Overseen ByRebecca Ho, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Spinogenix
Prior Safety Data
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.
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.
+2 more
Exclusion Criteria
Any physical or psychological condition that prohibits study completion
Receipt of investigational products within 30 days
Blood donation within 30 days
+3 more
Trial 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)
Participant Groups
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.
2Treatment groups
Active Control
Placebo Group
Group I: Active SPG302 to be administered to participants with SchizophreniaActive Control1 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 SchizophreniaPlacebo Group1 Intervention
Participants with schizophrenia will be randomized to receive SPG302 300 mg or placebo (two capsules of 150 mg) once daily for six weeks.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
CenExel CNSGarden Grove, CA
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Who Is Running the Clinical Trial?
SpinogenixLead Sponsor