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
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
Quest Therapeutics of Avon Lake dba Haidar Almhana Nieding LLC
🇺🇸Avon Lake, Ohio, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
The Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Relaro Medical Trials, LLC
🇺🇸Dallas, Texas, United States
Red Oak Psychiatry Associates, PA
🇺🇸Houston, Texas, United States
AIM Trials, LLC
🇺🇸Plano, Texas, United States
Eastside Therapeutic Resource, Inc. dba Core Clinical Research
🇺🇸Everett, Washington, United States
Children's Health Queensland Hospital and Health Service
🇦🇺South Brisbane, QDL, Australia
Monash Health
🇦🇺Clayton, Victoria, Australia
Murdoch Children's Research Institute
🇦🇺Parkville, Victoria, Australia
Centre Hospitalier Charles Perrens
🇫🇷Bordeaux, France
Centre de Ressources Autisme Rhône-Alpes - Center Hospitalier le Vinatier
🇫🇷Bron, France
CHU de Nantes
🇫🇷Nantes, France
L'Assistance Publique - Hôpitaux de Paris, labélisé Institut Carnot
🇫🇷Paris, France
Vadaskert Hospital
🇭🇺Budapest, Hungary
Magyarországi Református Egyház Bethesda Gyermekkórháza
🇭🇺Budapest, Hungary
Békés Megyei Központi Kórház
🇭🇺Gyula, Hungary
Szegedi Tudományegyetem
🇭🇺Szeged, Hungary
Azienda Ospedaliero Universitaria (AOU) Consorziale Policlinico
🇮🇹Bari, Italy
La Nostra Famiglia - Scientifica IRCCS Eugenio Medea
🇮🇹Bosisio Parini, Italy
The Childhood and Adolescence Neuropsychiatry Clinic - University of Cagliari and Pediatric Hospital "A. Cao" - ASL 8 of Cagliari
🇮🇹Cagliari, Italy
Policlinico Riuniti - Azienda Ospedaliero Universitaria
🇮🇹Foggia, Italy
IRCCS Istituto Giannina Gaslini
🇮🇹Genova, Italy
Azienda Ospedaliera Universitaria "Federico II"
🇮🇹Napoli, Italy
Fondazione Istituto Neurologico Nazionale Casimiro Mondino - IRCCS
🇮🇹Pavia, Italy
Fondazione PTV - Policlinico Tor Vergata
🇮🇹Roma, Italy
IRCCS Ospedale Pediatrico Bambino Gesù
🇮🇹Rome, Italy
Azienda Ospedaliera-Universitaria Senese
🇮🇹Siena, Italy
Azienda Ospedaliera Universitaria Integrata di Verona (AOUI)
🇮🇹Verona, Italy
Centrum Badań Klinicznych PI-House Sp. z o.o.
🇵🇱Gdansk, Poland
Gdańskie Centrum Zdrowia Sp. z o.o.
🇵🇱Gdańsk, Poland
Ginemedica Sp. Zoo, S.K.
🇵🇱Wrocław, Poland
Centrum Neuropsychiatrii NEUROMED SP ZOZ
🇵🇱Wrocław, Poland
MedicMental Indywidualna Specjalistyczna Praktyka Lekarska Monika Szewczuk-Boguslawska
🇵🇱Wrocław, Poland
NAVICULA - Centrum Diagnozy i Terapii Autyzmu
🇵🇱Łódź, Poland
Institute of Mental Health
🇷🇸Belgrade, Serbia
University Clinical Center Kragujevac, Clinic for Psychiatry
🇷🇸Kragujevac, Serbia
University Clinical Center Nis, Center for Mental Health
🇷🇸Nis, Serbia
Hospital General de Alicante
🇪🇸Alicante, Spain
Clinical Center of Vojvodina, Clinic for Psychiatry
🇷🇸Novi Sad, Serbia
Institut Global d´Atenció Integral del Neurodesenvolupament (IGAIN)
🇪🇸Barcelona, Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Clínic de Barcelona
🇪🇸Barcelona, Spain
Complejo Asistencial Universitario de Burgos
🇪🇸Burgos, Spain
Hospital Universitario Infanta Leonor
🇪🇸Madrid, Spain
Complejo Asistencial de Zamora
🇪🇸Zamora, Spain