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Clinical Trials in the USA / NCT06442462
Active, not recruiting Phase 2

Study of SPG302 in Adults With Schizophrenia

NCT06442462 · tracked via the Priya Life Science USA tracker
Sponsor
Spinogenix
Phase
Phase 2
Started
2024-08-01
Last updated
2026-02-06

Condition(s) studied

Schizophrenia

Investigational drug(s) / intervention(s)

SPG302 →Placebo

SPG302: small synthetic molecule

Placebo: Placebo

Study summary

This Phase 2 study described herein will evaluate the safety, efficacy, tolerability, and pharmacodynamics of SPG302 in adults with a primary diagnosis of schizophrenia.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * Age 18-65 * Primary diagnosis of schizophrenia * Clinical laboratory values within normal range or \< 1.5 times ULN * Currently prescribed only one antipsychotic medication, with stable dose for at least 4 weeks * Able and willing to provide written informed consent Exclusion Criteria: * Any physical or psychological condition that prohibits study completion * Known cardiac disease * Active or history of malignancy in the past 5 years * History of clinically significant CNS event or diagnosis in the past 5 years. * Receipt of investigational products within 30 days * Blood donation within 30 days

Primary outcome measure(s)

  • Positive and Negative Symptoms Scale (PANSS Score) as determined by clinician — 6 weeks
    The PANSS is a scale to measure symptom severity of schizophrenia. Thirty symptoms of schizophrenia are evaluated by a clinician on a seven point sale, with 1 = absence of symptoms and 7 = extremely severe symptoms. This study will rate each score change by calculating the difference between baseline scale and completion of study intervention.
  • Electroencephalogram analysis to assess brain electrical activity — 6 weeks
    Electroencephalograms (EEG) will provide a non-invasive measurement of brain activity. This test will be used to measure specific brain responses to stimuli, including attention and decision making electrical activity and detection of unexpected changes in the auditory environment.
  • Change in smooth pursuit eye tracking from baseline — 6 weeks
    Participants will follow visual targets on a computer screen to assess for accuracy of following the item, and smoothness of eye movements. The visual target on the computer screen will follow several different tracking patterns and at various speeds.

Trial sites (3)

FacilityCityRegionStatus
CenExel CNS Garden Grove California
Box Hill Hospital - Eastern Health Box Hill Victoria
Multidisciplinary Alfred Psychiatry Research Centre (MAPrc) Melbourne Victoria

Other trials for the same condition

Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With Schizophrenia Recruiting
Randomized Withdrawal Study in Patients With Schizophrenia Recruiting
Evaluation of Treatment Satisfaction and KarXT Utilization Registry (RESKU) Recruiting
Study of ALTO-101 in Patients With Schizophrenia Recruiting
Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06442462 on ClinicalTrials.gov ↗ ← All trials in the USA