Clinical trial NCT03291041
Conditions: Jet Lag Disorder
Sponsor: Vanda Pharmaceuticals
Start date: 2016-07-01; Completion date: 2017-11-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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

Detailed description:

Arms: arm 1: tasimelteon, administered as oral capsule(s) arm 2: Placebo, administered as oral capsule(s)
Interventions: intervention 1: Tasimelteon intervention 2: Placebo
Intervention descriptions: intervention 1: capsule intervention 2: capsule

Protocol documents:
Prot_SAP_000.pdf: 
VP-VEC-162-2102 Amdt. #4 
Vanda Pharmaceuticals 
Confidential 
 
Final  18May2018 
1 
TASIMELTEON 
AMENDMENT #4 VP-VEC-162-2102 
A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, 
PLACEBO-CONTROLLED, PARALLEL PROOF OF 
CONCEPT STUDY TO EVALUATE THE EFFECTS OF 
MULTIPLE ORAL DOSES OF TASIMELTEON AND 
MATCHING PLACEBO IN TRAVELERS WITH JET 
LAG DISORDER 
 
Clinical Study Protocol 
Vanda Pharmaceuticals Inc. 
2200 Pennsylvania Avenue NW 
Suite 300 East 
Washington, DC 20037 
Tasimelteon 
VP-VEC-162-2102 
Phase 2 
128352 
Author(s): 
 
Document Type: 
Sponsor:  
Study Product:  
Protocol Number: 
Study Phase:  
IND Number:  
 
Date:   18 May 2018 
Status:  FINAL 
Number of Pages: 84 


VP-VEC-162-2102 Amdt. #4 
Vanda Pharmaceuticals 
Confidential 
 
Final  18May2018 
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Name of Sponsor/Company: 
Vanda Pharmaceuticals Inc. 
Name of Investigational Product: 
Tasimelteon/VEC-162 
Name of Active Ingredient: 
Tasimelteon/VEC-162 
Title of Study: 
A multicenter, randomized, double-blind, placebo-controlled, parallel proof-of-concept study to 
evaluate the effects of multiple oral doses of tasimelteon and matching placebo in travelers with 
Jet Lag Disorder 
Study center(s): Multicenter (USA and EU) 
Studied period:  
Estimated date first subject enrolled: Aug 2016 
Estimated study duration: approximately 4-6 weeks 
Screening: ≥ 3 weeks, Randomization: 4 days/3 nights 
Phase of development: 
Phase 2 
Number of subjects (planned): Up to 90 eligible subjects will be randomized and assigned to 
20 mg tasimelteon or placebo in a 1:1 ratio.  Treatment assignments will be made according to a 
randomization schedule.   
Diagnosis and main criteria for inclusion/exclusion: 
Males or females 18-75 years of age, inclusive, who demonstrate sleep disturbances associated 
transmeridian travel in study VP-VEC-162-0101. 
Investigational product, dosage and mode of administration:  
Tasimelteon will be administered orally as a dose of 20 mg.  Tasimelteon dosage form will be 
size 1, dark blue, opaque, hard gelatin capsules with two white bars on the capsule body and 
cap, and filled with white to off-white powder. 
Duration of treatment: 
3 nights 
Reference therapy, dosage and mode of administration: 
Placebo capsules will be provided in size and appearance identical to those containing 
tasimelteon and will be administered orally 


VP-VEC-162-2102 Amdt. #4 
Vanda Pharmaceuticals 
Confidential 
 
Final  18May2018 
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Objectives: 
Primary Objectives: 
1.
To assess the effects of tasimelteon 20 mg on nighttime sleep parameters as measured
by Polysomnography (PSG) after transmeridian travel.
Secondary Objectives:
1.
To assess the effects of tasimelteon 20mg on nighttime objective parameters.
2.
To assess the effects of tasimelteon 20mg on nighttime subjective parameters.
3.
To assess the effect of tasimelteon 20mg on a daytime objective parameter.
4.
To assess the effects of tasimelteon 20mg on daytime subjective parameters.
5.
To assess the effects of tasimelteon 20mg as measured by a combined scale of nighttime
and daytime symptoms.
Overall Design:  
This is a multicenter, international, randomized, double-blind, placebo-controlled, parallel 
proof-of-concept trial to investigate the efficacy and safety of multiple 20 mg oral doses of 
tasimelteon and matching placebo in male and female travelers with Jet Lag Disorder (JLD).  
Subjects will be recruited at sites throughout the United States of America (USA) and those that 
meet inclusion/exclusion criteria will be flown from the USA to Europe experiencing a 5-8 hour 
time zone change.   


VP-VEC-162-2102 Amdt. #4 
Vanda Pharmaceuticals 
Confidential 
 
Final  18May2018 
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This study will be divided into 2 phases: the screening phase and the randomization phase.   The 
screening phase consists of the screening visit a visit to re-confirm inclusion/exclusion criteria 
and to conduct the baseline evaluations, and the initial travel period to Europe.   The 
randomization phase consists of a 3-night/4 day double-blind evaluation period in the new time 
zone, and the return travel period to the USA.   The screening visit and the travel period will be 
separated by approximately 3 weeks.  Baseline evaluations will occur approximately three days 
(± 1 day) prior to the transmeridian flight.   Subjects meeting all entry criteria for the study will 
enter the randomization phase.  Eligible subjects will be flown to Europe on a commercial non-
stop, transatlantic, over-night flight.   Subjects will reside in a clinical site in Europe for 4 days 
and 3 nights.  During the evaluation period, subjects will be instructed to take the study 
medication 30 minutes (± 15 min) prior to bedtime and attempt to sleep for 8 hours.   Bedtime 
will be determined by their habitual bedtime in the originating time zone.   For example, if a 
subject has a habitual bedtime of 22:00 pm they will be put to bed at 22:00 pm in the new time 
zone.   A PSG will be performed each night beginning the first night in the new time zone.  On 
Day 4, subjects will be discharged from the study clinic after completing all required study 
procedures and will participate in supervised guided tours.  On Day 5, subjects will take a return 
flight to the USA.  Post-travel, subjects will also be instructed to maintain a sleep schedule 
allowing for an 8-hour sleep opportunity including a bed time consistent with that used while in 
domicile in Europe (± 1 hour).   Throughout the study the subject’s sleep pattern will be 
monitored with an actiwatch and through patient reported sleep diaries. 
Criteria for evaluation: 
Efficacy: 
The primary efficacy variable is TST in the first 2/3 of the night after flying across 5-8 time 
zones.  A comparison will be made between subjects treated with tasimelteon 20 mg and 
placebo.  
Other variables include, PGI-S, TST2/3, TSTfn, LPS, WASO, SE, TSTs, SL, SQs, KSS, and JLQ. 
Safety: 
The safety and tolerability measures will include the recording of adverse events (AEs) 
including suicidal ideation and behavior, clinical laboratory evaluations, vital signs, and 
electrocardiograms (ECGs).   
Statistical Methods: 
 The primary efficacy variable is TST in the first 2/3 of the night after flying across 5-8 time 
zones.  Nighttime sleep will be assessed by analysis of covariance, with treatment group, clinical 
site, baseline and time zone as a main effect.  A comparison will be made between the subjects 
treated with tasimelteon 20 mg and placebo. The primary efficacy analysis will be based on the 
ITT population.  
The statistical analyses will be detailed in the Statistical Analysis Plan.