Back to resultsEvaluating the Effects of Tasimelteon vs. Placebo on Jet Lag Type Insomnia
Primary Purpose
Jet Lag Type Insomnia
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tasimelteon
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Jet Lag Type Insomnia
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Vanda Investigational Site
- Vanda Investigational Site
- Vanda Investigational Site
- Vanda Investigational Site
- Vanda Investigational Site
- Vanda Investigational Site
- Vanda Investigational Site
- Vanda Investigational Site
- Vanda Investigational Site
- Vanda Investigational Site
- Vanda Investigational Site
- Vanda Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Tasimelteon
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Total Sleep Time
Total Sleep Time as measured by PSG.
Latency to Persistent Sleep
Length of time elapsed between lights out and onset of persistent sleep as measure by PSG.
Wake After Sleep Onset
The amount of wake time during the sleep period after sleep onset (as measured by polysomnography).
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.
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.
Full Information
NCT ID
NCT03373201
First Posted
October 31, 2017
Last Updated
September 12, 2023
Sponsor
Vanda Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT03373201
Brief Title
Evaluating the Effects of Tasimelteon vs. Placebo on Jet Lag Type Insomnia
Official Title
Evaluating the Effects of Tasimelteon vs. Placebo on Jet Lag Type Insomnia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 16, 2017 (Actual)
Primary Completion Date
March 5, 2018 (Actual)
Study Completion Date
March 5, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vanda Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jet Lag Type Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
320 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tasimelteon
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Tasimelteon
Intervention Description
Oral capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral capsule
Primary Outcome Measure Information:
Title
Total Sleep Time in the First Two Thirds of the Night
Description
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.
Time Frame
1 Day
Secondary Outcome Measure Information:
Title
Total Sleep Time
Description
Total Sleep Time as measured by PSG.
Time Frame
1 Day
Title
Latency to Persistent Sleep
Description
Length of time elapsed between lights out and onset of persistent sleep as measure by PSG.
Time Frame
1 Day
Title
Wake After Sleep Onset
Description
The amount of wake time during the sleep period after sleep onset (as measured by polysomnography).
Time Frame
1 Day
Title
Next Day Alertness as Measured by the Karolinska Sleepiness Scale (Night 1 Average Score)
Description
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.
Time Frame
1 Day
Title
Next Day Alertness as Measured by the Visual Analogue Scale (Night 1 Average Score)
Description
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.
Time Frame
1 Day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Vanda Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Vanda Investigational Site
City
Alameda
State/Province
California
ZIP/Postal Code
94501
Country
United States
Facility Name
Vanda Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Vanda Investigational Site
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Vanda Investigational Site
City
Oakland Park
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
Vanda Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Vanda Investigational Site
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Vanda Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Vanda Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Vanda Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Vanda Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Vanda Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77063
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
32754110
Citation
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.
Results Reference
derived
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Evaluating the Effects of Tasimelteon vs. Placebo on Jet Lag Type Insomnia
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