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NCT06706674
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
Phase 3 trial testing Lumateperone high dose in Irritability Associated With Autism Spectrum Disorder in 174 participants. Currently enrolling.
1 March 2027
Quick facts
| Lead sponsor | Intra-Cellular Therapies, Inc. |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 174 |
| Start date | 6 December 2024 |
| Primary completion | 1 March 2027 |
| Estimated completion | 1 April 2027 |
| Sites | 39 locations across United States |
Drugs / interventions tested
- Lumateperone high dose — full drug profile →
- Lumateperone low dose — full drug profile →
- Placebo
Conditions studied
- Irritability Associated With Autism Spectrum Disorder — all drugs for Irritability Associated With Autism Spectrum Disorder →
Sponsor
Intra-Cellular Therapies, Inc. — full company profile →
Who can join
Adults 5 to 17, any sex, with Irritability Associated With Autism Spectrum Disorder. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Aberrant Behavior Checklist - Irritability (ABC-I)
Time frame: Week 6
The ABC-I subscale contains 15 items which rate symptoms on a scale ranging from 0 (not at all a problem) to 3 (severe).
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06706674
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Intra-Cellular Therapies, Inc. trials
Trials by the same sponsor.
- NCT06786286 — A Mass Balance Study Following Subcutaneous Administration of [14C]-ITI-1284 to Healthy Male Subjects · Phase 1 · completed
- NCT06627413 — Safety, Tolerability, and Pharmacokinetics of Lumateperone Long-Acting Injectable Formulations in Patients With Schizoph · Phase 1 · completed
- NCT06557902 — Safety, Tolerability and Pharmacokinetics of Lumateperone in Pediatric Patients With Autism Spectrum Disorder · Phase 1 · recruiting
- NCT05732194 — Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITI 333 in Healthy Volunteer · Phase 1 · completed
- NCT05470101 — A PET Study Following a Single Oral Dose of ITI-333 in Healthy Subjects · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06706674 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Intra-Cellular Therapies, Inc.
- Last refreshed: 3 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06706674.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing