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
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 32
- Locations
- 4
- Primary Endpoint
- Positive and Negative Symptoms Scale (PANSS Score) as determined by clinician
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Active SPG302 to be administered to participants with Schizophrenia
Participants with schizophrenia will be randomized to receive SPG302 300 mg or placebo (two capsules of 150 mg) once daily for six weeks.
Intervention: SPG302 (Drug)
Placebo comparator to be administered to participants with Schizophrenia
Participants with schizophrenia will be randomized to receive SPG302 300 mg or placebo (two capsules of 150 mg) once daily for six weeks.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Positive and Negative Symptoms Scale (PANSS Score) as determined by clinician
Time Frame: 6 weeks
The PANSS is a scale to measure symptom severity of schizophrenia. Thirty symptoms of schizophrenia are evaluated by a clinician on a seven point sale, with 1 = absence of symptoms and 7 = extremely severe symptoms. This study will rate each score change by calculating the difference between baseline scale and completion of study intervention.
Electroencephalogram analysis to assess brain electrical activity
Time Frame: 6 weeks
Electroencephalograms (EEG) will provide a non-invasive measurement of brain activity. This test will be used to measure specific brain responses to stimuli, including attention and decision making electrical activity and detection of unexpected changes in the auditory environment.
Change in smooth pursuit eye tracking from baseline
Time Frame: 6 weeks
Participants will follow visual targets on a computer screen to assess for accuracy of following the item, and smoothness of eye movements. The visual target on the computer screen will follow several different tracking patterns and at various speeds.
Secondary Outcomes
- Safety and tolerability of SPG302 in patients with schizophrenia(6 weeks)
- Change in Global Impressions Improvement scale as determined by clinician(6 weeks)
- Change in MATRICS Consensus Cognitive Battery scale as determined by clinician(6 weeks)
- World Health Organization Quality of Life - Abbreviated Assessment Questionnaire-brief version from baseline(6 weeks)
- Change in Personal and Social Performance from baseline(6 weeks)