Share
Save
Study of SPG302 in Adults With Schizophrenia
This Phase 2 study described herein will evaluate the safety, efficacy, tolerability, and pharmacodynamics of SPG302 in adults with a primary diagnosis of schizophrenia.
Study details:
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 five visits to the study site for screening, study procedures, and receipt of investigational medication for use at home.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-08-01
Primary completion: 2025-06-01
Study completion finish: 2025-10-01
Study type
TREATMENT
Phase
PHASE2
Trial ID
NCT06442462
Intervention or treatment
DRUG: SPG302
DRUG: Placebo
Conditions
- • Schizophrenia
Find a site
Closest Location:
Box Hill Hospital - Eastern Health
Research sites nearby
Select from list below to view details:
Box Hill Hospital - Eastern Health
Box Hill, Victoria, Australia
Multidisciplinary Monash Alfred Psychiatry Research Centre
Melbourne, Victoria, Australia
Monash
Melbourne, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ACTIVE_COMPARATOR: Active SPG302 to be administered to participants with Schizophrenia
| DRUG: SPG302
|
PLACEBO_COMPARATOR: Placebo comparator to be administered to participants with Schizophrenia
| DRUG: Placebo
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| Positive and Negative Symptoms Scale (PANSS Score) as determined by clinician | 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. | 6 weeks |
| Electroencephalogram analysis to assess brain electrical activity | 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. | 6 weeks |
| Change in smooth pursuit eye tracking from baseline | 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. | 6 weeks |
Secondary outcome
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
|---|---|---|
| Safety and tolerability of SPG302 in patients with schizophrenia | Number of subjects with treatment related adverse events as assessed by analysis of adverse events including symptoms, and abnormal findings on physical examination, vital signs, ECG, and standard laboratory examination results (SAEs). | 6 weeks |
| Change in Global Impressions Improvement scale as determined by clinician | Change in the Clinical Global Impression of Improvement (CGI-I) is a 3-item observer-rated scale that measures illness severity, global improvement or change, and therapeutic response. It is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). | 6 weeks |
| Change in MATRICS Consensus Cognitive Battery scale as determined by clinician | The MATRICS Consensus Cognitive Battery (MCCB) measures functioning across various cognitive domains through timed assessments. The results of each assessment are summarized for overall cognitive performance. The average score is between 40-60, and a score below 40 indicates lower overall cognitive performance. | 6 weeks |
| World Health Organization Quality of Life - Abbreviated Assessment Questionnaire-brief version from baseline | This is a 26-item questionnaire which collects self-reported data on physical health, psychological health, social relationships, and environmental health. Each section is scored from 1 to 5, with higher scores indicate higher quality of life. Scores from each section are then added together for an overall score, with higher score indicating higher quality of life. | 6 weeks |
| Change in Personal and Social Performance from baseline | Personal and Social Performance (PSP) evaluates overall functioning in daily life. A higher score indicates higher functioning. | 6 weeks |
Frequently Asked Questions
Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol
No questions submitted. Be the first to ask a question!