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New treatment option for Irritability Associated With Autism Spectrum Disorder
Official title Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients
ClinicalTrials.gov ID: NCT06690398
What this study is testing
What is Lumateperone high dose?
Lumateperone high dose is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for irritability associated with 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
- This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients aged 5 to 17 years with a primary diagnosis of irritability associated with Autism Spectrum Disorder (ASD) based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) and confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia Present and Lifetime Version (K-SADS-PL).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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 17
You may be able to join if
- All patients must have a legally authorized representative LAR (eg, parent or legal guardian) who is willing and able to be responsible for the...
- Able to provide consent as follows:
- The patient's LAR must provide written, informed consent.
- When developmentally appropriate based on Investigator judgment, the patient should provide written assent.
- Male or female patients 5 to 17 years of age. Currently, only patients aged 13 to 17 years will be eligible for enrollment.
You likely can't join if
- Has a primary psychiatric diagnosis other than ASD. Exceptions include:
- Attention Deficit Hyperactivity Disorder (ADHD). If a patient is taking medication(s) for ADHD, they must be on a stable treatment regimen of these...
- Mild and moderate intellectual disability based on Investigator judgment and DSM-5 criteria (severe and profound intellectual disability are...
- History or current diagnosis of Rett syndrome or Fragile X syndrome;
- 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...
See the full eligibility criteria
- All patients must have a legally authorized representative LAR (eg, parent or legal guardian) who is willing and able to be responsible for the safety and well-being of the patient, provide information about the...
- Able to provide consent as follows:
- The patient's LAR must provide written, informed consent.
- When developmentally appropriate based on Investigator judgment, the patient should provide written assent.
- Male or female patients 5 to 17 years of age. Currently, only patients aged 13 to 17 years will be eligible for enrollment.
- Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of ASD as confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age...
- ABC-I subscale score of \>18 at Screening and Baseline;
- CGI-S score \> 4 with respect to irritability associated with ASD at Screening and Baseline.
- Has a primary psychiatric diagnosis other than ASD. Exceptions include:
- Attention Deficit Hyperactivity Disorder (ADHD). If a patient is taking medication(s) for ADHD, they must be on a stable treatment regimen of these medication(s) for 30 days prior to screening and the treatment regimen...
- Mild and moderate intellectual disability based on Investigator judgment and DSM-5 criteria (severe and profound intellectual disability are excluded).
- History or current diagnosis of Rett syndrome or Fragile X syndrome;
- 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...
- At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or
- The patient is considered to be an imminent danger to themselves or others.
The study team makes the final eligibility decision.
Where it's taking place
- Dothan, Alabama, United States
- Phoenix, Arizona, United States
- Anaheim, California, United States
- Oceanside, California, United States
- Redlands, California, United States
- Upland, California, United States
- West Covina, California, United States
- Colorado Springs, Colorado, United States
- Fort Myers, Florida, United States
- Gainesville, Florida, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Miami Gardens, Florida, United States
- West Palm Beach, Florida, United States
- Savannah, Georgia, United States
- Elgin, Illinois, United States
- Springfield, Illinois, United States
- Boston, Massachusetts, United States
- Saint Charles, Missouri, United States
- Las Vegas, Nevada, United States
+ 10 more site(s).
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 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dothan, Alabama, United States; Phoenix, Arizona, United States; Anaheim, California, United States; Oceanside, California, United States; Redlands, California, United States; Upland, California, United States and 24 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.