Brexpiprazole for Autism
(Anchor Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the potential benefits and safety of brexpiprazole, an antipsychotic, for children and teens with irritability linked to autism spectrum disorder (ASD). Researchers aim to determine if this treatment can reduce irritability in participants aged 5 to 17. The study compares brexpiprazole's effects to a placebo, which contains no active medication. Children and teens with an ASD diagnosis and noticeable irritability might be suitable for this study. Participants must be able to swallow tablets and follow trial procedures with a caregiver's assistance. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.
Will I have to stop taking my current medications?
Yes, you will need to stop taking certain medications before and during the trial, as the study requires a washout period (time without taking certain medications).
Is there any evidence suggesting that brexpiprazole is likely to be safe for children and adolescents with irritability associated with autism spectrum disorder?
Research has shown that brexpiprazole has been tested for safety in over 12,550 adults across various clinical trials for conditions like depression. These studies indicate it is generally well-tolerated. Common side effects include weight gain and sleepiness, while serious issues remain rare.
In long-term studies involving adults with schizophrenia, brexpiprazole was used safely for up to a year, with regular safety checks. Although this trial focuses on children and teens with autism, the existing data in adults offers some reassurance about its safety.
Brexpiprazole already has FDA approval for treating other conditions, indicating it has met certain safety standards. However, effects in children might differ, so ongoing trials are crucial to confirm safety for this group.12345Why do researchers think this study treatment might be promising?
Brexpiprazole is unique because it offers a new approach to managing irritability associated with Autism Spectrum Disorder (ASD) in children and adolescents. Unlike standard treatments such as risperidone or aripiprazole, which can have side effects like weight gain and sedation, brexpiprazole is designed to be a more tolerable option. It works by balancing dopamine and serotonin in the brain, which may help reduce irritability with fewer side effects. Researchers are excited about brexpiprazole because it could provide a more effective and safer alternative for young people with ASD.
What evidence suggests that brexpiprazole might be an effective treatment for irritability associated with autism?
Research has shown that brexpiprazole, which participants in this trial may receive, can help reduce irritability in conditions similar to autism. One study found that participants experienced a noticeable decrease in irritability. Additionally, it proved effective in calming agitation in people with Alzheimer's. These results suggest that brexpiprazole might help manage irritability in children and teenagers with autism spectrum disorder.46789
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive flexible doses of brexpiprazole or placebo up to Week 8
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Brexpiprazole
Brexpiprazole is already approved in United States, Canada, European Union, Japan, Brazil for the following indications:
- Major depressive disorder (as an adjunctive therapy to antidepressants)
- Schizophrenia
- Agitation associated with dementia due to Alzheimer's disease
- Major depressive disorder (as an adjunctive therapy to antidepressants)
- Schizophrenia
- Schizophrenia
- Schizophrenia
- Major depressive disorder (as an adjunctive therapy to antidepressants)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Otsuka Pharmaceutical Development & Commercialization, Inc.
Lead Sponsor
John Kraus
Otsuka Pharmaceutical Development & Commercialization, Inc.
Chief Medical Officer since 2023
MD, PhD
Tarek Rabah
Otsuka Pharmaceutical Development & Commercialization, Inc.
Chief Executive Officer since 2022
BS in Biology and BA in Business from the American University of Beirut, MBA from McGill University
H. Lundbeck A/S
Industry Sponsor
Charl van Zyl
H. Lundbeck A/S
Chief Executive Officer since 2023
Degree in Medical Biochemistry from the University of Cape Town, South Africa
Johan Luthman
H. Lundbeck A/S
Chief Medical Officer since 2019
MD from the University of Gothenburg, Sweden