SchizophreniaPhase 2NCT06442462
Study of SPG302 in Adults With Schizophrenia
A Phase 2 study testing SPG302 in people with Schizophrenia, run by Spinogenix at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- SPG302
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Aug 2024to Mar 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Australia2 sites
Box Hill Hospital - Eastern Health
Box Hill, Victoria, 3128
Multidisciplinary Alfred Psychiatry Research Centre (MAPrc)
Melbourne, Victoria, 3004
About this study
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
This Phase 2 study described herein will evaluate the safety, efficacy, tolerability, and pharmacodynamics of SPG302 in adults with a primary diagnosis of schizophrenia.
Read the detailed 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 weekly visits to the study site for screening, study procedures, and receipt of investigational medication for use at home.
- Conditions
- Schizophrenia
- Being tested
- SPG302, Placebo
- Keywords
- synaptogenesis, synapse, dendritic spines
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPG302Drug
small synthetic molecule
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Active SPG302 to be administered to participants with Schizophrenia | Active comparator | Participants with schizophrenia will be randomized to receive SPG302 300 mg or placebo (two capsules of 150 mg) once daily for six weeks. Receives: Drug: SPG302 |
| Placebo comparator to be administered to participants with Schizophrenia | Placebo comparator | Participants with schizophrenia will be randomized to receive SPG302 300 mg or placebo (two capsules of 150 mg) once daily for six weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 weeks
Secondary outcomes (5)
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).
Measured: 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).
Measured: 6 weeks
Change in MATRICS Consensus Cognitive Battery scale as determined by clinician
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.
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start1 Aug 2024
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spinogenix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Walling, MD, Principal investigator, CenExel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442462
- Sponsor's protocol ID
- SPG302-SCZ-201
- Status last verified
- Jul 2025
- First submitted
- 29 May 2024
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06442462
- Acronym / sponsor ID
- SPG302-SCZ-201
- Conditions
- Schizophrenia
- Keywords
- synaptogenesis, synapse, dendritic spines
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- SpinogenixIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 2 study described herein will evaluate the safety, efficacy, tolerability, and pharmacodynamics of SPG302 in adults with a primary diagnosis of schizophrenia.
Detailed 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 weekly visits to the study site for screening, study procedures, and receipt of investigational medication for use at home.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active SPG302 to be administered to participants with Schizophrenia | Active comparator | Drug: SPG302Participants with schizophrenia will be randomized to receive SPG302 300 mg or placebo (two capsules of 150 mg) once daily for six weeks. |
| Placebo comparator to be administered to participants with Schizophrenia | Placebo comparator | Drug: PlaceboParticipants with schizophrenia will be randomized to receive SPG302 300 mg or placebo (two capsules of 150 mg) once daily for six weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPG302small synthetic molecule | Drug | Active SPG302 to be administered to participants with Schizophrenia |
| PlaceboPlacebo | Drug | Placebo comparator to be administered to participants with Schizophrenia |
Primary outcome
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.
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.
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.
5 secondary outcomes
Safety and tolerability of SPG302 in patients with schizophrenia
Time frame: 6 weeks
Change in Global Impressions Improvement scale as determined by clinician
Time frame: 6 weeks
Change in MATRICS Consensus Cognitive Battery scale as determined by clinician
Time frame: 6 weeks
World Health Organization Quality of Life - Abbreviated Assessment Questionnaire-brief version from baseline
Time frame: 6 weeks
Change in Personal and Social Performance from baseline
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Walling, MD principal investigator
CenExel
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SPG302 in people with Schizophrenia, run by Spinogenix at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive and Negative Symptoms Scale (PANSS Score) as determined by clinician (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.