Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) in Pediatric Patients
NCT06706674Phase 3Recruiting
- Lead sponsor
- Intra-Cellular Therapies, Inc. (Industry)
- Enrollment
- 160 (estimated)
- Start date
- 6 Dec 2024
- Primary completion
- 21 Jun 2027 (estimated)
- Study completion
- 21 Jun 2027
- Last update posted
- 25 Sep 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- Quadruple
- Arms
- 3
Interventions
- Lumateperone high dose Drug
- Lumateperone low dose Drug
- Placebo Drug
Conditions and primary outcome
- Irritability Associated With Autism Spectrum Disorder
Primary outcome
Aberrant Behavior Checklist - Irritability (ABC-I) (Week 6)
Posted results on ClinicalTrials.gov
Results posted on ClinicalTrials.gov: No
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
No PubMed citation lists NCT06706674.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT06706674 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
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