Pimavanserin for the Treatment of Irritability Associated with Autism Spectrum Disorder
- Conditions
- Irritability Associated with Autism Spectrum Disorder
- Interventions
- Drug: Placebo
- Registration Number
- NCT05523895
- Lead Sponsor
- ACADIA Pharmaceuticals Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 237
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo given once daily, as one capsule matching in size and color the respective pimavanserin treatment Pimavanserin low dose Pimavanserin 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 Pimavanserin high dose Pimavanserin 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
- Primary Outcome Measures
Name Time Method Change from Baseline at Week 6 in caregiver-rated Aberrant Behavior Checklist (ABC) Irritability subscale score 6 weeks The Aberrant Behavior Checklist (ABC) is a caregiver-rated scale comprised of five 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-Irritability is one of the subscales and comprises of 15 items. Minimum score is 0, maximum is 45. The ABC will be administered at Screening and Baseline, and at all post-Baseline visits from Week 1 through Week 6. 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.
- Secondary Outcome Measures
Name Time Method Change from Baseline at Week 6 in Clinical Global Impression-Severity (CGI-S) of Irritability score 6 weeks Change from Baseline at Week 6 in caregiver-rated ABC subscale scores: Stereotypic Behavior; Lethargy; Hyperactivity; Inappropriate speech 6 weeks Change from Baseline at Week 6 in Vineland Adaptive Behavior Scales (VABS)-Socialization subscale score 6 weeks Change from Baseline at Week 6 in Caregiver Strain Questionnaire (CGSQ) scores 6 weeks Proportion of patients with at least 25% reduction from Baseline in ABC-Irritability subscale score at Week 6 6 weeks Proportion of patients with CGI-I of irritability score of 1 (very much improved) or 2 (much improved) at Week 6 6 weeks Proportion of patients with at least 25% reduction from Baseline in ABC-Irritability subscale score and CGI-I of irritability score of 1 or 2 at Week 6 6 weeks Clinical Global Impression-Improvement (CGI-I) of irritability score at Week 6 6 weeks Change from Baseline at Week 6 in Repetitive Behavior Scale-Revised (RBS-R) scores 6 weeks
Related Research Topics
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Trial Locations
- Locations (57)
Southwest Autism Research & Resource Center
🇺🇸Phoenix, Arizona, United States
Cortica Inc. (Glendale)
🇺🇸Glendale, California, United States
Cortica Inc. (San Rafael)
🇺🇸San Rafael, California, United States
1st Allergy and Clinical Research Group, d/b/a IMUNOe Research Centers
🇺🇸Centennial, Colorado, United States
Children's Research Institute
🇺🇸Washington, D.C., District of Columbia, United States
The EHS Medical Practice, PA, D/B/A Sarkis Clinical Trials
🇺🇸Gainesville, Florida, United States
APG Research, LLC
🇺🇸Orlando, Florida, United States
AMR Baber Research Incorporated
🇺🇸Naperville, Illinois, United States
Clinical Research of Southern Nevada, LLC
🇺🇸Las Vegas, Nevada, United States
ERG Clinical Research - New York, PLLC DBA Richmond Behavioral Associates
🇺🇸Staten Island, New York, United States
Scroll for more (47 remaining)Southwest Autism Research & Resource Center🇺🇸Phoenix, Arizona, United States