Hialeah, Florida 33016

  • Bipolar I Disorder

Purpose:

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


Criteria:

Inclusion Criteria: - Participants with DSM-5 primary diagnosis of schizophrenia or bipolar I disorder as confirmed by K-SADS-PL for de novo participants. - Participant must have normal physical examination findings, clinical laboratory test results, and ECG results at Screening Visit 1, or from the last visit of respective lead-in study, or abnormal results that are determined to be not clinically significant by the investigator. - Negative serum β-hCG pregnancy test (all female participants). - Participants (if reached his spermarche or her menarche) and is sexually active, must agree to sexual abstinence or to use an approved birth control method for the full duration of participation in the study. The investigator and each participant will determine the appropriate method of contraception for the participant during their participation in the study. - Parent(s) or participant's legal representative(s) must be capable of giving signed Informed Consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol as explained by the investigator. Written informed consent from the Parent(s) or participant's legal representative(s) representative must be obtained prior to any study-related procedures. - Informed assent (unless local regulations require consent) must be obtained for all participants before eligibility evaluation for enrollment in the study. For 10-12-year-old participants, a different assent form will be used than that for rollover or de novo participants, 13-18- or 13-17-year-old participants, respectively. - Participant must have a caregiver (parent or legally authorized representative) who is willing and able to be responsible for safety monitoring of the participant, provide information about the participant's condition, oversee administration of study intervention, and accompany the participant to all study visits. - Participant must be able to swallow the study intervention. Exclusion Criteria: - Participants with DSM-5 diagnosis of schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, or psychotic disorder due to another medical condition - DSM-5 diagnosis of intellectual disability (IQ < 70). - Participant has a history of meeting DSM-5 diagnosis for any substance-related disorder (except caffeine- and tobacco-related) within the 3 months before Screening (Visit 1) of the respective lead-in study, and/or within the 3 months before Visit 1 of this OL study. - Participant with an acute or unstable medical condition, including (but not limited to) inadequately controlled diabetes, hepatic insufficiency (specifically any degree of jaundice), uncorrected hyper- or hypo-thyroidism, acute systemic infection, renal, gastrointestinal, respiratory, or cardiovascular disease. - Severe head trauma - History of seizures, with the exception of febrile seizures. - History of tumor of the central nervous system. - Participant requires concomitant treatment with strong CYP3A4 inhibitors or CYP3A4 inducers. If applicable, these drugs must be discontinued 7 days prior to Baseline (Visit 2). - Use of an antipsychotic depot within 2 cycles of their respective dosing interval prior to Screening (Visit 1). - Participant requires initiation or termination of psychotherapy within the 3 months preceding Screening (Visit 1), or plans to initiate, terminate, or change any outpatient psychotherapy during the course of the study. - ECT within 1 month of Screening (Visit 1). - Participant is unwilling to discontinue or, in the opinion of the investigator, unable to safely taper off any protocol-specified prohibited treatment prior to the Baseline (Visit 2) without significant destabilization or increased suicidality. - Participant is currently enrolled in another investigational drug or device study or participation in such a study within 3 months of Baseline (Visit 2) (with the exception of the 2 lead-in studies). - Known history of human immunodeficiency virus infection. - Female participant who entered menarche and is sexually active, and with any of the following at Screening (Visit 1): positive pregnancy test, nursing, or planning to become pregnant at any time during participation in the study - Known allergy or sensitivity to the study intervention or its components. - Participants from either lead-in study who become ineligible to participate - History of serious homicidal risk or behavior that resulted in hospitalization oradjudication (legal sentencing) within 6 months of Screening (Visit 1). - History of suicide attempt within 6 months of Screening (Visit 1) in the judgment of the investigator. - The participant has a condition or is in a situation, which, in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study. - Current suicidal or homicidal ideation in the judgment of the investigator.


Study is Available At:


Original ID:

3070-301-001


NCT ID:

NCT04578756


Secondary ID:


Study Acronym:


Brief Title:

Open-Label, Flexible-dose Study to Evaluate the Safety and Tolerability of Cariprazine in the Treatment of Pediatric Participants With Schizophrenia o


Official Title:

A 26-Week, Multicenter, Open-Label, Flexible-dose Study to Evaluate the Long-term Safety and Tolerability of Cariprazine in the Treatment of Pediatric Participants With Schizophrenia or Bipolar I Disorder


Overall Status:

Recruiting


Study Phase:

Phase 3


Genders:

N/A


Minimum Age:

10 Years


Maximum Age:

18 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Allergan


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

4


Number of Groups:

0


Total Enrollment:

200


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Paul Yeung
Study Director
Allergan
Primary Contact:Clinical Trials Registry Team
877-277-8566
IR-CTRegistration@Allergan.com

Study Dates

Start Date:February 1, 2021
Completion Date:May 10, 2023
Completion Type:Anticipated
Primary Completion Date:May 10, 2023
Primary Completion Type:Anticipated
Verification Date:May 2021
Last Changed Date:May 13, 2021
First Received Date:October 1, 2020

Study Outcomes

Outcome Type:Primary Outcome
Measure:Number of Participants With Treatment-emergent Adverse Events (TEAEs) in the Treatment Period
Time Frame:Baseline Day 1 to Week 30
Safety Issues:False
Description: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
Outcome Type:Primary Outcome
Measure:Number of Participants With Newly Emergent Adverse Events (NEAEs) in the Safety Follow-up Period
Time Frame:Baseline Day 1 to Week 30
Safety Issues:False
Description:An 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 unfavora
Outcome Type:Primary Outcome
Measure:Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters
Time Frame:Baseline Day 1 to Week 26
Safety Issues:False
Description:Clinical laboratory parameters included tests of hematology, chemistry, urinalysis and prolactin. The investigator assessed the results for clinical significance.
Outcome Type:Primary Outcome
Measure:Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Parameters
Time Frame:Baseline Day 1 to Week 30
Safety Issues:False
Description:Vital sign parameters included blood pressure, pulse rate, body mass index (BMI), weight, and waist circumference. The investigator assessed the results for clinical significance.
Outcome Type:Primary Outcome
Measure:Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECG)
Time Frame:Baseline Day 1 to Week 26
Safety Issues:False
Description:A standard 12-lead ECG was performed. The investigator determined the clinical significance of the ECG findings using the central ECG interpretation laboratory report.

Study Interventions

Intervention Type:Drug
Name:Cariprazine Flexible Dose
Description:1 capsule to be taken orally at approximately the same time of day (morning or evening)
Arm Name:Cariprazine Dose 1

Study Arms

Study Arm Type:Experimental
Arm Name:Cariprazine Dose 1
Description:Rollover and De Novo Participants with Schizophrenia 13 to 18 years (rollover) and 13 to17 years (de novo) Rollover and De Novo Participants with Bipolar I Disorder 10 to 12 years (weighing ≤40 kg), 10 to 12 years (weighing >40 kg), 13 to 18 years (rollover), and 13 to17 years (de novo)
Study Arm Type:Experimental
Arm Name:Cariprazine Dose 2
Description:Rollover and De Novo Participants with Schizophrenia 13 to 18 years (rollover) and 13 to17 years (de novo) Rollover and De Novo Participants with Bipolar I Disorder 10 to 12 years (weighing ≤40 kg), 10 to 12 years (weighing >40 kg), 13 to 18 years (rollover), and 13 to17 years (de novo)
Study Arm Type:Experimental
Arm Name:Cariprazine Dose 3
Description:Rollover and De Novo Participants with Schizophrenia 13 to 18 years (rollover) and 13 to17 years (de novo) Rollover and De Novo Participants with Bipolar I Disorder 10 to 12 years (weighing ≤40 kg), 10 to 12 years (weighing >40 kg), 13 to 18 years (rollover), and 13 to17 years (de novo)
Study Arm Type:Experimental
Arm Name:Cariprazine Dose 4
Description:Rollover and De Novo Participants with Schizophrenia 13 to 18 years (rollover) and 13 to17 years (de novo) Rollover and De Novo Participants with Bipolar I Disorder 13 to 18 years (rollover), and 13 to17 years (de novo)

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Allergan

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: September 23, 2021

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