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Tests treatment safety and results for Autism Spectrum Disorder
Official title Safety, Tolerability and Pharmacokinetics of Lumateperone in Pediatric Patients With Autism Spectrum Disorder
ClinicalTrials.gov ID: NCT06557902
What this study is testing
What is Lumateperone 10.5 mg capsule?
Lumateperone 10.5 mg capsule is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for autism spectrum disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Study ITI-007-035 is a Phase 1b, multicenter, open-label study to evaluate the safety, tolerability, and PK of lumateperone for pediatric patients with Autism Spectrum Disorder.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 12
You may be able to join if
- Male or female patients between 5 to less than 13 years of age
- Primary clinical diagnosis of ASD with symptoms of irritability
- ABC-I subscale score of ≥12 at Screening
- CGI-S score of ≥3 at Screening
- Body mass index (BMI) greater than the 5th percentile according to age- and gender-specific CDC Clinical Growth Charts (2000) at Screening
You likely can't join if
- Has a primary psychiatric diagnosis other than ASD
- Reports suicidal ideation (Type 3, 4 or 5 on the Baseline/Screening version of the C-SSRS) within 6 months prior to Screening, or any suicidal...
- Clinically significant abnormality within 2 years of Screening that in the Investigator's opinion may place the patient at risk or interfere with...
- History of a clinically significant cardiac disorder and/or abnormal screening ECG or a QT interval corrected for heart rate using Fridericia formula...
- Patients with a history of orthostatic hypotension or who have orthostatic hypotension at Screening
- Has a history of uncontrolled/disruptive behavior in the past 30 days that, in the Investigator's opinion, would preclude the ability to participate...
See the full eligibility criteria
- Male or female patients between 5 to less than 13 years of age
- Primary clinical diagnosis of ASD with symptoms of irritability
- ABC-I subscale score of ≥12 at Screening
- CGI-S score of ≥3 at Screening
- Body mass index (BMI) greater than the 5th percentile according to age- and gender-specific CDC Clinical Growth Charts (2000) at Screening
- Ability to swallow capsules
- Has a primary psychiatric diagnosis other than ASD
- Reports suicidal ideation (Type 3, 4 or 5 on the Baseline/Screening version of the C-SSRS) within 6 months prior to Screening, or any suicidal behavior within 2 years prior to Screening, and/or the Investigator assesses...
- Clinically significant abnormality within 2 years of Screening that in the Investigator's opinion may place the patient at risk or interfere with study outcome variables
- History of a clinically significant cardiac disorder and/or abnormal screening ECG or a QT interval corrected for heart rate using Fridericia formula (QTcF) \> 460 msec at Screening
- Patients with a history of orthostatic hypotension or who have orthostatic hypotension at Screening
- Has a history of uncontrolled/disruptive behavior in the past 30 days that, in the Investigator's opinion, would preclude the ability to participate in study procedures
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
- Orlando, Florida, United States
- Atlanta, Georgia, United States
- Decatur, Georgia, United States
- Savannah, Georgia, United States
- Saint Charles, Missouri, United States
- Lincoln, Nebraska, United States
- Everett, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 years to 12 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States; Orlando, Florida, United States; Atlanta, Georgia, United States; Decatur, Georgia, United States; Savannah, Georgia, United States; Saint Charles, Missouri, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.