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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
6/08/2024

Titles & IDs
Public title
Study of SPG302 in Adults With Schizophrenia
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
Secondary ID [1] 0 0
SPG302-SCZ-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Positive and Negative Symptoms Scale (PANSS Score) as determined by clinician
Timepoint [1] 0 0
6 weeks
Primary outcome [2] 0 0
Electroencephalogram analysis to assess brain electrical activity
Timepoint [2] 0 0
6 weeks
Primary outcome [3] 0 0
Change in smooth pursuit eye tracking from baseline
Timepoint [3] 0 0
6 weeks
Secondary outcome [1] 0 0
Safety and tolerability of SPG302 in patients with schizophrenia
Timepoint [1] 0 0
6 weeks
Secondary outcome [2] 0 0
Change in Global Impressions Improvement scale as determined by clinician
Timepoint [2] 0 0
6 weeks
Secondary outcome [3] 0 0
Change in Global Impressions Severity scale as determined by clinician
Timepoint [3] 0 0
6 weeks
Secondary outcome [4] 0 0
World Health Organization Quality of Life - Abbreviated Assessment Questionnaire-brief version from baseline
Timepoint [4] 0 0
6 weeks
Secondary outcome [5] 0 0
Change in BACS (Brief Assessment Cognition Schizophrenia) score from baseline
Timepoint [5] 0 0
6 weeks
Secondary outcome [6] 0 0
Change in Personal and Social Performance from baseline
Timepoint [6] 0 0
6 weeks

Eligibility
Key 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
Minimum age
45 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2025
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Multidisciplinary Monash Alfred Psychiatry Research Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Spinogenix
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Leo Chen, Dr.
Address 0 0
The Alfred
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Emorfia Gavrilidis
Address 0 0
Country 0 0
Phone 0 0
+61 3 9076 6564
Fax 0 0
Email 0 0
emmy.gavrilidis@monash.edu
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