Study of SPG302 in Adults With Schizophrenia

Schizophrenia Clinical Trial

Official title:

A Randomized, Placebo-controlled, Double-blind Phase 2 Study to Assess the Efficacy, Safety, Tolerability, and Pharmacodynamics of SPG302 in Adult Participants Diagnosed With Schizophrenia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06442462
• Other study ID #: SPG302-SCZ-201
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 2024
• Est. completion date: October 2025

Study information

• Verified date: May 2024
• Source: Spinogenix
• Contact: Leo Chen, Dr.
• Phone: +61 3 9076 6564
• Email: Leo.Chen[@]monash.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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 five visits to the study site for screening, study procedures, and receipt of investigational medication for use at home.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: October 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 45-65
• Primary diagnosis of schizophrenia
• Clinical laboratory values within normal range or < 1.5 times ULN
• Currently prescribed only one antipsychotic medication
• 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
• Serious infection that will not be resolved by first day of study intervention.
• History of clinically significant CNS event or diagnosis in the past 5 years.
• Acute illness within 30 days of Day 1
• History of suicidal behavior or suicidal ideation
• History of chronic alcohol use or substance abuse in the last 5 years
• HIV, hepatitis B and/or hepatitis C positive
• Vaccines within 14 days
• Receipt of investigational products within 30 days
• Blood donation within 30 days
• Pregnant or breastfeeding

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• SPG302
small synthetic molecule
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Spinogenix

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 weeks
Primary	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.	6 weeks
Primary	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.	6 weeks
Secondary	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).	6 weeks
Secondary	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).	6 weeks
Secondary	Change in Global Impressions Severity scale as determined by clinician	Change in the Clinical Global Impression of Severity (CGI-S) 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).	6 weeks
Secondary	World Health Organization Quality of Life - Abbreviated Assessment Questionnaire-brief version from baseline	This is a 26-item questionnaire which collects self-reported data on physical health, psychological health, social relationships, and environmental health. Each section is scored from 1 to 5, with higher scores indicate higher quality of life. Scores from each section are then added together for an overall score, with higher score indicating higher quality of life.	6 weeks
Secondary	Change in BACS (Brief Assessment Cognition Schizophrenia) score from baseline	The BACS is a standardized neuropsychological test to assess the cognitive functions that are often impacted by schizophrenia. These functions are verbal memory, working memory, verbal fluency, processing speed, executive functioning, and motor speed. A higher score indicates higher functioning.	6 weeks
Secondary	Change in Personal and Social Performance from baseline	Personal and Social Performance (PSP) evaluates overall functioning in daily life. A higher score indicates higher functioning.	6 weeks