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

Vanda Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Jet Lag Disorder

Treatments: Drug: Tasimelteon; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03291041

VP-VEC-162-2102

Details and patient eligibility

About

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

Enrollment: 25 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25 participants in 2 patient groups, including a placebo group

tasimelteon

Experimental group

Description:

tasimelteon, administered as oral capsule(s)

Treatment:

Drug: Tasimelteon

Placebo

Placebo Comparator group

Description:

Placebo, administered as oral capsule(s)

Treatment:

Drug: Placebo