Study of SPG302 in Adults With Schizophrenia

Phase 2Active Not RecruitingNCT06442462

Spinogenix32 enrolled

Overview

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

This Phase 2 study will evaluate the safety, efficacy, tolerability, and pharmacodynamics of SPG302 in adults with a primary diagnosis of schizophrenia. This is a randomized, placebo-controlled study of SPG302 administered once daily for six weeks. This study will entail weekly visits to the study site for screening, study procedures, and receipt of investigational medication for use at home.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Schizophrenia

Interventions

SPG302DRUG

small synthetic molecule

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (3)

CenExel CNS

Garden Grove, California, United States

Box Hill Hospital - Eastern Health

Box Hill, Victoria, Australia

Multidisciplinary Alfred Psychiatry Research Centre (MAPrc)

Melbourne, Victoria, Australia

Outcomes

Primary Outcomes

Positive and Negative Symptoms Scale (PANSS Score) as determined by clinician

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.

Time frame: 6 weeks

Electroencephalogram analysis to assess brain electrical activity

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.

Time frame: 6 weeks

Change in smooth pursuit eye tracking from baseline

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.

Time frame: 6 weeks

Secondary Outcomes

Safety and tolerability of SPG302 in patients with schizophrenia

Number of subjects with treatment related adverse events as assessed by analysis of adverse events including symptoms, and abnormal findings on physical examination, vital signs, ECG, and standard laboratory examination results (SAEs).

Time frame: 6 weeks

Change in Global Impressions Improvement scale as determined by clinician

Change in the Clinical Global Impression of Improvement (CGI-I) is a 3-item observer-rated scale that measures illness severity, global improvement or change, and therapeutic response. It is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients).

Data from ClinicalTrials.gov

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