Cariprazine Pediatric ASD PK Study

Part of paid clinical trials in Orange, California.

Sponsor
AbbVie
Study ID
NCT04382885
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
5 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This study will be a multi-center, open-label, parallel-group, multiple-dose study in up to 24 male and female participants aged 5 through 17 years, inclusive, with Autism Spectrum Disorder (ASD). The 24 participants will be enrolled into 1 of 4 cohorts (6 participants per cohort).

Key Dates

Start date
Jun 26, 2020
Status verified
Apr 2022
Primary completion
Dec 10, 2021
Completion
Dec 10, 2021

Study Design

Enrollment
24 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 (10-17 years)
    10 to 12 years: 0.75 mg/day cariprazine oral solution 13 to 17 years: 1.5 mg/day cariprazine oral solution
  • Experimental: Cohort 2 (10-17 years)
    10 to 12 years: 1.5 mg/day cariprazine oral solution 13 to 17 years: 3.0 mg/day cariprazine oral solution
  • Experimental: Cohort 3 (5-9 years)
    0.5 mg/day cariprazine oral solution
  • Experimental: Cohort 4 (5-9 years)
    1.5 mg/day cariprazine oral solution

Primary Outcome Measure

Incidence of Adverse Events (AEs) [ Time Frame: Up to 30 days after last visit or last dose for participants who discontinue early ]

Locations (3)

FacilityCityStateZIPSite coordinators
Neuropsychiatric Research Center of Orange County /ID# 233663OrangeCalifornia92868-
Atlanta Center for Medical Research /ID# 233576AtlantaGeorgia30331-
iResearch Atlanta, LLC /ID# 233614DecaturGeorgia30030-

Find similar trials in Orange, CA

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
Neuropsychiatric Research Center of Orange County· Orange, CAAtlanta Center for Medical Research· Atlanta, GAiResearch Atlanta, LLC· Decatur, GA

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