SPG302 for Schizophrenia

Recruiting at 2 trial locations

Overseen By David Walling, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Spinogenix

Must be taking: Antipsychotics

Disqualifiers: Cardiac disease, Malignancy, CNS event, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 9

Duration: 6 weeks

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called SPG302 for individuals with schizophrenia. The aim is to assess the safety and effectiveness of SPG302 compared to a placebo (a pill with no active medicine) over six weeks. Participants will take either SPG302 or a placebo daily. Suitable candidates for this trial have a schizophrenia diagnosis and are currently on one stable antipsychotic medication. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial requires that you are currently taking only one antipsychotic medication and have been on a stable dose for at least 4 weeks. It doesn't specify if you need to stop other medications, but it seems you should continue your current antipsychotic.

Is there any evidence suggesting that SPG302 is likely to be safe for humans?

Research has shown that taking SPG302 daily at 300 mg is generally safe. In past studies, researchers reported no serious side effects linked to the treatment over six months. Most participants tolerated the treatment well, experiencing no major health issues. This suggests it is safe for those considering joining the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about SPG302 for schizophrenia because it offers a potentially novel approach compared to standard treatments like antipsychotics, which often work by blocking dopamine receptors. SPG302 may work through a different mechanism, possibly targeting other pathways involved in schizophrenia, which could lead to fewer side effects or better symptom control. Additionally, the promise of a once-daily oral dose could improve patient adherence, making it a practical option for many.

What evidence suggests that SPG302 might be an effective treatment for schizophrenia?

Research has shown that SPG302 might help treat schizophrenia. Early results indicate that 82% of participants experienced positive outcomes with SPG302. In this trial, participants will receive either SPG302 or a placebo at random. SPG302 is unique because it helps rebuild the brain's connections. Initial findings suggest this could improve symptoms in people with schizophrenia. This represents a hopeful step forward in finding better treatments. ^{3 4 5 6 7}

Who Is on the Research Team?

David Walling, MD

Principal Investigator

CenExel

Are You a Good Fit for This Trial?

Adults aged 18-65 with a primary diagnosis of schizophrenia can join this trial. Participants must be able to consent, have normal or near-normal lab values, and be on just one antipsychotic medication.

Inclusion Criteria

Able and willing to provide written informed consent

Clinical laboratory values within normal range or less than 1.5 times the upper limit of normal

I have been diagnosed with schizophrenia.

Exclusion Criteria

Any physical or psychological condition that prohibits study completion

Receipt of investigational products within 30 days

Blood donation within 30 days

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive SPG302 or placebo once daily for six weeks

6 weeks

6 visits (in-person, weekly)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• SPG302

Trial Overview The study is testing SPG302's safety and effectiveness in treating schizophrenia compared to a placebo. It's a Phase 2 trial, which means it focuses on how well the drug works and checks for side effects.

How Is the Trial Designed?

Group I: Active SPG302 to be administered to participants with Schizophrenia Active Control 1 Intervention

Participants with schizophrenia will be randomized to receive SPG302 300 mg or placebo (two capsules of 150 mg) once daily for six weeks.

Group II: Placebo comparator to be administered to participants with Schizophrenia Placebo Group 1 Intervention

Participants with schizophrenia will be randomized to receive SPG302 300 mg or placebo (two capsules of 150 mg) once daily for six weeks.

Who Is Running the Clinical Trial?

Spinogenix

Lead Sponsor

Trials

6

Recruited

220+

Citations

1. spinogenix.com spinogenix.com/spinogenix-presents-topline-phase-2a-clinical-trial-results-for-spg302-a-first-in-class-als-treatment/

Spinogenix Presents Topline Phase 2a Clinical Trial ... Additional information on the global clinical trials evaluating SPG302 for the treatment of schizophrenia and Alzheimer's disease can be found ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06442462

Study of SPG302 in Adults With Schizophrenia This Phase 2 study will evaluate the safety, efficacy, tolerability, and pharmacodynamics of SPG302 in adults with a primary diagnosis of schizophrenia.

3. spinogenix.com spinogenix.com/spinogenix-announces-positive-first-cohort-results-from-phase-2a-trial-evaluating-spg302-for-alzheimers-disease/

Spinogenix Announces Positive First Cohort Results from ... ... SPG302, the First Synaptic Regenerative Therapy for Schizophrenia. March 30, 2025 · Spinogenix Completes Phase 2 Study of SPG601 for Treatment ...

4. neurologylive.com neurologylive.com/view/preliminary-phase-2-data-support-therapeutic-development-synaptic-regenerative-drug-spg302-als

Preliminary Phase 2 Data Support Therapeutic ... In terms of efficacy, preliminary data showed that 82% of SPG302 ... schizophrenia (NCT06442462). Earlier this year, at the 2025 ...

5. psychiatryonline.org psychiatryonline.org/doi/full/10.1176/appi.pn.2025.05.5.1

Novel Schizophrenia Drug Explored; Daridorexant Treats ... Potential 'Regenerative' Schizophrenia Treatment. Spinogenix Inc. opened its enrollment in March for a Phase 2 trial of SPG302, ...

6. spinogenix.com spinogenix.com/spinogenix-announces-launch-of-a-phase-2-clinical-trial-evaluating-spg302-for-the-treatment-of-schizophrenia/

Spinogenix Announces Launch of a Phase 2 Clinical Trial ... Phase 2 trial is designed to evaluate the safety, efficacy, tolerability, and pharmacodynamics of SPG302 in adults with a primary diagnosis of schizophrenia.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06442462

Study of SPG302 in Adults With Schizophrenia This Phase 2 study will evaluate the safety, efficacy, tolerability, and pharmacodynamics of SPG302 in adults with a primary diagnosis of schizophrenia. This is ...