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 of SPG302 in Adults With Schizophrenia

Schizophrenia

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.

SPG302

Placebo

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

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.

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.

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.

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).

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).

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.

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.

Personal and Social Performance (PSP) evaluates overall functioning in daily life. A
higher score indicates higher functioning.

Participants with schizophrenia will be randomized to receive SPG302 300 mg or placebo
(two capsules of 150 mg) once daily for six weeks.

Study of SPG302 in Adults With Schizophrenia

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?