Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder

• Status: Recruiting
• Trial end date: 2022-02-23
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to find out about the potential benefits and safety of brexpiprazole in children and adolescent subjects, 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

Key Inclusion Criteria:

• Primary DSM-5 diagnosis of Autism Spectrum Disorder

• ABC-I subscale score of ≥ 18

• CGI-S scale score pertaining to irritability ≥ 4

• Mental age of ≥ 2 years as determined by Investigator based upon school participation, social history or medical records

• Ability for parent/caregiver to follow all protocol procedures

• Able to swallow tablets

• Able to discontinue all prohibited concomitant medications to meet protocol required washouts prior to and during the trial period

Key Exclusion Criteria:

• Primary diagnosis of bipolar I disorder, including any DSM-5 current diagnosis of bipolar II disorder, schizophrenia, schizoaffective disorder, major depressive episode, PTSD. ADHD maybe exclusionary if it is the primary disorder, or is not stable or adequately treated.

• current or historical diagnosis of Fragile-X Syndrome or Rett's Disorder

• history of neuroleptic malignant syndrome

• a significant risk of committing violent acts, serious self-harm, or suicide

• epilepsy, a history of seizures, or a history of severe head trauma or stroke, or have a history or current evidence of other unstable medical conditions

• current hypothyroidism or hyperthyroidism

• uncontrolled Type I or Type II diabetes

• uncontrolled hypertension or symptomatic hypotension, or orthostatic hypotension

• Weight < 15 kg

• Previous exposure to brexpiprazole

• Sexually active males or females, who could become pregnant, not agreeing to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days at the end of the study