NCT03817528

ITI-007 (Lumateperone Tosylate) for Schizophrenia

Terminated Phase 2 Results posted Last updated 4 November 2021

What this trial tests

Phase 2 trial testing ITI-007 in Schizophrenia in 4 participants. Terminated before completion.

Timeline

1 March 2019

Primary endpoint
23 September 2020

23 September 2020

Quick facts

Lead sponsor	New York State Psychiatric Institute
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	4
Start date	1 March 2019
Primary completion	23 September 2020
Estimated completion	23 September 2020
Sites	1 location across United States

Drugs / interventions tested

• ITI-007 — full drug profile →

Conditions studied

• Schizophrenia — all drugs for Schizophrenia →

Sponsor

New York State Psychiatric Institute

Who can join

Adults 18 to 60, male only, with Schizophrenia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Schizophrenia Symptoms Primary · Change from baseline in Total PANSS score after 6 month treatment

schizophrenia symptoms will be measures using the Positive and Negative Symptom Scale (PANSS) Total PANSS score (range: 30-210). Individual items scored from 1(absent) to 7 (extremely severe). Total PANSS score is sum of the 30 individual items with lowest score (30) indicating all symptoms absent and the maximum score (210) indicating all symptoms rated as extremely severe.

Group	Value	95% CI
ITI-007	11

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events to be reported from time of consent (whether received study drug or not) to 30 days after completion of study treatment (up to 8 months). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

ITI-007

Serious: 1/8 (13%)

Deaths: 0/8

Serious adverse events (1 terms)

Reaction	System	ITI-007
worsening of symptoms	Psychiatric disorders	—

Other adverse events (2 terms — click to expand)

Reaction	System	ITI-007
hypomania	Psychiatric disorders	—
vomiting	Gastrointestinal disorders	—

Most-reported serious reactions: worsening of symptoms.

Data from ClinicalTrials.gov NCT03817528 adverse events section.

Sponsor's own description

The purpose of this study is to offer open label ITI-007 treatment to patients who poorly respond or poorly tolerate approved medications.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. New and emerging treatments for schizophrenia: a narrative review of their pharmacology, efficacy and side effect profile relative to established antipsychotics.
   Lobo MC, Whitehurst TS, Kaar SJ, Howes OD. · · 2022 · cited 74× · PMID 34838528 · DOI 10.1016/j.neubiorev.2021.11.032
2. Psychosis in Alzheimer's Disease.
   Ballard C, Kales HC, Lyketsos C, Aarsland D, et al · · 2020 · cited 38× · PMID 33048274 · DOI 10.1007/s11910-020-01074-y
3. The role of lumateperone in the treatment of schizophrenia.
   Syed AB, Brašić JR. · · 2021 · cited 19× · PMID 34377435 · DOI 10.1177/20451253211034019
4. The Novel Antipsychotic Lumateperone (Iti-007) in the Treatment of Schizophrenia: A Systematic Review.
   Longo G, Cicolini A, Orsolini L, Volpe U. · · 2023 · cited 12× · PMID 38137089 · DOI 10.3390/brainsci13121641