SPG302 for Schizophrenia

Recruiting at 4 trial locations

Overseen By Emorfia Gavriliids

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Spinogenix

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

Trial Summary

What is the purpose of this trial?

This Phase 2 study described herein will evaluate the safety, efficacy, tolerability, and pharmacodynamics of SPG302 in adults with a primary diagnosis of schizophrenia.

Research Team

Judith Hope, MD

Principal Investigator

Box Hill

Rebecca Ho, MD

Principal Investigator

Multidisciplinary Alfred Psychiatry Research Centre (MAPrc)

Eligibility Criteria

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 am between 18 and 65 years old.

Exclusion Criteria

Any physical or psychological condition that prohibits study completion

Receipt of investigational products within 30 days

Blood donation within 30 days

Timeline

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)

Treatment Details

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.

Participant Groups

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+