Children and adolescents, ages 3-17, who are diagnosed with Autism Spectrum Disorder (ASD) or Smith-Magenis Syndrome (SMS) and have a nighttime sleep complaint or who are legally blind and have sleep-wake symptoms of Non-24-hour Sleep-Wake Disorder are needed for a clinical trial. The purpose of this is to determine an age-appropriate dose and to assess the safety/tolerability of a single dose of an investigational drug for children and adolescents ages 3-17 years. The investigational drug is currently approved by the United States Food and Drug Administration (FDA) for another indication in adults
Study participation will last up to 2 consecutive days. The study can accommodate families on both weekdays and weekends; scheduling is flexible. The study sponsor will cover the costs of you/your child’s travel to and from the study clinic, and travel arrangements are made for you by the clinical site. The study-related blood/urine tests and physical exam are provided at no cost to families. You and your child will receive remuneration for your time and participation.
An initial pre-screen questionnaire, completed over the phone, will be needed to determine eligibility to travel to the clinic and complete the screening assessment at the clinic. The screening assessment at the clinic (1st day of study) will determine eligibility to receive a single dose of the study medication on the 2nd day.
To complete the initial pre-screen questionnaire please call 818-254-1983 or click ‘Apply For This Study’ below.