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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 (10-17 years) | Experimental | 10 to 12 years: 0.75 mg/day cariprazine oral solution 13 to 17 years: 1.5 mg/day cariprazine oral solution |
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| Cohort 2 (10-17 years) | Experimental | 10 to 12 years: 1.5 mg/day cariprazine oral solution 13 to 17 years: 3.0 mg/day cariprazine oral solution |
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| Cohort 3 (5-9 years) | Experimental | 0.5 mg/day cariprazine oral solution |
|
| Cohort 4 (5-9 years) | Experimental | 1.5 mg/day cariprazine oral solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cariprazine | Drug | Oral Solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) | Up to 30 days after last visit or last dose for participants who discontinue early | |
| Incidence of Serious Adverse Events (SAEs) | Up to 30 days after last visit or last dose for participants who discontinue early | |
| Incidence of AEs leading to discontinuation | Up to 30 days after last visit or last dose for participants who discontinue early | |
| Percentage of participants with potentially clinically significant values in clinical laboratory assessments | Up to 84 days | |
| Percentage of participants with potentially clinically significant values in vital signs assessments | Up to 84 days | |
| Percentage of participants with potentially clinically significant values in ECG assessments | Up to 84 Days | |
| Percentage of participants who have suicidal ideation or suicidal behaviors in C-SSRS assessments | Up to 84 Days | |
| Percentage of participants with treatment-emergent parkinsonism in SAS assessments | Up to 84 Days | |
| Percentage of participants with treatment-emergent akathisia in BARS assessments | Up to 84 days | |
| Percentage of participants with potentially clinically significant values in ocular examination parameters |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ALLERGAN INC. | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuropsychiatric Research Center of Orange County /ID# 233663 | Orange | California | 92868 | United States | ||
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| Label | URL |
|---|---|
| Additional information on study locations near you may be found at AllerganClinicalTrials.com. | View source |
| To be considered as a site for current and future Allergan Clinical Trials, please register using the Investigator Databank link. | View source |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C533287 | cariprazine |
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| Screening to Day 84 |
| Pharmacokinetics: Maximum plasma concentrations (Cmax) of cariprazine and its metabolites DCAR and DDCAR on Days 1 and 42 | Day 1 and Day 42 |
| Pharmacokinetics: Time of maximum plasma concentrations (Tmax) of cariprazine and its metabolites DCAR and DDCAR on Days 1 and 42 | Day 1 and Day 42 |
| Pharmacokinetics: Area under the plasma concentration-time curve during the dosing interval (AUC0-tau) of cariprazine and its metabolites DCAR and DDCAR on Days 1 and 42 | Day 1 and Day 42 |
| Pharmacokinetics: Terminal elimination half-life (T1/2) of cariprazine and its metabolites DCAR and DDCAR | Day 42 to Day 84 |
| Pharmacokinetics: Minimum plasma concentrations (Cmin) during the dosing interval of cariprazine and its metabolites DCAR and DDCAR on Day 42 | Day 42 |
| Pharmacokinetics: Average plasma concentrations (Cavg) during the dosing interval of cariprazine and its metabolites DCAR and DDCAR on Day 42 | Day 42 |
| Pharmacokinetics: Apparent total clearance of cariprazine from plasma (CL/F) on Day 42 | Day 42 |
| Pharmacokinetics: Volume of distribution during the terminal elimination phase (Vz/F) of cariprazine | Day 42 to Day 84 |
| Atlanta Center for Medical Research /ID# 233576 |
| Atlanta |
| Georgia |
| 30331 |
| United States |
| iResearch Atlanta, LLC /ID# 233614 | Decatur | Georgia | 30030 | United States |