Study of Cariprazine Oral Capsules or Solution to Assess Adverse Events &

Status Recruiting

Clinical Trial Summary

Autism spectrum disorder (ASD) consists of deficits in social, communication, and cognitive development, repetitive and stereotypic behaviors. Many ASD patients show notably high levels of irritability, including verbal and physical aggression, self injury, and/or property destruction. Autistic infants tend to avoid eye contact and show little interest in others. This study will assess how safe and effective cariprazine is in treating pediatric participants (5 to 17 years of age) with ASD. Adverse events and change in disease activity will be assessed. Cariprazine is an investigational drug being developed for the treatment of irritability due to ASD. This study is double-blinded means that neither the participants nor the study doctors will know who will be given cariprazine and who will be given placebo (does not contain treatment drug). Study doctors put the participants in 1 of the 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. Approximately 152 participants diagnosed with ASD will be enrolled in approximately 40 sites globally. Participants will receive oral capsules or oral solution of cariprazine or placebo once daily for 8-weeks and will undergo a 4-week safety follow-up period. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Autism Spectrum Disorder
Autistic Disorder
Child Development Disorders, Pervasive

Clinical Trial Details

NCT number	NCT05439616
Study type	Interventional
Source	AbbVie
Contact	ABBVIE CALL CENTER
Phone	844-663-3742
Email	abbvieclinicaltrials@abbvie.com
Status	Recruiting
Phase	Phase 3
Start date	July 7, 2022
Completion date	November 25, 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05207956` - App for Strengthening Services In Specialized Therapeutic Support	N/A
Completed	`NCT03286621` - Development of Eye-tracking Based Markers for Autism in Young Children
Completed	`NCT02608333` - Efficiency of Early Intervention for Autism Spectrum Disorder	N/A
Recruiting	`NCT05935722` - Evaluation of a Home-based Parenting Support Program: Parenting Young Children	N/A
Active, not recruiting	`NCT06259539` - A YouTube Curriculum for Children With Autism and Obesity	N/A
Active, not recruiting	`NCT06303791` - Digital-based Psychosocial Intervention for Parents of Children With Neurodevelopmental Disorders	N/A
Enrolling by invitation	`NCT05017779` - A Hybrid Effectiveness-implementation Trial of a High School-based Executive Function Treatment for Autistic Youth	N/A
Completed	`NCT04772898` - Effectiveness of a 6-week Hippotherapy Program in Children With Autism Spectrum Disorder	N/A
Recruiting	`NCT04987541` - The Therapeutic Effect of TBS Stimulation on Emotion Regulation in Autism Spectrum Disorder	N/A
Completed	`NCT04308915` - Mobile-based Games for Cognitive Training in Children With Neurodevelopmental Disorders	N/A
Completed	`NCT06038435` - The Effect of Cognitive Orientation Approach on Daily Occupational Performance With Autism Spectrum Disorder	N/A
Terminated	`NCT04049981` - Investigation of Mechanisms of Action in Superpower Glass	Phase 1/Phase 2
Completed	`NCT03693313` - The Effect of CrossFit Kids on Social Skills in Children With Autism Spectrum Disorder (CrossFit KAMP)	N/A
Recruiting	`NCT04107064` - Achieving Steady Work Among Adults With Autism Through Specialized Employment Program	N/A
Recruiting	`NCT03812068` - Parent-mediated Developmental Behavioral Intervention	N/A
Completed	`NCT03206996` - Exposure Therapy for Auditory Sensitivity in Autism	N/A
Completed	`NCT02299700` - Study to Evaluate the Janssen Autism Knowledge Engine in Children and Adults With Autism Spectrum Disorder	N/A
Completed	`NCT03422016` - Electroretinogram in Autistic Spectrum Disorders
Active, not recruiting	`NCT03548779` - North Carolina Genomic Evaluation by Next-generation Exome Sequencing, 2	N/A
Recruiting	`NCT05114538` - Improving the Part C Early Intervention Service Delivery System for Children With ASD	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Study of Cariprazine Oral Capsules or Solution to Assess Adverse Events and Change in Irritability Due to Autism Spectrum Disorder (ASD) in Participants Aged 5-17 Years With ASD

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms