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

Otsuka

Status and phase: Completed; Phase 3

Conditions: Irritability Associated With Autism Spectrum Disorder

Treatments: Drug: Brexpiprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT04258839

331-201-00191

2018-004899-35 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 95 patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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95 participants in 1 patient group

Brexpiprazole

Experimental group

Description:

Participants received brexpiprazole based on the body weight for 26 weeks in this study. Participants with body weight \< 50 kilograms (kg), received brexpiprazole tablets orally, once daily (QD) at dose of 0.25 mg on Days 1 to 3 followed by 0.5 mg on Days 4 to 7 and 1 mg on Days 8 to 14. Based on the investigator's judgment, the dose was increased to 1 or 1.5 mg starting from Day 15 until week 26. Participants with body weight ≥ 50 kg received brexpiprazole tablet orally, QD at dose of 0.5 mg on Days 1 to 3, followed by 1.5 mg on Days 4 to 7, and 2 mg on Days 8 to 14. Based on the investigator's judgment the dose was increased to 1.5, 2, or 3 mg starting from Day 15 until week 26.

Treatment:

Drug: Brexpiprazole