A Target Engagement Study of Pimavanserin for Behavioral Inflexibility With Open Label Trial for Rigid Rigid-compulsive Behavior in Adolescents and Adults With Autism
New York State Psychiatric Institute
Summary
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.
Description
The goal of this clinical trial is to learn the safety, tolerability and to assess pimavanserin for effects on behavioral rigidity and rigid-compulsive behavior in adolescents and adults with Autism Spectrum Disorder. Participants who meet protocol criteria will be randomly assigned to receive either pimavanserin or placebo in a 1:1 ratio in the Treatment Period. After completing the second experimental day of the cross-over trial, participants will immediately enter the Open-Label Trial, where they will take pimavanserin 34 mg for six weeks total. There will be 2 recruiting sites with a tota…
Eligibility
- Age range
- 12–40 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 ag…
Interventions
- DrugPimavanserin Tartrate 34 Mg ORAL CAPSULE [NUPLAZID]
Participants will be randomized to take a single dose of either pimavanserin 34 mg or placebo at Visit 2.
- DrugPlacebo
Placebo for Pimavanserin Tartrate 34 Mg ORAL CAPSILE \[NUPLAZID\]
Locations (2)
- University of Kansas, Center for ResearchLawrence, Kansas
- Center for Autism and the Developing BrainWhite Plains, New York