Clinical trial NCT05555615: Extension Study of Pimavanserin in Irritability Associated With Autism Spectrum Disorder
Official title: A 52-Week Open-Label Extension Study of Pimavanserin in Children and Adolescents With Irritability Associated With Autism Spectrum Disorder (ASD)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Irritability Associated With Autism Spectrum Disorder
Lead sponsor: ACADIA Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2022-09-27
Enrollment: 209
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Treatment-emergent adverse events
timeFrame: 52 weeks
Secondary outcomes:
measure: 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.
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Southwest Autism Research and Resource Center
state: Arizona
city: Glendale
country: United States
facility: Cortica Inc. (Glendale)
state: California
city: San Rafael
country: United States
facility: Cortica Inc.
state: California
city: Centennial
country: United States
facility: 1st Allergy and Clinical Research Group, d/b/a IMUNOe Research Centers
state: Colorado
city: Washington
country: United States
facility: Children's Research Institute
state: District of Columbia
city: Gainesville
country: United States
facility: The EHS Medical Practice, PA, D/B/A Sarkis Clinical Trials
state: Florida
city: Orlando
country: United States
facility: APG Research, LLC
state: Florida
city: Naperville
country: United States
facility: AMR Baber Research Incorporated
state: Illinois
city: Las Vegas
country: United States
facility: Clinical Research of Southern Nevada, LLC
state: Nevada
city: Staten Island
country: United States
facility: ERG Clinical Research - New York, PLLC DBA Richmond Behavioral Associates
state: New York
city: Avon Lake
country: United States
facility: Quest Therapeutics of Avon Lake dba Haidar Almhana Nieding LLC
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Dallas
country: United States
facility: Relaro Medical Trials, LLC
state: Texas
city: Houston
country: United States
facility: Red Oak Psychiatry Associates, PA
state: Texas
city: Plano
country: United States
facility: AIM Trials, LLC
state: Texas
city: Everett
country: United States
facility: Eastside Therapeutic Resource, Inc. dba Core Clinical Research
state: Washington
city: South Brisbane
country: Australia
facility: Children's Health Queensland Hospital and Health Service
state: Queensland
city: Clayton
country: Australia
facility: Monash Health
state: Victoria
city: Parkville
country: Australia
facility: Murdoch Children's Research Institute
state: Victoria
city: Bordeaux
country: France
facility: Centre Hospitalier Charles Perrens
city: Bron
country: France
facility: Centre de Ressources Autisme Rhône-Alpes - Center Hospitalier le Vinatier
city: Nantes
country: France
facility: CHU de Nantes
city: Paris
country: France
facility: L'Assistance Publique - Hôpitaux de Paris, labélisé Institut Carnot
city: Budapest
country: Hungary
facility: Magyarországi Református Egyház Bethesda Gyermekkórháza
city: Gyula
country: Hungary
facility: Békés Megyei Központi Kórház
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem
city: Bosisio Parini
country: Italy
facility: La Nostra Famiglia - Scientifica IRCCS Eugenio Medea
state: LC
city: Foggia
country: Italy
facility: Policlinico Riuniti - Azienda Ospedaliero Universitaria
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria "Federico II"
city: Pavia
country: Italy
facility: Fondazione Istituto Neurologico Nazionale Casimiro Mondino - IRCCS
city: Rome
country: Italy
facility: Fondazione PTV - Policlinico Tor Vergata
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata di Verona (AOUI)
city: Gdańsk
country: Poland
facility: Gdańskie Centrum Zdrowia Sp. z o.o.
city: Gdańsk
country: Poland
facility: Centrum Badań Klinicznych PI-House Sp. z o.o.
city: Lodz
country: Poland
facility: NAVICULA - Centrum Diagnozy i Terapii Autyzmu
city: Wrocław
country: Poland
facility: Ginemedica Sp. Zoo, S. K.
city: Wrocław
country: Poland
facility: Centrum Neuropsychiatrii Neuromed SP ZOZ
city: Wrocław
country: Poland
facility: MedicMental Indywidualna Specjalistyczna Praktyka Lekarska Monika Szewczuk-Boguslawska
city: Belgrade
country: Serbia
facility: Institute of Mental Health
city: Kragujevac
country: Serbia
facility: University Clinical Center Kragujevac, Clinic for Psychiatry
city: Nis
country: Serbia
facility: University Clinical Center Nis, Center for Mental Health
city: Novi Sad
country: Serbia
facility: Clinical Center of Vojvodina, Clinic for Psychiatry
city: Alicante
country: Spain
facility: Hospital General de Alicante
city: Barcelona
country: Spain
facility: Institut Global d´Atenció Integral del Neurodesenvolupament (IGAIN)
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
Study officials:
References: