NCT04578756|CompletedPhase 3FDA Drug

Open-Label, Flexible-dose Study to Evaluate the Long-Term Safety and Tolerability of Cariprazine in the Treatment of Pediatric Participants With Schizophrenia, Bipolar I Disorder, or Autism Spectrum Disorder

3070 Ped OLE

A 52-Week, Multicenter, Open-Label, Flexible-dose Study to Evaluate the Long-term Safety and Tolerability of Cariprazine in the Treatment of Pediatric Subjects With Schizophrenia, Bipolar I Disorder, or Autism Spectrum Disorder

AbbVie ClinicalTrials.gov

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1 other identifier

3070-301-001

Study Type

interventional

Target

310

Locations

2 countries

Sites

Timeline

RegisteredOct 2020

StartedFeb 2021

CompletionOct 2025

Brief Summary

The purpose of this study is to evaluate the long-term safety and tolerability of cariprazine in the treatment of pediatric participants with schizophrenia, bipolar I disorder, or autism spectrum disorder (ASD) and to establish the benefit-risk profile of long-term treatment in this population.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

310

participants targeted

Target at P50-P75 for phase_3 schizophrenia

Timeline

Completed

Started Feb 2021

Longer than P75 for phase_3 schizophrenia

Geographic Reach

2 countries

42 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.7 years study duration

First Submitted

Initial submission to the registry

October 1, 2020

Completed

7 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed

4 months until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed

4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2025

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2025

Completed

Last Updated

October 27, 2025

Status Verified

October 1, 2025

Enrollment Period

4.7 years

First QC Date

October 1, 2020

Last Update Submit

October 23, 2025

Conditions

Schizophrenia Bipolar I Disorder Autism Spectrum Disorder (ASD)

Keywords

SchizophreniaBipolar I DisorderCariprazineAutism Spectrum Disorder (ASD)

Outcome Measures

Primary Outcomes (9)

Number of Participants With Treatment-emergent Adverse Events (TEAEs) in the Treatment Period
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (i.e. laboratory value), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. A TEAE is an AE that occurs or worsens after receiving study drug.
Baseline Day 1 to Week 59
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters
Clinical laboratory parameters included tests of hematology, chemistry, urinalysis and prolactin. The investigator assessed the results for clinical significance.
Baseline Day 1 to Week 52
Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Parameters
Vital sign parameters included blood pressure, pulse rate, body mass index (BMI), weight, and waist circumference. The investigator assessed the results for clinical significance.
Baseline Day 1 to Week 59
Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECG)
A standard 12-lead ECG was performed. The investigator determined the clinical significance of the ECG findings using the central ECG interpretation laboratory report.
Baseline Day 1 to Week 52
Number of Participants With Suicidal Ideation or Suicidal Behavior as Recorded on the Columbia-Suicide Severity Rating (C-SSRS) Scale
C-SSRS is a clinician-rated scale that reports the severity of both suicidal ideation and behavior. Suicidal ideation is classified on a 5-item scale: 1 "wish to be dead," and 5 "active suicidal ideation with specific plan and intent". Suicidal behavior is classified on a 5-item scale: 0 "no suicidal behavior, and 4 "actual attempt".
Baseline Day 1 to Week 52
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)
AIMS assesses abnormal involuntary movements, such as tardive dyskinesia, associated with antipsychotic drugs; it measures facial, oral, extremities, and trunk movements, as well as the participant's awareness of abnormal movements. The first 10 items are rated on a none (0) to severe (4) scale. There are an additional 2 items on dental status that are answered yes or no.
Baseline Day 1 to Week 52
Change From Baseline in Barnes Akathisia Rating Scale (BARS)
BARS is a 4-item rating scale used to assess drug-induced akathisia. The scale comprises items for rating the observable restless movements that characterize the condition, the subjective awareness of restlessness, and any distress associated with the akathisia (each on a 4-point scale from normal \[0\] to severe \[3\]). In addition, there is a global severity for akathisia rated on a 6-point scale (absent \[0\] to severe akathisia \[5\]).
Baseline Day 1 to Week 52
Change From Baseline in Simpson-Angus Scale (SAS)
SAS is a 10-item rating scale for assessment of antipsychotic-induced parkinsonism in both clinical practice and research settings. Each item ranges from 0 (normal) to 4 (extreme symptoms). The scale consists of 1 item measuring gait (hypokinesia), 6 items measuring rigidity, and 3 items measuring glabella tap, tremor, and salivation, respectively.
Baseline Day 1 to Week 52
Number of Participants With Clinically Significant Changes From Baseline in Opthalmologic Parameters
Ocular examination parameters included Intraocular pressure (IOP) measurement, Best-corrected visual acuity (BCVA), color fundus photography, color vision testing using Hardy Rand and Rittler (HRR) plates, and assessment of Optical coherence tomography (OCT) and cataracts. The investigator assessed the results for clinical significance.
Baseline Day 1 to Week 52

Study Arms (11)

Cariprazine Dose 1

EXPERIMENTAL

Participants with Schizophrenia (age 13 to 17 years and \< 40 kg body weight) will receive cariprazine.