Study of SPG302 in Adults With Schizophrenia

Last updated: April 17, 2025
Sponsor: Spinogenix
Overall Status: Active - Recruiting

Phase

2

Condition

Tourette's Syndrome

Schizotypal Personality Disorder (Spd)

Mood Disorders

Treatment

Placebo

SPG302

Clinical Study ID

NCT06442462
SPG302-SCZ-201
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 atleast 4 weeks

  • Able and willing to provide written informed consent

Exclusion

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

Study Design

Total Participants: 32
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
August 01, 2024
Estimated Completion Date:
October 31, 2025

Study 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.

Connect with a study center

  • Box Hill Hospital - Eastern Health

    Box Hill, Victoria 3128
    Australia

    Active - Recruiting

  • Monash

    Melbourne, Victoria
    Australia

    Site Not Available

  • Multidisciplinary Alfred Psychiatry Research Centre (MAPrc)

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

  • Multidisciplinary Monash Alfred Psychiatry Research Centre

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

  • CenExel CNS

    Garden Grove, California 92845
    United States

    Active - Recruiting

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