Jet Lag DisorderPhase 2NCT03291041
A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder
A Phase 2 study testing Tasimelteon in people with Jet Lag Disorder, run by Vanda Pharmaceuticals at 3 sites in United States.
Trial summary
A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder 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 Disorder
- 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
- 25 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2016to Nov 2017
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability and acceptance to provide written consent
- Men or women between 18-75 years
- Body Mass Index of ≥ 18 and ≤ 30 kg/m2
Who cannot join
- History (within the 12 months prior to screening) of psychiatric disorders
- 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 visit
- Any other sound medical reason as determined by the clinical investigator
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Vanda Investigational Site
Alameda, California, 94501
Vanda Investigational Site
Chevy Chase, Maryland, 20815
Vanda Investigational Site
Santa Monica, California, 90404
About this study
A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder
- Conditions
- Jet Lag Disorder
- Being tested
- Tasimelteon, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TasimelteonDrug
capsule
PlaceboDrug
capsule
| Study group | Role | What they receive |
|---|---|---|
| tasimelteon | Experimental | tasimelteon, administered as oral capsule(s) Receives: Drug: Tasimelteon |
| Placebo | Placebo comparator | Placebo, administered as oral capsule(s) 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 on the Night(s) Most Likely to be Disrupted
Measured using polysomnography (PSG) and analyzed as change from baseline. Examination of the observational phase baseline data demonstrated that Night 3 was the night most disrupted.
Measured: 4 days
Secondary outcomes (7)
Patient Global Impression of Severity (PGI-S) Day 4
Self-reported global index measure analyzed as change from baseline. The baseline was the corresponding measurement in the screening flight. The PGI-S is a single question asking the subject to rate their jet-lag condition at the present time on a scale of 1 "Normal" to 4 "Severe".
Measured: 1 Day
Total Sleep Time in the First Two-Thirds of the Night (All 3 Nights)
Measured using polysomnography (PSG) and analyzed as change from baseline. The baseline was the corresponding measurement in the screening flight.
Measured: 3 Days
Subjective Total Sleep Time on Night 3
Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline
Measured: 1 Day
Subjective Sleep Quality Night 3
Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline. Sleep quality was ranked from 1 "Poor" to 5 "Excellent" and was the subscale of the post-sleep questionnaire used to determine subjective sleep quality.
Measured: 1 Day
Subjective Sleep Latency Night 3
Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline
Measured: 1 Day
Subjective Wake After Sleep Onset Night 3
Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline
Measured: 1 Day
Karolinska Sleepiness Scale Day 4
Self-reported fatigue measure analyzed as change from baseline. The baseline was the corresponding measurement in the screening flight. The KSS is a single question asking the subject to rate how sleepy they feel at that moment on a 9-point scale where 1 = extremely awake and 9 = extremely sleepy/fighting to stay wake.
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 posted25 Sep 2017
- Study startJul 2016
- Primary completionNov 2017
- Study completionNov 2017
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 Jet Lag DisorderStudies 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
- Who is masked
- Participant, Investigator
- Enrolment
- 25 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
- NCT03291041
- Sponsor's protocol ID
- VP-VEC-162-2102
- Status last verified
- Oct 2021
- First submitted
- 8 Sep 2016
- Last updated
- 3 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder
- ClinicalTrials.gov ID
- NCT03291041
- Acronym / sponsor ID
- VP-VEC-162-2102
- Conditions
- Jet Lag Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 25 Sep 2017 (actual)
- Results
- Posted 3 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tasimelteon | Experimental | Drug: Tasimelteontasimelteon, administered as oral capsule(s) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, administered as oral capsule(s) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ability and acceptance to provide written consent
- Men or women between 18-75 years
- Body Mass Index of ≥ 18 and ≤ 30 kg/m2
Key exclusion criteria (5 listed)
- History (within the 12 months prior to screening) of psychiatric disorders
- 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 visit
- Any other sound medical reason as determined by the clinical investigator
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 |
|---|---|---|
| Tasimelteoncapsule | Drug | tasimelteon |
| Placebocapsule | Drug | Placebo |
Primary outcome
Total Sleep Time in the First Two-Thirds of the Night on the Night(s) Most Likely to be Disrupted
Time frame: 4 days
Measured using polysomnography (PSG) and analyzed as change from baseline. Examination of the observational phase baseline data demonstrated that Night 3 was the night most disrupted.
7 secondary outcomes
Patient Global Impression of Severity (PGI-S) Day 4
Time frame: 1 Day
Total Sleep Time in the First Two-Thirds of the Night (All 3 Nights)
Time frame: 3 Days
Subjective Total Sleep Time on Night 3
Time frame: 1 Day
Subjective Sleep Quality Night 3
Time frame: 1 Day
Subjective Sleep Latency Night 3
Time frame: 1 Day
Subjective Wake After Sleep Onset Night 3
Time frame: 1 Day
Karolinska Sleepiness Scale Day 4
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 3 Nov 2021.
- 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.
3 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 Tasimelteon in people with Jet Lag Disorder, run by Vanda Pharmaceuticals at 3 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 3 inclusion and 5 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 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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 3 Nov 2021). 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 on the Night(s) Most Likely to be Disrupted (time frame: 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2021.