Irritability Associated With Autism Spectrum Disorder (ASD) Clinical Trial
— AnchorOfficial title:
A Phase 3, Multicenter, Randomized, Double-blind, Placebo Controlled Trial of Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder
| Verified date | August 2023 |
| Source | Otsuka Pharmaceutical Development & Commercialization, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to find out about the potential benefits and safety of brexpiprazole in children and adolescent participants, aged 5 to 17, with irritability associated with autism spectrum disorder.
| Status | Completed |
| Enrollment | 119 |
| Est. completion date | September 7, 2022 |
| Est. primary completion date | August 8, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 5 Years to 17 Years |
| Eligibility | Key Inclusion Criteria: - Primary Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of ASD - Aberrant Behavior checklist - Irritability (ABC-I) subscale score of = 18 - Clinical Global Impressions - Severity (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, and post-traumatic stress disorder (PTSD). Attention-deficit/hyperactivity disorder (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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | For additional information regarding sites | Princeton | New Jersey |
| Lead Sponsor | Collaborator |
|---|---|
| Otsuka Pharmaceutical Development & Commercialization, Inc. | H. Lundbeck A/S |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The mean change from baseline to Week 8 in the Aberrant Behavior Checklist- Irritability subscale score (ABC-I) | From baseline to Week 8 visit | ||
| Secondary | The mean change from baseline to Week 8 in the Clinical Global Impression- Severity of Illness Scale (CGI-S) score pertaining to irritability | From baseline to Week 8 visit |