Actively Recruiting
Safety, Tolerability and Pharmacokinetics of Lumateperone in Pediatric Patients With Autism Spectrum Disorder
Led by Intra-Cellular Therapies, Inc. · Updated on 2024-08-16
26
Participants Needed
8
Research Sites
116 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety, Tolerability and Pharmacokinetics of Lumateperone in Pediatric Patients With Autism Spectrum Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 6512 at Screening
- CGI-S score of 6513 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
You will not qualify if you...
- 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 the patient to be a safety risk to him/herself or others
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Clinical Site 6
Miami, Florida, United States, 33133
Not Yet Recruiting
2
Clinical Site 7
Orlando, Florida, United States, 32803
Not Yet Recruiting
3
Clinical Site 1
Atlanta, Georgia, United States, 30331
Actively Recruiting
4
Clinical Site 2
Decatur, Georgia, United States, 30030
Actively Recruiting
5
Clinical Site 3
Savannah, Georgia, United States, 31405
Actively Recruiting
6
Clinical Site 4
Saint Charles, Missouri, United States, 63304
Actively Recruiting
7
Clinical Site 5
Lincoln, Nebraska, United States, 68526
Actively Recruiting
8
Clinical Site 8
Everett, Washington, United States, 98201
Actively Recruiting
Research Team
I
ITI Clinical Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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