Extension Study of Pimavanserin in Irritability Associated With Autism Spectrum Disorder
Megadott ok: The study was terminated for business reasons and not due to safety concerns.
Key facts
- Where
- Budapest, Gyula és Szeged, MagyarországSee the 3 sites
- Phase
- 2/3. fázis
Where in Magyarország
- Magyarországi Református Egyház Bethesda GyermekkórházaBudapest, MagyarországNo longer taking part
- Bekes Megyei Kozponti KorhazGyula, MagyarországNo longer taking part
- Szegedi TudomanyegyetemSzeged, MagyarországNo longer taking part
Trial details
- Who runs it
- ACADIA Pharmaceuticals Inc.
- Trial code
- NCT05555615
- Record updated
- 2025. december 3.
- Original description
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).Read full original descriptionShow less
A 52-Week Open-Label Extension Study of Pimavanserin in Children and Adolescents With Irritability Associated With Autism Spectrum Disorder (ASD)
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).
Inclusion: 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: Positive urine drug test; Serious and/or unstable psychiatric, neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies; Clinically significant abnormal ECG of protocol-defined cardiac conduction abnormalities; 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; Patient or parent/legally accepted representative is judged by the Investigator to be inappropriate for the study; 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; 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; Weight <15 kg; Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.