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
- Registration Number
- NCT05439616
- Lead Sponsor
- AbbVie
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 161
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants will receive placebo once daily for 8-weeks. Cariprazine Cariprazine Participants will receive age-and weight dependent flexible doses of cariprazine once daily for 8-weeks.
- Primary Outcome Measures
Name Time Method Change from Baseline in Aberrant Behavior Checklist, 2nd edition - Community Version - Irritability (ABC-I) Subscale Score Baseline (Week 0) to Week 8 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants with responder status of "Very Much Improved" or "Much Improved" on the Clinical Global Impression- Change Irritability (CGI-C Irritability) Scale Week 8 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").
Change from Baseline in Parent-Rated Anxiety Scale for Youth with Autism Spectrum Disorder (PRAS-ASD) Total Score Baseline (Week 0) to Week 8 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.
Change from Baseline in Caregiver Strain Questionnaire Short Form 7-Item (CGSQ SF-7) total score Baseline (Week 0) to Week 8 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.
Trial Locations
- Locations (36)
Cincinnati Children's Hospital /ID# 243968
🇺🇸Cincinnati, Ohio, United States
Core Clinical Research /ID# 243084
🇺🇸Everett, Washington, United States
Family Psychiatry of The Woodlands /ID# 242867
🇺🇸The Woodlands, Texas, United States
Richmond Behavioral Associates An Evolution Research Group Portfolio Company /ID# 259578
🇺🇸Staten Island, New York, United States
Atlanta Center for Medical Research /ID# 243124
🇺🇸Atlanta, Georgia, United States
New Dawn Psychiatric Services PLLC /ID# 243697
🇺🇸Kinston, North Carolina, United States
CincyScience /ID# 242993
🇺🇸West Chester, Ohio, United States
GCM Medical Group PSC /ID# 245735
🇵🇷San Juan, Puerto Rico
AIM Trials /ID# 243120
🇺🇸Plano, Texas, United States
Advanced Research Institute of Miami /ID# 243179
🇺🇸Homestead, Florida, United States
G+C Research Group, LLC /ID# 252016
🇺🇸Miami, Florida, United States
Medical Research Group of Central Florida /ID# 243170
🇺🇸Orange City, Florida, United States
Sandhill Research LLC /ID# 245079
🇺🇸Lake Mary, Florida, United States
Asclepes Research Centers - Spring Hill /ID# 248682
🇺🇸Spring Hill, Florida, United States
Pacific Clinical Research Management Group /ID# 243019
🇺🇸Upland, California, United States
Advanced Research Center /ID# 245049
🇺🇸Anaheim, California, United States
CHOC Children's Hospital /ID# 245577
🇺🇸Orange, California, United States
Sun Valley Research Center /ID# 243133
🇺🇸Imperial, California, United States
D&H Doral Research Center-Doral /ID# 255457
🇺🇸Doral, Florida, United States
Axcess Medical Research /ID# 244952
🇺🇸Loxahatchee Groves, Florida, United States
D&H Tamarac Research Center /ID# 250436
🇺🇸Tamarac, Florida, United States
Atlanta Behavioral Research, LLC /ID# 243082
🇺🇸Dunwoody, Georgia, United States
iResearch Savannah /ID# 254582
🇺🇸Savannah, Georgia, United States
Quest Therapeutics of Avon Lake /ID# 252013
🇺🇸Avon Lake, Ohio, United States
Relaro Medical Trials /ID# 243126
🇺🇸Dallas, Texas, United States
Cedar Health Research /ID# 248683
🇺🇸Dallas, Texas, United States
Dr. Samuel Sanchez PSC /ID# 245739
🇵🇷Caguas, Puerto Rico
Northwest Clinical Research Center /ID# 243083
🇺🇸Bellevue, Washington, United States
Advanced Research Institute /ID# 243098
🇺🇸Ogden, Utah, United States
Alivation Research /ID# 242915
🇺🇸Lincoln, Nebraska, United States
Dr. Hosneara, M.D. LLC /ID# 252129
🇺🇸Jackson Heights, New York, United States
K2 Medical Research - Orlando - South Orlando Avenue /ID# 248694
🇺🇸Orlando, Florida, United States
APG Research, LLC /ID# 243130
🇺🇸Orlando, Florida, United States
Nona Pediatric Center /ID# 245078
🇺🇸Orlando, Florida, United States
Sarkis Clinical Trials /ID# 242868
🇺🇸Gainesville, Florida, United States
BioBehavioral Research of Austin /ID# 255460
🇺🇸Austin, Texas, United States