Clinical trial NCT06442462: Study of SPG302 in Adults With Schizophrenia
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Schizophrenia
Keywords: synaptogenesis
synapse
dendritic spines
Lead sponsor: Spinogenix
Sponsor class: INDUSTRY
First posted: 2024-06-04
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Positive and Negative Symptoms Scale (PANSS Score) as determined by clinician
timeFrame: 6 weeks
measure: Electroencephalogram analysis to assess brain electrical activity
timeFrame: 6 weeks
measure: Change in smooth pursuit eye tracking from baseline
timeFrame: 6 weeks
Secondary outcomes:
measure: Safety and tolerability of SPG302 in patients with schizophrenia
timeFrame: 6 weeks
measure: Change in Global Impressions Improvement scale as determined by clinician
timeFrame: 6 weeks
measure: Change in MATRICS Consensus Cognitive Battery scale as determined by clinician
timeFrame: 6 weeks
measure: World Health Organization Quality of Life - Abbreviated Assessment Questionnaire-brief version from baseline
timeFrame: 6 weeks
measure: Change in Personal and Social Performance from baseline
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Garden Grove
country: United States
facility: CenExel CNS
state: California
city: Box Hill
country: Australia
facility: Box Hill Hospital - Eastern Health
state: Victoria
city: Melbourne
country: Australia
facility: Multidisciplinary Alfred Psychiatry Research Centre (MAPrc)
state: Victoria
Study officials:
affiliation: Multidisciplinary Alfred Psychiatry Research Centre (MAPrc)
name: Rebecca Ho, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Box Hill
name: Judith Hope, MD
role: PRINCIPAL_INVESTIGATOR
References: