Clinical trial NCT03373201: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Jet Lag Type Insomnia
Lead sponsor: Vanda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2017-12-14
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Total Sleep Time in the First Two Thirds of the Night
timeFrame: 1 Day
Secondary outcomes:
measure: Total Sleep Time
timeFrame: 1 Day
measure: Latency to Persistent Sleep
timeFrame: 1 Day
measure: Wake After Sleep Onset
timeFrame: 1 Day
measure: Next Day Alertness as Measured by the Karolinska Sleepiness Scale (Night 1 Average Score)
timeFrame: 1 Day
measure: Next Day Alertness as Measured by the Visual Analogue Scale (Night 1 Average Score)
timeFrame: 1 Day
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Vanda Investigational Site
state: Arkansas
city: Alameda
country: United States
facility: Vanda Investigational Site
state: California
city: San Diego
country: United States
facility: Vanda Investigational Site
state: California
city: Santa Monica
country: United States
facility: Vanda Investigational Site
state: California
city: Oakland Park
country: United States
facility: Vanda Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Vanda Investigational Site
state: Georgia
city: Chevy Chase
country: United States
facility: Vanda Investigational Site
state: Maryland
city: Saint Louis
country: United States
facility: Vanda Investigational Site
state: Missouri
city: New York
country: United States
facility: Vanda Investigational Site
state: New York
city: Cincinnati
country: United States
facility: Vanda Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Vanda Investigational Site
state: Oklahoma
city: Houston
country: United States
facility: Vanda Investigational Site
state: Texas
Study officials:
References:
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.