A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pimavanserin for the Treatment of Irritability Associated With Autism Spectrum Disorder
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Not specified
- Sponsor
- ACADIA Pharmaceuticals Inc.
- Enrollment
- 237
- Locations
- 57
- Primary Endpoint
- Change From Baseline at Week 6 in Caregiver-rated Aberrant Behavior Checklist Irritability (ABC-I) Subscale Score
- Status
- Completed
- Last Updated
- 8 months ago
Overview
Brief Summary
6-week, randomized, double-blind, fixed-dose, placebo-controlled, parallel group study in children and adolescents (aged 5 to17 years) with autism spectrum disorder (ASD) with irritability, agitation, or self-injurious behaviors to study the efficacy and safety of pimavanserin
Detailed Description
This study will be conducted as a 6-week, randomized, double-blind, fixed-dose, placebo-controlled, parallel group study in children and adolescents (5 through 17 years of age) with ASD with irritability, agitation, or self-injurious behaviors.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Placebo
Placebo given once daily, as one capsule matching in size and color the respective pimavanserin treatment
Intervention: Placebo
Pimavanserin low dose
Patients aged 5 to 12 years: 10 mg/day pimavanserin Patients aged 13 to 17 years: 20 mg/day pimavanserin Pimavanserin given once daily, as capsule of 10 or 20 mg dose strength, respectively, according to the patient's age
Intervention: Pimavanserin
Pimavanserin high dose
Patients aged 5 to 12 years: 20 mg/day pimavanserin Patients aged 13 to 17 years: 34 mg/day pimavanserin Pimavanserin given once daily, as capsule of 20 or 34 mg dose strength, respectively, according to the patient's age
Intervention: Pimavanserin
Outcomes
Primary Outcomes
Change From Baseline at Week 6 in Caregiver-rated Aberrant Behavior Checklist Irritability (ABC-I) Subscale Score
Time Frame: 6 weeks
The Aberrant Behavior Checklist (ABC) is a caregiver-rated scale comprised of 5 empirically-derived subscales encompassing 58 items that describe various behavior problems. It measures domains of irritability, lethargy/social withdrawal, stereotypic behavior, hyperactivity/noncompliance, and inappropriate speech. ABC-I is one of the subscales and comprises of 15 items. Minimum score is 0, maximum is 45. A score for each item ranges from 0 indicating "not at all a problem" to 3 indicating "the problem is severe in degree". Subscale scores are calculated by summing the items within that subscale. Higher scores indicate greater impairment.