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A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder

Primary Purpose

Jet Lag Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tasimelteon
Placebo
Sponsored by
Vanda Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Jet Lag Disorder

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Ability and acceptance to provide written consent
  • Men or women between 18-75 years
  • Body Mass Index of ≥ 18 and ≤ 30 kg/m2

Exclusion Criteria:

  • 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

Sites / Locations

  • 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

tasimelteon, administered as oral capsule(s)

Placebo, administered as oral capsule(s)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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".
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.
Subjective Total Sleep Time on Night 3
Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline
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.
Subjective Sleep Latency Night 3
Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline
Subjective Wake After Sleep Onset Night 3
Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline
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.

Full Information

First Posted
September 8, 2016
Last Updated
October 5, 2021
Sponsor
Vanda Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03291041
Brief Title
A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder
Official Title
A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vanda Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jet Lag Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tasimelteon
Arm Type
Experimental
Arm Description
tasimelteon, administered as oral capsule(s)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, administered as oral capsule(s)
Intervention Type
Drug
Intervention Name(s)
Tasimelteon
Intervention Description
capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
capsule
Primary Outcome Measure Information:
Title
Total Sleep Time in the First Two-Thirds of the Night on the Night(s) Most Likely to be Disrupted
Description
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.
Time Frame
4 days
Secondary Outcome Measure Information:
Title
Patient Global Impression of Severity (PGI-S) Day 4
Description
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".
Time Frame
1 Day
Title
Total Sleep Time in the First Two-Thirds of the Night (All 3 Nights)
Description
Measured using polysomnography (PSG) and analyzed as change from baseline. The baseline was the corresponding measurement in the screening flight.
Time Frame
3 Days
Title
Subjective Total Sleep Time on Night 3
Description
Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline
Time Frame
1 Day
Title
Subjective Sleep Quality Night 3
Description
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.
Time Frame
1 Day
Title
Subjective Sleep Latency Night 3
Description
Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline
Time Frame
1 Day
Title
Subjective Wake After Sleep Onset Night 3
Description
Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline
Time Frame
1 Day
Title
Karolinska Sleepiness Scale Day 4
Description
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.
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 Men or women between 18-75 years Body Mass Index of ≥ 18 and ≤ 30 kg/m2 Exclusion Criteria: 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
Facility Information:
Facility Name
Vanda Investigational Site
City
Alameda
State/Province
California
ZIP/Postal Code
94501
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
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder

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