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

Autism Spectrum Disorder Clinical Trial

Official title:

An 8-Week, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Phase 3 Study of the Efficacy and Safety of Cariprazine in the Treatment of Pediatric Subjects (5 to 17 Years of Age) With Autism Spectrum Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05439616
• Other study ID #: M21-465
• Status: Recruiting
• Phase: Phase 3
• Start date: July 7, 2022
• Est. completion date: November 25, 2024

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 152
• Est. completion date: November 25, 2024
• Est. primary completion date: October 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

Inclusion Criteria:

• Participants at the time of screening must have a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of ASD, confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime (K-SADS-PL) administered at screening (Visit 1) by a trained clinician.

• Participants must have an Aberrant Behavior Checklist, 2nd edition - Community Version
• Irritability (ABC-I) subscale score = 18 (Visits 1 and 2).

• Participants must have a Clinical Global Impressions - Severity - Irritability (CGI-S Irritability) score = 4 at screening (Visits 1 and 2).

Exclusion Criteria:

• Participants with diagnosis of intellectual disability (Intelligence quotient < 25).

• No history of major depressive disorder, bipolar disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, or psychotic disorder due to another medical condition, as excluded by administration of Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime (K-SADS-PL).

• History of ASD that is associated with Rett Disorder, Fragile-X Syndrome, or Childhood Disintegrative Disorder.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Drug:
• Cariprazine
Oral Capsules or Oral Solution
• Placebo
Oral capsules or Oral Solution

Locations

Country	Name	City	State
Puerto Rico	Dr. Samuel Sanchez PSC /ID# 245739	Caguas
Puerto Rico	GCM Medical Group PSC /ID# 245735	San Juan
United States	Advanced Research Center /ID# 245049	Anaheim	California
United States	Atlanta Center for Medical Research /ID# 243124	Atlanta	Georgia
United States	BioBehavioral Research of Austin /ID# 255460	Austin	Texas
United States	Quest Therapeutics of Avon Lake /ID# 252013	Avon Lake	Ohio
United States	Northwest Clinical Research Center /ID# 243083	Bellevue	Washington
United States	Cincinnati Children's Hospital /ID# 243968	Cincinnati	Ohio
United States	Cedar Health Research /ID# 248683	Dallas	Texas
United States	Relaro Medical Trials /ID# 243126	Dallas	Texas
United States	D&H Doral Research Center-Doral /ID# 255457	Doral	Florida
United States	Atlanta Behavioral Research, LLC /ID# 243082	Dunwoody	Georgia
United States	Core Clinical Research /ID# 243084	Everett	Washington
United States	Sarkis Clinical Trials /ID# 242868	Gainesville	Florida
United States	Advanced Research Institute of Miami /ID# 243179	Homestead	Florida
United States	Sun Valley Research Center /ID# 243133	Imperial	California
United States	Dr. Hosneara, M.D. LLC /ID# 252129	Jackson Heights	New York
United States	New Dawn Psychiatric Services PLLC /ID# 243697	Kinston	North Carolina
United States	Sandhill Research LLC /ID# 245079	Lake Mary	Florida
United States	Alivation Research /ID# 242915	Lincoln	Nebraska
United States	Axcess Medical Research /ID# 244952	Loxahatchee Groves	Florida
United States	G+C Research Group, LLC /ID# 252016	Miami	Florida
United States	Advanced Research Institute /ID# 243098	Ogden	Utah
United States	CHOC Children's Hospital /ID# 245577	Orange	California
United States	Medical Research Group of Central Florida /ID# 243170	Orange City	Florida
United States	APG Research, LLC /ID# 243130	Orlando	Florida
United States	K2 Medical Research - Orlando - South Orlando Avenue /ID# 248694	Orlando	Florida
United States	Nona Pediatric Center /ID# 245078	Orlando	Florida
United States	AIM Trials /ID# 243120	Plano	Texas
United States	iResearch Savannah /ID# 254582	Savannah	Georgia
United States	Asclepes Research Centers - Spring Hill /ID# 248682	Spring Hill	Florida
United States	Richmond Behavioral Associates An Evolution Research Group Portfolio Company /ID# 259578	Staten Island	New York
United States	D&H Tamarac Research Center /ID# 250436	Tamarac	Florida
United States	Family Psychiatry of The Woodlands /ID# 242867	The Woodlands	Texas
United States	Pacific Clinical Research Management Group /ID# 243019	Upland	California
United States	CincyScience /ID# 242993	West Chester	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Aberrant Behavior Checklist, 2nd edition - Community Version - Irritability (ABC-I) Subscale Score	The Aberrant Behavior Checklist (ABC) - Community version is a 58-item, caregiver-rated scale designed to measure inappropriate and maladaptive behavior of people with developmental disabilities (including intellectual disability and ASD). The ABC has 5 subscales (Irritability, Social Withdrawal, Stereotypic Behavior, Hyperactivity and Inappropriate Speech). The caregiver rates the child's behavior from 0=not at all a problem to 3= the problem is severe in degree. The range for Irritability is 0 to 45. Higher scores indicate greater severity.	Baseline (Week 0) to Week 8
Secondary	Percentage of Participants with responder status of "Very Much Improved" or "Much Improved" on the Clinical Global Impression- Change Irritability (CGI-C Irritability) Scale	The Clinical Global Impression - Change-Irritability (CGI-C Irritability) is a single-item rating scale that assesses change in the severity of a participant's irritability from the clinician's perspective. The CGI-C Irritability 7-point graded response scale (1 = "Very much improved," 2 = "Much improved," 3 = "Minimally improved," 4 = "No change," 5 = "Minimally worse," 6 = "Much worse," or 7 = "Very much worse").	Week 8
Secondary	Change from Baseline in Parent-Rated Anxiety Scale for Youth with Autism Spectrum Disorder (PRAS-ASD) Total Score	PRAS-ASD is a 25-item caregiver-reported measure of anxiety in participants aged 3 to 17 with ASD. All items use a 4-point response scale: 0 = "None (not present);" 1 = "Mild (present sometimes, not a real problem);" 2 = "Moderate (often present and a problem);" 3 = "Severe (very frequent and a major problem)." Total score ranges from 0 to 75, with higher scores indicating greater severity of anxiety.	Baseline (Week 0) to Week 8
Secondary	Change from Baseline in Caregiver Strain Questionnaire Short Form 7-Item (CGSQ SF-7) total score	CGSQ SF-7 is a caregiver-reported 7-item measure of self-reported strain that focuses on the impact of caring for a child with emotional and behavioral problems. Responses are scored on a 5-point scale (1 = "Not at all," 2 = "A little;" 3 = "Somewhat;" 4 = "Quite a bit;" and 5 "Very much") with higher scores indicating greater caregiver strain.	Baseline (Week 0) to Week 8

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