A Phase 3 interventional study of Tasimelteon Oral Capsule, Tasimelteon Liquid Suspension in Autism Spectrum Disorder, Sleep Disorder and Neurological Disorder, sponsored by Vanda Pharmaceuticals. Recruiting at 5 sites in United States. Open to participants aged 2 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-03-21.
Sponsored by Vanda Pharmaceuticals · Phase 3, Interventional, and Treatment
This is a multicenter, open-label study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon in treating sleep disturbances in pediatric and adult participants with ASD.
788 studies on the registry are indexed under Sleep Wake Disorders; 186 are open to participants now.
This study's planned enrollment of 100 is above the median of 62 across 548 interventional studies indexed under Sleep Wake Disorders.
Browse Sleep Wake Disorders studies →Vanda Pharmaceuticals is the lead sponsor of 81 studies on the registry; 18 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 22 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Tasimelteon
Drug: Tasimelteon Oral Capsule, Tasimelteon Liquid Suspension
Once Daily
Change in sleep time over the treatment period, as measured by sleep diary.
Time frame: 12 weeks
Improvement in objective sleep-wake parameters such as severity of condition, as measured by administered questionnaires.
Time frame: 12 weeks
Improvement in objective behavioral parameters such as the participant's overall behavior, as measured by sleep diary in the Patient Global Impression of Severity Behavior Questionnaire (PGI-S Behavior).
Time frame: 12 weeks
Assessment of safety and tolerability of daily single dose of tasimelteon, as measured by spontaneous reporting of adverse events (AEs).
Time frame: 12 weeks
Plan to share: No
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Vanda Pharmaceuticals