Clincosm LogoSign in Get a demo

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

Sponsor
AbbVie (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05439616
Collaborator
(none)
152
Enrollment
26
Locations
2
Arms
26.1
Anticipated Duration (Months)
5.8
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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 in the United States.

Participants will receive oral capsules or oral solution of cariprazine or placebo once daily for 8-weeks and will undergo a 12-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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
152 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jul 7, 2022
Anticipated Primary Completion Date :
May 24, 2024
Anticipated Study Completion Date :
Sep 8, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cariprazine

Participants will receive age-and weight dependent flexible doses of cariprazine once daily for 8-weeks.

Drug: Cariprazine
Oral Capsules or Oral Solution
Other Names:
  • VRAYLAR
  • AGN-241780

    		•
    Placebo Comparator: Placebo

    Participants will receive placebo once daily for 8-weeks.

    Drug: Placebo
    Oral capsules or Oral Solution

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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").

    2. 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.

    3. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 < 70).

    • History of any current psychiatric diagnosis other than ASD (including those with current intellectual development disability)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Advanced Research Center /ID# 245049 Anaheim California United States 92805
    2 Sun Valley Research Center /ID# 243133 Imperial California United States 92251-9401
    3 CHOC Children's Hospital /ID# 245577 Orange California United States 92868-4203
    4 Sarkis Clinical Trials /ID# 242868 Gainesville Florida United States 32607
    5 Advanced Research Institute of Miami /ID# 243179 Homestead Florida United States 33030-4613
    6 Sandhill Research LLC /ID# 245079 Lake Mary Florida United States 32746
    7 Axcess Medical Research /ID# 244952 Loxahatchee Groves Florida United States 33470
    8 Medical Research Group of Central Florida /ID# 243170 Orange City Florida United States 32763
    9 APG Research, LLC /ID# 243130 Orlando Florida United States 32803
    10 Nona Pediatric Center /ID# 245078 Orlando Florida United States 32829-8070
    11 Asclepes Research Centers - Spring Hill /ID# 248682 Spring Hill Florida United States 34609-5692
    12 Atlanta Center for Medical Research /ID# 243124 Atlanta Georgia United States 30331
    13 Atlanta Behavioral Research, LLC /ID# 243082 Dunwoody Georgia United States 30338
    14 Baber Research Group /ID# 242998 Naperville Illinois United States 60563-6502
    15 New Dawn Psychiatric Services PLLC /ID# 243697 Kinston North Carolina United States 28501-1603
    16 Cincinnati Children's Hospital /ID# 243968 Cincinnati Ohio United States 45229
    17 CincyScience /ID# 242993 West Chester Ohio United States 45069
    18 Relaro Medical Trials /ID# 243126 Dallas Texas United States 75243
    19 AIM Trials /ID# 243120 Plano Texas United States 75093
    20 Family Psychiatry of The Woodlands /ID# 242867 The Woodlands Texas United States 77381
    21 Advanced Research Institute - Ridgeline /ID# 243098 Ogden Utah United States 84405-6779
    22 Office of Maria Ona /ID# 248149 Franklin Virginia United States 23851
    23 Core Clinical Research /ID# 243084 Everett Washington United States 98201
    24 Multicare Institute for Research and Innovation /ID# 245153 Tacoma Washington United States 98405
    25 Dr. Samuel Sanchez PSC /ID# 245739 Caguas Puerto Rico 00727
    26 GCM Medical Group PSC /ID# 245735 San Juan Puerto Rico 00917-3104

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: ABBVIE INC., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT05439616
    Other Study ID Numbers:
    • M21-465
    First Posted:
    Jun 30, 2022
    Last Update Posted:
    Aug 24, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by AbbVie
    Autism Spectrum Disorder
    Cariprazine
    VRAYLAR
    AGN-241780
    Additional relevant MeSH terms:
    Disease
    Autistic Disorder
    Autism Spectrum Disorder
    Child Development Disorders, Pervasive
    Cariprazine

    Study Results

    No Results Posted as of Aug 24, 2022