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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06229210
Other study ID # ITI-007-321
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date January 25, 2024
Est. completion date December 2027

Study information

Verified date January 2024
Source Intra-Cellular Therapies, Inc.
Contact ITI Clinical Trials
Phone 646 440-9333
Email ITCIClinicalTrials@itci-inc.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a multicenter, global, 26-week, open-label study to assess the safety and tolerability of lumateperone in pediatric patients with schizophrenia or bipolar disorder.


Description:

The study will enroll pediatric patients as follows: De Novo Patients: - Patients with schizophrenia, including patients who have previously participated in the lumateperone open-label pediatric pharmacokinetic (PK) study (Study ITI-007-020) - Patients with bipolar disorder who have previously participated in the lumateperone open-label pediatric PK study (Study ITI-007-030) Rollover Patients: • Patients with bipolar disorder who are enrolling directly from a lead-in efficacy study. This study will be conducted as follows: - A Screening Period of up to 2 weeks during which patient eligibility will be assessed. - A 26-week Open-label Treatment Period (OLTP) during which all patients will receive open-label lumateperone once daily. - A 2-week Safety Follow-up (SFU) Period: All patients should return to the clinic for the SFU visit approximately 2 weeks after the last dose of open-label lumateperone.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date December 2027
Est. primary completion date December 2027
Accepts healthy volunteers No
Gender All
Age group 10 Years to 17 Years
Eligibility Inclusion Criteria: De Novo Patients must meet the following criteria: - Able to provide consent as follows: - The patient's legally authorized representative (LAR) (eg, parent or guardian) must provide written, informed consent; - The patient must provide written assent to study enrollment; - Male or female patients aged 13 to 17 years (inclusive) with schizophrenia or male or female patients aged 10 to 17 years (inclusive) with bipolar I or II disorder; - Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of schizophrenia or bipolar I or II disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL). - Is currently an outpatient and is anticipated to maintain outpatient status for the duration of the study. Rollover Patients entering from the lead-in study must meet all of the following criteria: - Must have safely completed the lead-in study, in the opinion of the Investigator - Able to provide consent as follows: - The patient's LAR must provide written, informed consent; - The patient must provide written assent to study enrollment Exclusion Criteria: De Novo Patients who meet any of the following exclusion criteria will not be eligible to participate in this study: - Has a primary psychiatric diagnosis other than schizophrenia or bipolar I or bipolar II disorder. Schizophrenia with catatonia, or bipolar disorder with psychotic features are not allowed. Exceptions include: - ADHD: If a subject is taking psychostimulant(s) for ADHD, they must have been on a stable treatment regimen of these medication(s) for 30 days prior to Screening. The treatment regimen should remain stable throughout the study. This must be confirmed by the Investigator and noted in the source records. - Mild intellectual disability based on Investigator opinion and DSM-5 criteria (Moderate and Severe intellectual disability are excluded. - In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during their participation in the study or - At Screening, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 of the Columbia-Suicide Severity Rating Scale (C SSRS) within 6 months prior to Screening or, at Baseline, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 since the Screening Visit; - At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or - At Screening or Baseline, scores > 3 on Item 13 (suicidal ideation) of the CDRS-R (for bipolar disorder patients only); or - The patient is considered to be an imminent danger to him/herself or others. Because all Rollover Patients were required to not meet any exclusion criteria for participation in the lead-in study, the Investigator should assess if there has been any change in patient health status. Any newly-emergent medical condition reported during the lead-in study must be evaluated by the Investigator and should be discussed with the Sponsor or designee before enrolling the patient in this study. Rollover Patients will directly enroll from the lead-in efficacy study at Day 1 of this long-term safety study. Rollover Patients who meet any of the following exclusion criteria will not be eligible to participate in this study: - The patient is unable to comply with study procedures or judged to be inappropriate for the study, in the opinion of the Investigator - The patient has a significant risk for suicidal behavior during the course of her/his participation in the study or is considered to be an imminent danger to her/himself or others, in the opinion of the Investigator, and/or: - At the Baseline Visit the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 of the C-SSRS using the "Since the Last Visit" version (used at Visit 8/Week 6 of the lead in study); - At the Baseline Visit, scores > 3 on Item 13 (suicidal ideation) of the CDRS-R (based on the Visit 8/Week 6 assessment from the lead in study); or - The patient is considered to be an imminent danger to him/herself or others. - The patient had any abnormal clinical laboratory tests results during the lead-in study that were considered clinically significant and preclude safe participation in this study, based on the Investigator's clinical judgement.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Lumateperone
Lumateperone 42 mg capsules administered orally, once daily

Locations

Country Name City State
United States Clinical Site Anaheim California
United States Clinical Site Atlanta Georgia
United States Clinical Site Cincinnati Ohio
United States Clinical Site Colton California
United States Clinical Site Decatur Georgia
United States Clinical Site Indianapolis Indiana
United States Clinical Site Lawrenceville Georgia
United States Clinical Site Long Beach California
United States Clinical Site Miami Florida
United States Clinical Site Miami Springs Florida
United States Clinical Site Oklahoma City Oklahoma
United States Clinical Site Orlando Florida
United States Clinical Site San Diego California

Sponsors (1)

Lead Sponsor Collaborator
Intra-Cellular Therapies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Common Adverse Events An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Up to 6 months
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