NCT03373201

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2017

Shorter than P25 for phase_3

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 16, 2017

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

October 31, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 14, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2018

Completed
5.5 years until next milestone

Results Posted

Study results publicly available

September 15, 2023

Completed
Last Updated

September 15, 2023

Status Verified

September 1, 2023

Enrollment Period

5 months

First QC Date

October 31, 2017

Results QC Date

January 6, 2023

Last Update Submit

September 12, 2023

Conditions

Jet Lag Type Insomnia

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 Day

Secondary Outcomes (5)

  • Total Sleep Time

    1 Day

  • Latency to Persistent Sleep

    1 Day

  • Wake After Sleep Onset

    1 Day

  • Next Day Alertness as Measured by the Karolinska Sleepiness Scale (Night 1 Average Score)

    1 Day

  • Next Day Alertness as Measured by the Visual Analogue Scale (Night 1 Average Score)

    1 Day

Study Arms (2)

Tasimelteon

EXPERIMENTAL
Drug: Tasimelteon

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

TasimelteonDRUG

Oral capsule

Tasimelteon
PlaceboDRUG

Oral capsule

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Vanda Investigational Site

Little Rock, Arkansas, 72211, United States

Location

Vanda Investigational Site

Alameda, California, 94501, United States

Location

Vanda Investigational Site

San Diego, California, 92103, United States

Location

Vanda Investigational Site

Santa Monica, California, 90404, United States

Location

Vanda Investigational Site

Oakland Park, Florida, 33334, United States

Location

Vanda Investigational Site

Atlanta, Georgia, 30342, United States

Location

Vanda Investigational Site

Chevy Chase, Maryland, 20815, United States

Location

Vanda Investigational Site

St Louis, Missouri, 63141, United States

Location

Vanda Investigational Site

New York, New York, 10019, United States

Location

Vanda Investigational Site

Cincinnati, Ohio, 45212, United States

Location

Vanda Investigational Site

Oklahoma City, Oklahoma, 73112, United States

Location

Vanda Investigational Site

Houston, Texas, 77063, United States

Location

Related Publications (1)

  • 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.

    PMID: 32754110DERIVED

MeSH Terms

Interventions

tasimelteon

Results Point of Contact

Title
Medical Director
Organization
Vanda Pharmaceuticals
clinicaltrials@vandapharma.com
202-734-3400

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2017

First Posted

December 14, 2017

Study Start

October 16, 2017

Primary Completion

March 5, 2018

Study Completion

March 5, 2018

Last Updated

September 15, 2023

Results First Posted

September 15, 2023

Record last verified: 2023-09

Locations

US(12)