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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06442462
Registration number
NCT06442462
Ethics application status
Date submitted
29/05/2024
Date registered
4/06/2024
Date last updated
18/04/2025
Titles & IDs
Public title
Study of SPG302 in Adults With Schizophrenia
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Scientific 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
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Secondary ID [1]
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SPG302-SCZ-201
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Schizophrenia
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Condition category
Condition code
Mental Health
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Schizophrenia
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - SPG302
Treatment: Drugs - Placebo
Active comparator: Active SPG302 to be administered to participants with Schizophrenia - Participants with schizophrenia will be randomized to receive SPG302 300 mg or placebo (two capsules of 150 mg) once daily for six weeks.
Placebo comparator: Placebo comparator to be administered to participants with Schizophrenia - Participants with schizophrenia will be randomized to receive SPG302 300 mg or placebo (two capsules of 150 mg) once daily for six weeks.
Treatment: Drugs: SPG302
small synthetic molecule
Treatment: Drugs: Placebo
Placebo
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Positive and Negative Symptoms Scale (PANSS Score) as determined by clinician
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Assessment method [1]
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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.
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Timepoint [1]
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6 weeks
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Primary outcome [2]
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Electroencephalogram analysis to assess brain electrical activity
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Assessment method [2]
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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.
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Timepoint [2]
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6 weeks
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Primary outcome [3]
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Change in smooth pursuit eye tracking from baseline
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Assessment method [3]
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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.
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Timepoint [3]
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6 weeks
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Secondary outcome [1]
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Safety and tolerability of SPG302 in patients with schizophrenia
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Assessment method [1]
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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).
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Timepoint [1]
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6 weeks
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Secondary outcome [2]
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Change in Global Impressions Improvement scale as determined by clinician
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Assessment method [2]
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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).
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Timepoint [2]
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6 weeks
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Secondary outcome [3]
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Change in MATRICS Consensus Cognitive Battery scale as determined by clinician
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Assessment method [3]
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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.
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Timepoint [3]
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6 weeks
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Secondary outcome [4]
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World Health Organization Quality of Life - Abbreviated Assessment Questionnaire-brief version from baseline
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Assessment method [4]
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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.
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Timepoint [4]
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6 weeks
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Secondary outcome [5]
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Change in Personal and Social Performance from baseline
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Assessment method [5]
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Personal and Social Performance (PSP) evaluates overall functioning in daily life. A higher score indicates higher functioning.
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Timepoint [5]
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6 weeks
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/10/2025
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Actual
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Sample size
Target
32
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Box Hill Hospital - Eastern Health - Box Hill
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Recruitment hospital [2]
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Multidisciplinary Alfred Psychiatry Research Centre (MAPrc) - Melbourne
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Recruitment postcode(s) [1]
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3128 - Box Hill
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Recruitment postcode(s) [2]
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3004 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Spinogenix
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/study/NCT06442462
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Rebecca Ho, MD
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Address
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Multidisciplinary Alfred Psychiatry Research Centre (MAPrc)
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Contact Spinogenix
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Address
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Country
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Phone
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+61 3 9076 6913
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06442462
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