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Active, Not Recruiting

NCT Number: NCT06442462

Study of SPG302 in Adults With Schizophrenia

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Box Hill Hospital - Eastern Health, Box Hill, Victoria, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SPG302

Drug

small synthetic molecule

Placebo

Drug

Placebo

Primary outcomes

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

    Time frame: 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.

  2. Electroencephalogram analysis to assess brain electrical activity

    Time frame: 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.

  3. Change in smooth pursuit eye tracking from baseline

    Time frame: 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.

Secondary outcomes

  1. Safety and tolerability of SPG302 in patients with schizophrenia

    Time frame: 6 weeks

    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).

  2. Change in Global Impressions Improvement scale as determined by clinician

    Time frame: 6 weeks

    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).

  3. Change in MATRICS Consensus Cognitive Battery scale as determined by clinician

    Time frame: 6 weeks

    The MATRICS Consensus Cognitive Battery (MCCB) measures functioning across various cognitive domains through timed assessments. The results of each assessment are summarized for overall cognitive performance. The average score is between 40-60, and a score below 40 indicates lower overall cognitive performance.

  4. World Health Organization Quality of Life - Abbreviated Assessment Questionnaire-brief version from baseline

    Time frame: 6 weeks

    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.

  5. Change in Personal and Social Performance from baseline

    Time frame: 6 weeks

    Personal and Social Performance (PSP) evaluates overall functioning in daily life. A higher score indicates higher functioning.

Sponsors and collaborators

Lead sponsor

Spinogenix

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 4, 2024
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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