NCT01218789Phase 3Unknown

Safety Study of Tasimelteon for Treatment of Non-24-Hour-Sleep-Wake Disorder in Blind Individuals With No Light Perception

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2024-12-05Estimated

Enrollment · participants140Estimated

Source updated2024-04-03Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Non 24 Hour Sleep Wake Disorder

Treatments or interventions studied

tasimelteonDrugAlso known as VEC-162

Primary outcomes · main study measures

Read the study measures

measure: Safety Evaluations; description: the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs). The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.; timeFrame: Week 4; measure: Safety Evaluations; description: the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs). The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.; timeFrame: Week 8; measure: Safety Evaluations; description: the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs). The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.; timeFrame: Week 12; measure: Safety Evaluations; description: the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs). The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.; timeFrame: Week 16; measure: Safety Evaluations; description: the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs). The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.; timeFrame: Week 26; measure: Safety Evaluations; description: the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs). The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.; timeFrame: Week 34; measure: Safety Evaluations; description: the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs). The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.; timeFrame: Week 42; measure: Safety Evaluations; description: the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs). The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.; timeFrame: Week 52

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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