Extension Study of Pimavanserin in Irritability Associated With Autism Spectrum Disorder
Irritability Associated With Autism Spectrum Disorder
About this trial
This is an interventional treatment trial for Irritability Associated With Autism Spectrum Disorder
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; stimulant and non-stimulant medications), 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.
Sites / Locations
- Southwest Autism Research and Resource CenterRecruiting
- Cortica Inc.Recruiting
- Cortica Inc.Recruiting
- 1st Allergy and Clinical Research Group, d/b/a IMUNOe Research CentersRecruiting
- Children's Research InstituteRecruiting
- The EHS Medical Practice, PA, D/B/A Sarkis Clinical TrialsRecruiting
- APG Research, LLCRecruiting
- AMR Baber Research IncorporatedRecruiting
- Clinical Research of Southern Nevada, LLCRecruiting
- ERG Clinical Research - New York, PLLC DBA Richmond Behavioral Associates
- Quest Therapeutics of Avon Lake dba Haidar Almhana Nieding LLC
- Cincinnati Children's Hospital Medical CenterRecruiting
- Relaro Medical Trials, LLCRecruiting
- Red Oak Psychiatry Associates, PARecruiting
- Eastside Therapeutic Resource, Inc. dba Core Clinical ResearchRecruiting
- CHU de NantesRecruiting
- L'Assistance Publique - Hôpitaux de Paris, labélisé Institut CarnotRecruiting
- Magyarországi Református Egyház Bethesda GyermekkórházaRecruiting
- La Nostra Famiglia - Scientifica IRCCS Eugenio MedeaRecruiting
- Policlinico Riuniti - Azienda Ospedaliero UniversitariaRecruiting
- Fondazione Istituto Neurologico Nazionale Casimiro Mondino - IRCCSRecruiting
- Gdańskie Centrum Zdrowia Sp. z o.o.Recruiting
- Centrum Badań Klinicznych PI-House Sp. z o.o.Recruiting
- Ginemedica Sp. Zoo, S. K.Recruiting
- Centrum Neuropsychiatrii Neuromed SP ZOZRecruiting
- MedicMental Indywidualna Specjalistyczna Praktyka Lekarska Monika Szewczuk-BoguslawskaRecruiting
Arms of the Study
Arm 1
Experimental
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.