A Target Engagement Study of Pimavanserin for Behavioral Inflexibility With Open Label Trial for Rigid Rigid-compulsive Behavior in Adolescents and Adults With Autism
This Phase 2 study examines the safety, tolerability, and preliminary efficacy of pimavanserin in individuals with Autism Spectrum Disorder. Male or female participants aged 12 to 40 years of age will be randomized to receive single doses of either placebo or pimavanserin in this randomized, placebo-controlled, cross-over designed study, followed by open label extension.
• Participant must be at least 12 years old and no greater than 40 years old.
• Participants 18 years of age or older or a legally acceptable representative must be able and willing to sign an informed consent document indicating understanding of the protocol and procedures and willingness to participate in full. For a participant who is under 18 years of age, a parent or guardian must sign an informed consent document indicating understanding the protocol and procedures and willingness to participate in full. When appropriate to the participants developmental level and age, assent will be used to indicate understanding and willingness to participant. If the participant is unable to sign the assent form, the participant must provide verbal or non-verbal confirmation of willingness to continue with study procedures. Each site will abide by their respective institutional requirements regarding consent of adult informants. For adult participants at the New York site only, a parent, caregiver, or other adult informant must sign an informed consent document indicating understanding the requirements for completing their portion of the study and their willingness to participate, due to institutional human subjects requirements.
• Participant must have a diagnosis of Autism Spectrum Disorder, according to DSM-5 criteria, made by a licensed study psychiatrist or psychologist and supported by the Autism Diagnostic Observation Schedule 2 (ADOS-2) completed at screening or within the past 12 months prior to screening by an appropriately trained professional.
• Participant must have a Clinical Global Impression of Severity for Repetitive Behavior of 4 or greater, as rated by the study psychiatrist or psychologist at Screening and at Baseline
• Participant must have a non-verbal IQ of greater than or equal to 70 as determined by the 4-subtest Wechsler Abbreviated Scale of Intelligence.
• Participant must be able to speak and understand English in order to complete study measures.
• Participant must live with a parent, primary caregiver, or other adult informant who can complete study measures on the basis of spending an average of at least 4 hours per day with the participant
• Parent, primary caregiver, or other adult informant must speak and understand English in order to complete study measures.
• Participant must be able to self-administer study medication or have parent/caregiver be able to administer study medication.
• Participant must be able to swallow study medication whole with liquid.
• Participant or legally acceptable representative must be willing to continue current medication(s) and behavioral intervention(s) and to not add or change medication(s) or behavioral intervention(s) over the full course of the study.