Other Clinical Trial - Brexpiprazole in Treatment of Children &

Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder for Subjects That Have Completed Participation in 331-201-00148

Irritability Associated With Autism Spectrum Disorder Clinical Trial

Official title:
A Phase 3, Multicenter, Open Label Trial to Evaluate the Long-term Safety and Tolerability of Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

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

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05555615` - Extension Study of Pimavanserin in Irritability Associated With Autism Spectrum Disorder	Phase 2/Phase 3
Terminated	`NCT05733390` - A Study of JZP541 in Adults With Irritability Associated With Autism Spectrum Disorder	Phase 2
Recruiting	`NCT05523895` - Pimavanserin for the Treatment of Irritability Associated With Autism Spectrum Disorder	Phase 2/Phase 3

See also

Status

Clinical Trial

Phase

Recruiting

NCT05555615 - Extension Study of Pimavanserin in Irritability Associated With Autism Spectrum Disorder

Phase 2/Phase 3

Terminated

NCT05733390 - A Study of JZP541 in Adults With Irritability Associated With Autism Spectrum Disorder

Phase 2

Recruiting

NCT05523895 - Pimavanserin for the Treatment of Irritability Associated With Autism Spectrum Disorder

Phase 2/Phase 3

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT04258839
Study type	Interventional
Source	Otsuka Pharmaceutical Development & Commercialization, Inc.
Contact
Status	Completed
Phase	Phase 3
Start date	January 23, 2020
Completion date	March 16, 2023

Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder for Subjects That Have Completed Participation in 331-201-00148

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms