Evaluating SPG302 for treating schizophrenia in adults
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 study is testing a new medication called SPG302 to see if it can help adults with schizophrenia feel better compared to a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Spinogenix Industry-sponsored |
| Locations | 3 sites (Garden Grove, California and 2 other locations) |
| Trial ID | NCT06442462 on ClinicalTrials.gov |
What this trial studies
This Phase 2 study aims to assess the safety, efficacy, tolerability, and pharmacodynamics of SPG302 in adults diagnosed with schizophrenia. Participants will be randomly assigned to receive either SPG302 or a placebo once daily for six weeks. The study involves weekly visits for screening and medication administration, ensuring close monitoring of participants throughout the trial. The goal is to gather data on how well SPG302 works compared to a placebo in managing symptoms of schizophrenia.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a primary diagnosis of schizophrenia who are stable on one antipsychotic medication.
Not a fit: Patients with significant physical or psychological conditions, known cardiac disease, or a history of malignancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for adults suffering from schizophrenia.
How similar studies have performed: Other studies exploring synaptogenesis and related treatments have shown promise, but this specific approach with SPG302 is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Garden Grove, California and 2 other locations
- CenExel CNS — Garden Grove, California, United States (Recruiting)
- Box Hill Hospital - Eastern Health — Box Hill, Victoria, Australia (Recruiting)
- Multidisciplinary Alfred Psychiatry Research Centre (MAPrc) — Melbourne, Victoria, Australia (Recruiting)
Study contacts
- Principal investigator: Rebecca Ho, MD — Multidisciplinary Alfred Psychiatry Research Centre (MAPrc)
- Study coordinator: Contact Spinogenix
- Email: contact@spinogenix.com
- Phone: +61 3 9076 6913
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.