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

Vanda Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Jet Lag Type Insomnia

Treatments: Drug: Tasimelteon; Drug: Placebo

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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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320 participants in 2 patient groups, including a placebo group

Tasimelteon

Experimental group

Treatment:

Drug: Tasimelteon

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo