Extension Study of Pimavanserin in Irritability Associated With Autism Spectrum Disorder
- Conditions
- Irritability Associated With Autism Spectrum Disorder
- Interventions
- Registration Number
- NCT05555615
- Lead Sponsor
- ACADIA Pharmaceuticals Inc.
- Brief Summary
52-week, open-label extension study of double-blind study ACP-103-069 to determine the long-term safety and tolerability of pimavanserin for the treatment of irritability associated with ASD in children and adolescents (aged 5 to 17 years).
ACP-103-069 is a 6-week, randomized, double-blind, fixed-dose, placebo controlled, parallel group study of pimavanserin in children and adolescents with irritability associated with autism spectrum disorder (ASD).
- Detailed Description
This study will be conducted as a 52-week, open-label extension study of the antecedent double-blind study to determine the long-term safety and tolerability of pimavanserin for the treatment of irritability associated with ASD in children and adolescents (5 through 17 years old at the time of enrolling into the antecedent double-blind study).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 209
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pimavanserin Pimavanserin Pimavanserin once daily. All patients will receive the pimavanserin low dose (patients aged 5 to 12 years: 10 mg/day pimavanserin; patients aged 13 to 17 years: 20 mg/day) the first 2 weeks of the study. Thereafter, the dose may be increased to the high dose (5 to 12 years: 20 mg/day; 13 to 17 years: 34 mg/day) based on the Investigator's assessment of clinical response. After Week 2 and up to Week 20, dose adjustments are allowed at any clinic visit based on the Investigator's assessment of clinical response and tolerability. No further dose adjustments are allowed after Week 20.
- Primary Outcome Measures
Name Time Method Treatment-emergent adverse events 52 weeks Number of Subjects With Adverse Events (AEs), Discontinuations Due to AEs and Serious AEs (SAEs) over 52 weeks of treatment. The Safety population consists of all subjects who received at least one dose of study drug in this study.
- Secondary Outcome Measures
Name Time Method Evaluate the continued response to long-term pimavanserin treatment in children and adolescents with irritability associated with ASD, defined by a composite endpoint of ABC-I and CGI-I response. 52 weeks Evaluate the continued response to long-term pimavanserin treatment in children and adolescents with irritability associated with ASD as assessed by a composite of a reduction in the Aberrant Behavior Checklist-Irritability (ABC-I) subscale score from baseline combined with a reduction in Clinical Global Impression-Improvement (CGI-I) of irritability score from baseline.
Trial Locations
- Locations (48)
Southwest Autism Research and Resource Center
🇺🇸Phoenix, Arizona, United States
Cortica Inc. (Glendale)
🇺🇸Glendale, California, United States
Cortica Inc.
🇺🇸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, 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, Queensland, 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
Magyarországi Református Egyház Bethesda Gyermekkórháza
ðŸ‡ðŸ‡ºBudapest, Hungary
Békés Megyei Központi Kórház
ðŸ‡ðŸ‡ºGyula, Hungary
Szegedi Tudományegyetem
ðŸ‡ðŸ‡ºSzeged, Hungary
La Nostra Famiglia - Scientifica IRCCS Eugenio Medea
🇮🇹Bosisio Parini, LC, Italy
Policlinico Riuniti - Azienda Ospedaliero Universitaria
🇮🇹Foggia, Italy
Azienda Ospedaliera Universitaria "Federico II"
🇮🇹Napoli, Italy
Fondazione Istituto Neurologico Nazionale Casimiro Mondino - IRCCS
🇮🇹Pavia, Italy
Fondazione PTV - Policlinico Tor Vergata
🇮🇹Rome, Italy
Azienda Ospedaliera Universitaria Integrata di Verona (AOUI)
🇮🇹Verona, Italy
Gdańskie Centrum Zdrowia Sp. z o.o.
🇵🇱Gdańsk, Poland
Centrum Badań Klinicznych PI-House Sp. z o.o.
🇵🇱Gdańsk, Poland
NAVICULA - Centrum Diagnozy i Terapii Autyzmu
🇵🇱Lodz, 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
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
Clinical Center of Vojvodina, Clinic for Psychiatry
🇷🇸Novi Sad, Serbia
Hospital General de Alicante
🇪🇸Alicante, Spain
Institut Global d´Atenció Integral del Neurodesenvolupament (IGAIN)
🇪🇸Barcelona, Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital ClÃnic de Barcelona
🇪🇸Barcelona, Spain