Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
ACADIA Pharmaceuticals Inc.
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).
Age
5–18
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Extension Study of Pimavanserin in Irritability Associated With Autism Spectrum Disorder
