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
NCT ID: NCT05439616
Last Updated: 2025-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
161 participants
INTERVENTIONAL
2022-07-07
2024-10-04
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cariprazine
Participants will receive age-and weight dependent flexible doses of cariprazine once daily for 8-weeks.
Cariprazine
Oral Capsules or Oral Solution
Placebo
Participants will receive placebo once daily for 8-weeks.
Placebo
Oral capsules or Oral Solution
Interventions
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Cariprazine
Oral Capsules or Oral Solution
Placebo
Oral capsules or Oral Solution
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
5 Years
17 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Advanced Research Center /ID# 245049
Anaheim, California, United States
Sun Valley Research Center /ID# 243133
Imperial, California, United States
CHOC Children's Hospital /ID# 245577
Orange, California, United States
Pacific Clinical Research Management Group /ID# 243019
Upland, California, United States
D&H Doral Research Center-Doral /ID# 255457
Doral, Florida, United States
Sarkis Clinical Trials /ID# 242868
Gainesville, Florida, United States
Advanced Research Institute of Miami /ID# 243179
Homestead, Florida, United States
Sandhill Research LLC /ID# 245079
Lake Mary, Florida, United States
Axcess Medical Research /ID# 244952
Loxahatchee Groves, 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
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
Asclepes Research Centers - Spring Hill /ID# 248682
Spring Hill, Florida, United States
D&H Tamarac Research Center /ID# 250436
Tamarac, Florida, United States
Atlanta Center for Medical Research /ID# 243124
Atlanta, Georgia, United States
Atlanta Behavioral Research, LLC /ID# 243082
Dunwoody, Georgia, United States
iResearch Savannah /ID# 254582
Savannah, Georgia, United States
Alivation Research /ID# 242915
Lincoln, Nebraska, United States
Dr. Hosneara, M.D. LLC /ID# 252129
Jackson Heights, New York, United States
Richmond Behavioral Associates An Evolution Research Group Portfolio Company /ID# 259578
Staten Island, New York, United States
New Dawn Psychiatric Services PLLC /ID# 243697
Kinston, North Carolina, United States
Quest Therapeutics of Avon Lake /ID# 252013
Avon Lake, Ohio, United States
Cincinnati Children's Hospital /ID# 243968
Cincinnati, Ohio, United States
CincyScience /ID# 242993
West Chester, Ohio, United States
BioBehavioral Research of Austin /ID# 255460
Austin, Texas, United States
Relaro Medical Trials /ID# 243126
Dallas, Texas, United States
Cedar Health Research /ID# 248683
Dallas, Texas, United States
AIM Trials /ID# 243120
Plano, Texas, United States
Family Psychiatry of The Woodlands /ID# 242867
The Woodlands, Texas, United States
Advanced Research Institute /ID# 243098
Ogden, Utah, United States
Northwest Clinical Research Center /ID# 243083
Bellevue, Washington, United States
Core Clinical Research /ID# 243084
Everett, Washington, United States
Dr. Samuel Sanchez PSC /ID# 245739
Caguas, , Puerto Rico
GCM Medical Group PSC /ID# 245735
San Juan, , Puerto Rico
Countries
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Related Links
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Other Identifiers
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M21-465
Identifier Type: -
Identifier Source: org_study_id
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