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

• Status: Enrolling by invitation
• Trial end date: 2022-08-20
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the long-term safety and tolerability of brexpiprazole in children and adolescent patients, aged 5 to 17, with irritability associated with autism spectrum disorder.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Collaborator: H. Lundbeck A/S
• Treatments: Brexpiprazole

Criteria

Inclusion Criteria:

• 5 to 17 year of age or turned 18 while enrolled in the 331-201-00148 study

• Autism Spectrum Disorder

• Completion of 331-201-00148 trial

• Investigator assessment

Exclusion Criteria:

• Did not complete treatment period or incurred significant protocol deviations during 331-201-00148 study

• Sexually active males or female of childbearing potential who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose

• Female with positive pregnancy test