Status:
RECRUITING
Safety, Tolerability and Pharmacokinetics of Lumateperone in Pediatric Patients With Autism Spectrum Disorder
Lead Sponsor:
Intra-Cellular Therapies, Inc.
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
5-12 years
Phase:
PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT06557902
Start Date
May 10 2024
End Date
July 31 2026
Last Update
August 16 2024
Active Locations (8)
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1
Clinical Site 6
Miami, Florida, United States, 33133
2
Clinical Site 7
Orlando, Florida, United States, 32803
3
Clinical Site 1
Atlanta, Georgia, United States, 30331
4
Clinical Site 2
Decatur, Georgia, United States, 30030