Extension Study of Pimavanserin in Irritability Associated With Autism Spectrum Disorder

Irritability Associated With Autism Spectrum Disorder Clinical Trial

Official title:

A 52-Week Open-Label Extension Study of Pimavanserin in Children and Adolescents With Irritability Associated With Autism Spectrum Disorder (ASD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05555615
• Other study ID #: ACP-103-070
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: November 2, 2022
• Est. completion date: July 2025

Study information

• Verified date: June 2024
• Source: ACADIA Pharmaceuticals Inc.
• Contact: Sharon Ortiz
• Phone: 646-397-7336
• Email: Sharon.Ortiz[@]acadia-pharm.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Recruiting
• Enrollment: 228
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

INCLUSION CRITERIA:

• Has completed the treatment period of study ACP-103-069
• Informed consent prior to the conduct of any study procedures
• Continues to be both clinically stable and not at imminent risk of suicide or injury to self, others, or property
• Continues to be medically stable at enrollment
• For female patients only: unable to become pregnant or agree to use a highly effective non-hormonal method of contraception. Females of childbearing potential must have a negative pregnancy test

EXCLUSION CRITERIA:

• Patient or parent/legally accepted representative is judged by the Investigator to be inappropriate for the study
• Requires treatment with a medication prohibited by the protocol, including concomitant psychotropic drugs targeting irritability, including those used off-label (clonidine, guanfacine, and propranolol; lithium, valproate), medications that prolong the QT interval; and strong cytochrome P450 (CYP) 3A4 enzyme (CYP3A4) inhibitors and inducers
• At a significant risk of suicide, or is a danger to self or others
• At risk of significant violent behavior to the extent that participation would pose an undue risk to other patients, caregivers, or others
• Positive urine drug test
• Serious and/or unstable psychiatric, neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies
• Any change in medical or treatment status that may increase the risk associated with taking pimavanserin, would interfere with safety assessments, or would confound the interpretation of study results
• Clinically significant abnormal ECG of protocol-defined cardiac conduction abnormalities
• Weight <15 kg
• Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Irritability Associated With Autism Spectrum Disorder

Intervention

Drug:
• Pimavanserin
Pimavanserin given once daily, as capsule of 10, 20, or 34 mg dose strength, respectively, according to the patient's age

Locations

Country	Name	City	State
France	Centre Hospitalier Charles Perrens	Bordeaux
France	CHU de Nantes	Nantes
France	L'Assistance Publique - Hôpitaux de Paris, labélisé Institut Carnot	Paris
Hungary	Magyarországi Református Egyház Bethesda Gyermekkórháza	Budapest
Hungary	Békés Megyei Központi Kórház	Gyula
Hungary	Szegedi Tudományegyetem	Szeged
Italy	La Nostra Famiglia - Scientifica IRCCS Eugenio Medea	Bosisio Parini	LC
Italy	Policlinico Riuniti - Azienda Ospedaliero Universitaria	Foggia
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
Poland	Centrum Badan Klinicznych PI-House Sp. z o.o.	Gdansk
Poland	Gdanskie Centrum Zdrowia Sp. z o.o.	Gdansk
Poland	NAVICULA - Centrum Diagnozy i Terapii Autyzmu	Lodz
Poland	Centrum Neuropsychiatrii Neuromed SP ZOZ	Wroclaw
Poland	Ginemedica Sp. Zoo, S. K.	Wroclaw
Poland	MedicMental Indywidualna Specjalistyczna Praktyka Lekarska Monika Szewczuk-Boguslawska	Wroclaw
Spain	Hospital General de Alicante	Alicante
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Institut Global d´Atenció Integral del Neurodesenvolupament (IGAIN)	Barcelona
United States	Quest Therapeutics of Avon Lake dba Haidar Almhana Nieding LLC	Avon Lake	Ohio
United States	1st Allergy and Clinical Research Group, d/b/a IMUNOe Research Centers	Centennial	Colorado
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Relaro Medical Trials, LLC	Dallas	Texas
United States	Eastside Therapeutic Resource, Inc. dba Core Clinical Research	Everett	Washington
United States	The EHS Medical Practice, PA, D/B/A Sarkis Clinical Trials	Gainesville	Florida
United States	Cortica Inc. (Glendale)	Glendale	California
United States	Red Oak Psychiatry Associates, PA	Houston	Texas
United States	Clinical Research of Southern Nevada, LLC	Las Vegas	Nevada
United States	AMR Baber Research Incorporated	Naperville	Illinois
United States	APG Research, LLC	Orlando	Florida
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Southwest Autism Research and Resource Center	Phoenix	Arizona
United States	AIM Trials, LLC	Plano	Texas
United States	Cortica Inc.	San Rafael	California
United States	ERG Clinical Research - New York, PLLC DBA Richmond Behavioral Associates	Staten Island	New York
United States	Children's Research Institute	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
ACADIA Pharmaceuticals Inc.

Countries where clinical trial is conducted

United States,  France,  Hungary,  Italy,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment-emergent adverse events	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.	52 weeks
Secondary	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.	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.	52 weeks