Pimavanserin for the Treatment of Irritability Associated with Autism Spectrum Disorder

Phase 2

Completed

• Conditions: Irritability Associated with Autism Spectrum Disorder
• Interventions: Drug: Placebo; Drug: Pimavanserin

• 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.

Study Timeline

• Study Start: 2022-08-09
• Study First Submitted: 2022-08-29
• Study First Submitted QC: 2022-08-29
• Study First Posted: 2022-08-31
• Status Verified: 2024-08
• Primary Completion: 2024-09-27
• Study Completion: 2024-09-27
• Last Update Submitted: 2024-11-08
• Last Update Posted: 2024-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 237

Inclusion Criteria

Not provided

Exclusion Criteria

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

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

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