Evaluating the Effects of Tasimelteon vs. Placebo on Jet Lag Type Insomnia

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Vanda Pharmaceuticals

Status and phase

Completed
Phase 3

Conditions

Jet Lag Type Insomnia

Treatments

Drug: Placebo
Drug: Tasimelteon

Study type

Interventional

Funder types

Industry

Identifiers

NCT03373201
VP-VEC-162-3107

Details and patient eligibility

About

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.

Enrollment

320 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

320 participants in 2 patient groups, including a placebo group

Tasimelteon
Experimental group
Treatment:
Drug: Tasimelteon
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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