
A 9-point scale that measures subjective levels of fatigue by asking how sleepy subjects feel at that moment: 1 = extremely awake to 9 =extremely sleepy/fighting to stay awake.
Measured: 1 Day
Next Day Alertness as Measured by the Visual Analogue Scale (Night 1 Average Score)
The VAS was a self-rated scale to assess sleepiness. Participants marked along a 100 mm line to represent their current state of sleepiness, 0 being very sleepy and 100 being very alert. The VAS was administered four times following the dose administration after awakening.
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start16 Oct 2017
- Primary completion5 Mar 2018
- Study completion5 Mar 2018
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 Jet Lag Type 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
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03373201
- Sponsor's protocol ID
- VP-VEC-162-3107
- Status last verified
- Sep 2023
- First submitted
- 31 Oct 2017
- Last updated
- 15 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Polymeropoulos CM, Mohrman MA, Keefe MS, Brzezynski JL, Wang J, Prokosch LS, Polymeropoulos VM, Xiao C, Birznieks G, Polymeropoulos MH. Efficacy of Tasimelteon (HETLIOZ(R)) in the Treatment of Jet Lag Disorder Evaluated in an 8-h Phase Advance Model; a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. Front Neurol. 2020 Jul 9;11:611. doi: 10.3389/fneur.2020.00611. eCollection 2020.
PubMed 32754110
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effects of Tasimelteon vs. Placebo on Jet Lag Type Insomnia
- ClinicalTrials.gov ID
- NCT03373201
- Acronym / sponsor ID
- VP-VEC-162-3107
- Conditions
- Jet Lag Type Insomnia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 5 Mar 2018 (actual)
- Study completion
- 5 Mar 2018 (actual)
- First posted
- 14 Dec 2017 (actual)
- Results
- Posted 15 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate tasimelteon vs. placebo on sleep in healthy individuals after a phase advance in jet lag type insomnia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tasimelteon | Experimental | Drug: Tasimelteon |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ability and acceptance to provide written consent, fluent in English;
- Healthy subjects with no medical, psychiatric or current sleep disorders;
- Men or women between 18-75 years;
- Body Mass Index of ≥ 18 and ≤ 30 kg/m2.
Key exclusion criteria (3 listed)
- Major surgery, trauma, illness or immobile for 3 or more days within the past month;
- Pregnancy or recent pregnancy (within 6 weeks);
- A positive test for drugs of abuse at the screening or evaluation visit.
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 |
|---|---|---|
| TasimelteonOral capsule | Drug | Tasimelteon |
| PlaceboOral capsule | Drug | Placebo |
Primary outcome
Total Sleep Time in the First Two Thirds of the Night
Time frame: 1 Day
Total sleep time during the first 2/3 of the night following an 8-hour phase advance bedtime, as measured by PSG. This is representative of trans meridian travel across 8 time zones.
5 secondary outcomes
Total Sleep Time
Time frame: 1 Day
Latency to Persistent Sleep
Time frame: 1 Day
Wake After Sleep Onset
Time frame: 1 Day
Next Day Alertness as Measured by the Karolinska Sleepiness Scale (Night 1 Average Score)
Time frame: 1 Day
Next Day Alertness as Measured by the Visual Analogue Scale (Night 1 Average Score)
Time frame: 1 Day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32754110Polymeropoulos CM, Mohrman MA, Keefe MS, Brzezynski JL, Wang J, Prokosch LS, Polymeropoulos VM, Xiao C, Birznieks G, Polymeropoulos MH. Efficacy of Tasimelteon (HETLIOZ(R)) in the Treatment of Jet Lag Disorder Evaluated in an 8-h Phase Advance Model; a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. Front Neurol. 2020 Jul 9;11:611. doi: 10.3389/fneur.2020.00611. eCollection 2020.
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.
12 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 Tasimelteon in people with Jet Lag Type Insomnia, run by Vanda Pharmaceuticals at 12 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 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 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 Sep 2023). 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?
Total Sleep Time in the First Two Thirds of the Night (time frame: 1 Day). 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 NCT03373201, 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 Sep 2023.