Irritability Associated With Autism Spectrum DisorderPhase 3NCT06690398
Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients
A Phase 3 study testing Lumateperone high dose and Lumateperone low dose in people with Irritability Associated With Autism Spectrum Disorder, run by Intra-Cellular Therapies, Inc. at 35 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Irritability Associated With Autism Spectrum Disorder
- What is being tested?
- Lumateperone high dose and Lumateperone low dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 35 sitesUnited States
- Study dates
- 22 Nov 2024to 19 Jul 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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 patient's condition, and accompany the patient to study visits.
- 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 Children-Present and Lifetime Version (K-SADS-PL);
- 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.
Who cannot join
- 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 is expected to remain stable throughout the study. This must be confirmed by the Investigator and noted in the source records.
- 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 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
- The patient is considered to be an imminent danger to themselves or others.
Trial locations and contacts
35 sites in 1 country. Contact the study team or a site near you to ask about taking part.
35 sites in 1 country
United States35 sites, 28 recruiting
- Recruiting
Advanced Research Center Inc
Anaheim, California, 92805
- Recruiting
REX Clinical Trials LLC
Beaumont, Texas, 77701
- Recruiting
Northwest Clinical Research Center
Bellevue, Washington, 98007
- Completed
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Completed
MCB Clinical Research Centers LLC
Colorado Springs, Colorado, 80910
- Recruiting
Harmonex Neuroscience Research
Dothan, Alabama, 36303
- Recruiting
Revive Research Institute
Elgin, Illinois, 60123
- Completed
North Pointe Psychiatry
Flower Mound, Texas, 76028
- Suspended
Royal Palm Clinical Research
Fort Myers, Florida, 33901
- Recruiting
Sarkis Clinical Trials
Gainesville, Florida, 32607
- Recruiting
Charak Center for Health and Wellness
Garfield, Ohio, 44125
- Recruiting
Kaleidoscope Clinical Research
Houston, Texas, 77089
- Recruiting
Green Leaf Clinical Trials
Jacksonville, Florida, 32258
- Recruiting
Vector Clinical Trials
Las Vegas, Nevada, 89128
- Recruiting
Columbus Clinical Services LLC
Miami, Florida, 33125
- Recruiting
South Florida Research Phase I-IV
Miami, Florida, 33166
- Recruiting
Diverse Clinical Research LLC
Miami, Florida, 33175
- Recruiting
Anchor Medical Research LLC
Miami, Florida, 33176
- Recruiting
Links Clinical Trials
Miami, Florida, 33176
- Recruiting
The Angel Medical Research Corporation
Miami Gardens, Florida, 33169
- Recruiting
Access Clinical Trials
Nashville, Tennessee, 37203
- Recruiting
Excell Research Inc
Oceanside, California, 92056
- Recruiting
Clinical Research Partners, LLC
Petersburg, Virginia, 23805
- Recruiting
Southwest Autism Research and Resource Center
Phoenix, Arizona, 85006
- Recruiting
AIM Trials
Plano, Texas, 75093
- Recruiting
Inland Psychiatric Medical Group Inc
Redlands, California, 92373
- Recruiting
Perceptive Pharma Research
Richmond, Texas, 77407
- Recruiting
Midwest Research Group
Saint Charles, Missouri, 63304
- Recruiting
CenExeli Research LLC
Savannah, Georgia, 31405
- Suspended
Southern Illinois University School of Medicine
Springfield, Illinois, 62701
- Completed
Buena Park Research
Upland, California, 91786
- Recruiting
Next Level Clinical Trials, LLC
West Covina, California, 91790
- Recruiting
Health Synergy Clinical Research
West Palm Beach, Florida, 33407
- Completed
Westlake Brain Health
Westlake, Ohio, 44145
- Recruiting
UMass Memorial Healthcare
Worcester, Massachusetts, 01655
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Lumateperone in the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients 5 to 17 Years of Age
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).
Read the detailed description
The study will be conducted in 3 phases:
- Screening Period (up to 14 days) during which patient eligibility will be assessed.
- Double-blind Treatment Period (DBTP) (6 weeks) during which all patients will be randomized in a 1:1:1 ratio to receive either lumateperone high dose, lumateperone low dose, or placebo as a once daily dose.
- Safety Follow-up Period (1 week) during which all patients will return to the clinic for a safety follow-up (SFU) visit approximately 1 week after the last dose of study drug.
- Being tested
- Lumateperone high dose, Lumateperone low dose, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumateperone high doseDrug
Lumateperone administered orally once daily
Lumateperone low doseDrug
Lumateperone administered orally once daily
PlaceboDrug
Matching Placebo administered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| Lumateperone high dose | Experimental | Lumateperone 42 mg for patients ages 13-17 years old Receives: Drug: Lumateperone high dose |
| Lumateperone low dose | Experimental | Lumateperone 21 mg for patients ages 13-17 years old Receives: Drug: Lumateperone low dose |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aberrant Behavior Checklist - Irritability (ABC-I)
The ABC-I subscale contains 15 items which rate symptoms on a scale ranging from 0 (not at all a problem) to 3 (severe).
Measured: Week 6
Secondary outcomes (1)
Clinical Global Impression-Severity (CGI-S)
The CGI-S is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start22 Nov 2024
- Primary completion21 Jun 2027 (estimated)
- Study completion19 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritability Associated With Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intra-Cellular Therapies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Intra-Cellular Therapies, Inc. Clinical Trial, Study director, Intra-Cellular Therapies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06690398
- Sponsor's protocol ID
- ITI-007-601
- Other IDs
- ITI-007-601
- Status last verified
- Sep 2026
- First submitted
- 13 Nov 2024
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No