2026-07-24
notable
Study Status, Contacts/Locations v9
Enrollment closed, study ongoing
Primary completion pushed: 2026-06 → 2026-09
Completion pushed: 2026-06 → 2026-09
Study sitesdetails revised at 17 of 17 sites
2025-11-24
minor
Study Identification, Study Status, Oversight, Contacts/Locations v8
Primary completion date2025-12→2026-06
Completion date2025-12→2026-06
Study sites21→17
Study titlerevised
Evaluating the Effects of Tasimelteon Vsvs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD)
2024-11-14
minor
Study Identification, Study Status, Oversight, Study Design, Eligibility, Contacts/Locations v7
Primary completion date2024-12→2025-12
Enrollment target300→70
Study sites18→21
Eligibility criteria+22 characters
[...] are breastfeeding.
A positive test for substances of abuse.
Current tobacco user.
Study titlerevised
Evaluating the Effects of Tasimelteon vsVs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD)
2024-04-01
minor
Study Status, Eligibility, Contacts/Locations v6
Primary completion date2022-12→2024-12
Completion date2023-12→2025-12
Study sites15→18
Eligibility criteria+71 characters
[...] ss Index (BMI) of ≥ 18 and ≤ 35 kg/m^2.
Exclusion Criteria:
HistoryExacerbation of an existing psychiatric disorderscondition withinthat 12requires change in treatment or intervention in the past 3 months.
Major surgery, trauma, illness, general anesthesia, [...]
2022-01-12
minor
Study Status, Eligibility, Contacts/Locations v5
Eligibility criteria-119 characters
Inclusion Criteria:
Ability and acceptance to provide written informed consent of the participant or legal guardian.
Participants ≥ 16 and < 18 years of age will also need to provide written assent.
A confirmed clinical diagnosis of Delayed Sleep-Wake Phase Disorder (DSWPD).
Men or women between 1618 - 75 years, inclusive.
Body Mass Index (BMI) of ≥ 18 and ≤ [...]
Study sitesdetails revised at 6 of 15 sites
Show 4 earlier versions
2021-10-15
minor
Study Status, Contacts/Locations v4
Primary completion date2021-12→2022-12
Completion date2022-12→2023-12
Study sites16→15
2021-06-11
minor
Study Status, Eligibility, Contacts/Locations v3
Eligibility criteriarevised
[...] leep-Wake Phase Disorder (DSWPD).
Men or women between 16 - 6575 years, inclusive.
Body Mass Index (BMI) of ≥ 18 and ≤ 3035 kg/m^2.
Exclusion Criteria:
History of psychiatric disorder [...]
2021-03-02
minor
Study Status, Eligibility, Contacts/Locations v2
Eligibility criteria+119 characters
Inclusion Criteria:
Ability and acceptance to provide written informed consent of the participant or legal guardian.
Participants ≥ 16 and < 18 years of age will also need to provide written assent.
A confirmed clinical diagnosis of Delayed Sleep-Wake Phase Disorder (DSWPD).
Men or women between 1816 - 65 years, inclusive.
Body Mass Index (BMI) of ≥ 18 and ≤ [...]
2021-01-14
minor
Study Status, Eligibility, Contacts/Locations v1
Start dateestimated 2020-12→confirmed 2020-12-09
Study sites8→9
Eligibility criteria-24 characters
[...] Criteria:
History of psychiatric disorders within 12 months (other than depression).
Major surgery, trauma, illness, general anesthesia, or imm [...]
2020-12-02
minor
Original filing