Evaluating the Effects of Tasimelteon Vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD) and the CRY1Δ11 Variant
NCT ID: NCT06701396
Last Updated: 2024-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
60 participants
INTERVENTIONAL
2024-10-08
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Tasimelteon
Tasimelteon
Oral capsule
Placebo
Placebo
Oral capsule
Interventions
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Tasimelteon
Oral capsule
Placebo
Oral capsule
Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnancy, recent pregnancy (within 6 weeks), or women who are breastfeeding.
* A positive test for substances of abuse.
* Current tobacco user.
18 Years
75 Years
ALL
No
Sponsors
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Vanda Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Vanda Investigational Site
Çankaya, Ankara, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Vanda Pharmaceuticals Inc.
Role: primary
Other Identifiers
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VP-VEC-162-3501
Identifier Type: -
Identifier Source: org_study_id
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