Lumateperone for Autism

Recruiting at 7 trial locations

Overseen By ITI Clinical Trials

Age: < 18

Sex: Any

Trial Phase: Phase 1

Sponsor: Intra-Cellular Therapies, Inc.

Disqualifiers: Suicidal ideation, Cardiac disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

26 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called lumateperone for children with Autism Spectrum Disorder (ASD) who experience irritability. The main goal is to determine the treatment's safety and how the body processes it. Children aged 5 to under 13 years diagnosed with ASD and who often feel irritable might be suitable candidates. Participants will receive varying doses to identify the safest and most effective amount. As a Phase 1 trial, participants will be among the first to help researchers understand how this new treatment works in people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that lumateperone is likely to be safe for humans?

Research has shown that lumateperone has been tested for safety in children with conditions like schizophrenia and bipolar disorder. One study on children found that lumateperone was generally well-tolerated, with mild side effects such as sleepiness and dry mouth being the most common.

Lumateperone is also approved by the FDA for treating schizophrenia in adults, indicating some established safety. However, since this trial is in the early stages, it primarily aims to gather more detailed safety information for children with Autism Spectrum Disorder. While some existing safety data is available, further testing will clarify how children with autism respond to this medication. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for autism?

Lumateperone is unique because it offers a new approach to treating autism by acting on serotonin, dopamine, and glutamate receptors, potentially providing a more balanced effect on brain chemistry. Unlike the standard treatments for autism, which often include behavioral therapy and medications like antipsychotics or antidepressants, lumateperone has a novel mechanism of action that targets multiple neurotransmitter systems simultaneously. Researchers are excited about lumateperone because it may improve symptoms with fewer side effects, offering a promising alternative to existing therapies. Additionally, its flexible dosage options could allow for tailored treatment for different age groups, enhancing its applicability and effectiveness.

What evidence suggests that lumateperone might be an effective treatment for autism?

Research has shown that lumateperone may help reduce irritability in children with Autism Spectrum Disorder (ASD). Studies have found it can ease symptoms like irritability and psychotic behavior while remaining safe to use. One study specifically noted that lumateperone significantly reduced irritability in young patients with ASD. In this trial, participants will receive lumateperone in different dosages based on age groups to further evaluate its effects. These positive findings suggest that lumateperone might help with some behavioral challenges linked to autism. However, more research is needed to fully understand its benefits for this condition. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for pediatric patients with Autism Spectrum Disorder. Specific details about who can join are not provided, but typically participants must meet certain health criteria and may need parental consent due to their age.

Inclusion Criteria

Ability to swallow capsules

ABC-I subscale score of ≥12 at Screening

CGI-S score of ≥3 at Screening

Exclusion Criteria

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive lumateperone once daily with varying doses over 5 days

1 week

Daily visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Lumateperone

Trial Overview The study is testing the safety, how well it's tolerated, and how the body processes various doses of Lumateperone (a drug) in different forms like capsules or orally disintegrating tablets (ODTs) in children with Autism Spectrum Disorder.

How Is the Trial Designed?

Group I: Group 2 (5 to less than 10 years) Experimental Treatment 4 Interventions

Lumateperone ODT once daily: 5 mg on Days 1 and 2; 5 mg or 10.5 mg on Day 3; 5 mg or 10.5 mg on Days 4 and 5; dosing regimen may be adjusted after the first 6 patients dosed and will not exceed 21 mg in subsequent patients

Group II: Group 1 (10 to less than 13 years) Experimental Treatment 2 Interventions

Lumateperone capsule once daily: 10.5 mg on Days 1 and 2; 10.5 mg or 21 mg on Day 3; 10.5 mg or 21 mg on Days 4 and 5

Lumateperone is already approved in United States for the following indications:

Approved in United States as Caplyta for:

• Schizophrenia
• Bipolar I or II disorder (bipolar depression)

Who Is Running the Clinical Trial?

Intra-Cellular Therapies, Inc.

Lead Sponsor

Trials

42

Recruited

10,700+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06690398

NCT06690398 | Multicenter Study of Lumateperone for the ... Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients. ClinicalTrials.gov ID ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06229210

Study Details | NCT06229210 | Safety and Tolerability Trial ... This is a multicenter, global, 26-week, open-label study to assess the safety and tolerability of lumateperone in pediatric patients with schizophrenia, bipolar ...

3. siumed.edu siumed.edu/trials?f%5B0%5D=treatment%3A392&f%5B1%5D=treatment%3A954&f%5B2%5D=treatment%3A977&f%5B3%5D=treatment%3A1494&f%5B4%5D=treatment%3A148351&page=0

Clinical trials and research studies ... Efficacy and Safety of Lumateperone in the Treatment of Irritability Associated with Autism Spectrum Disorder in Pediatric Patients 5 to 17 Years of Age.

4. withpower.com withpower.com/trial/phase-3-autism-spectrum-disorder-10-2024-82c41

Lumateperone for Irritability in Autism In a 14-week study involving 25 children and adolescents with PDD-NOS or Asperger's disorder, aripiprazole significantly reduced irritability symptoms, with 88% ...

5. synapse.patsnap.com synapse.patsnap.com/article/what-clinical-trials-have-been-conducted-for-lumateperone-tosylate

What clinical trials have been conducted for Lumateperone ... The trial demonstrated that lumateperone effectively reduced psychotic symptoms while maintaining a favorable safety profile, with statistically ...

6. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/542719

Safety, Tolerability and Pharmacokinetics of Lumateperone ... Safety, Tolerability and Pharmacokinetics of Lumateperone in Pediatric Patients With Autism Spectrum Disorder. Phase. I. Age. 5-12. Sponsor.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06557902?term=LUMATEPERONE&rank=10

Safety, Tolerability and Pharmacokinetics of Lumateperone ... 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 ...

8. research-studies.allinforhealth.info research-studies.allinforhealth.info/us/en/listing/12697/safety-and-tolerability-trial/

Safety and Tolerability Trial of Lumateperone in Pediatric This study investigates the safety and tolerability of an investigational medication in young people with schizophrenia or bipolar disorder.

9. ctv.veeva.com ctv.veeva.com/study/multicenter-study-of-lumateperone-for-the-treatment-of-irritability-associated-with-autism-spectrum-1

Multicenter Study of Lumateperone for the Treatment of ... This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients aged 5 to 17 years with a primary diagnosis ...