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Clinical trial

A Study to Evaluate the Efficacy and Safety of Tasimelteon in Treating Sleep Disturbances in Individuals With Autism Spectrum Disorder

ID
Name
VP-VEC-162-3601
Description
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.
Trial arms
Trial start
2021-07-28
Estimated PCD
2025-07-01
Trial end
2025-07-01
Status
Recruiting
Phase
Early phase I
Treatment
Tasimelteon Oral Capsule, Tasimelteon Liquid Suspension
Once Daily
Arms:
Tasimelteon
Size
100
Primary endpoint
Change in sleep time over the treatment period, as measured by sleep diary.
12 weeks
Eligibility criteria
Inclusion Criteria: * Ability and acceptance to provide written informed consent of the participant or legal guardian (and assent as required). * A confirmed clinical diagnosis of Autism Spectrum Disorder (ASD) and a recent history of sleep disturbances. * The sleep disturbance must not be a result of another diagnosable disorder or medication. * Male or female between 2 and 65 years of age, inclusive. * Willing and able to comply with study requirements and restrictions. Exclusion Criteria: * Inability to dose daily with tasimelteon or previous intolerance to tasimelteon. * Indication of impaired liver function. * Evidence of increased risk of self-harm. * Pregnant or lactating females. * A positive test for drugs of abuse. * Other diagnosable causes of sleep disorders or use of medications that may cause sedation or stimulation.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2024-03-21

1 organization

1 product

4 indications

Organization
Vanda Pharmaceuticals
Product
Tasimelteon
Indication
Autism Spectrum Disorder
Indication
Sleep Disorder
Indication
Neurological Disorder
Indication
Sleep Disturbance