Evaluating the Effects of Tasimelteon Vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD) and the CRY1Δ11 Variant

Vanda Pharmaceuticals

Status and phase: Enrolling; Phase 3

Conditions: Sleep Disorders, Circadian Rhythm; Gene Mutations and Other Alterations Nec; Chronobiology Disorders; Sleep Wake Disorders

Treatments: Drug: Tasimelteon; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06701396

VP-VEC-162-3501

Details and patient eligibility

About

This is a double-blind, randomized, two-period crossover study to evaluate the efficacy and safety of a single oral dose of tasimelteon and matching placebo in male and female subjects with DSWPD and the CRY1Δ11 variant.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ability and acceptance to provide written informed consent.
• A confirmed clinical diagnosis of Delayed Sleep-Wake Phase Disorder (DSWPD).
• Carrier of CRY1Δ11 variant.
• Men or women between 18 - 75 years, inclusive.
• Body Mass Index (BMI) of ≥ 18 and ≤ 40 kg/m^2.

Exclusion criteria

• Major surgery, trauma, illness, general anesthesia, or immobility for 3 or more days within the last 30 days.
• Pregnancy, recent pregnancy (within 6 weeks), or women who are breastfeeding.
• A positive test for substances of abuse.
• Current tobacco user.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Tasimelteon

Experimental group

Treatment:

Drug: Tasimelteon

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo