A Phase 2a, Randomized, Participant- and Investigator blinded, Parallel-group, Placebo-controlled, Multicenter Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults with DSM-5 Schizophrenia (STAR-1)

Conditions

Schizophrenia

Brief summary

Change from baseline in PANSS (Positive and Negative Symptom Scale) total score at 6 weeks

Detailed description

Occurrence and severity of AEs, clinical laboratory tests, vital signs, ECG findings, physical examination, Modified Simpson-Angus Scale (mSAS), Barnes Akathisia Rating Scale (BARS), Abnormal Involuntary Movement Scale (AIMS) and suicidality assessment (Columbia Suicide Severity Rating Scale C-SSRS), Participant response; response is defined as clinically significant reduction in total PANSS (≥30% improvement in PANSS total score),OR a 1-point difference CGI-S-score at week 6., Change from baseline in PANSS positive subscore at week 6, Change from baseline in PANSS negative subscore and Marder negative factor score at week 6, Change from baseline in Clinical Global Impression‒Severity (CGI-S) scale at week 6, PK parameters such as but not limited to area under the plasma concentration-time curve (AUC), maximum observed plasma concentration (Cmax)

Related papers

No related papers found yet.

Interventions

DRUGGXV813

DRUGPlacebo 0 mg Hard gelatin capsule

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Change from baseline in PANSS (Positive and Negative Symptom Scale) total score at 6 weeks	—

Secondary

Measure	Time frame
Occurrence and severity of AEs, clinical laboratory tests, vital signs, ECG findings, physical examination, Modified Simpson-Angus Scale (mSAS), Barnes Akathisia Rating Scale (BARS), Abnormal Involuntary Movement Scale (AIMS) and suicidality assessment (Columbia Suicide Severity Rating Scale C-SSRS), Participant response; response is defined as clinically significant reduction in total PANSS (≥30% improvement in PANSS total score),OR a 1-point difference CGI-S-score at week 6., Change from baseline in PANSS positive subscore at week 6, Change from baseline in PANSS negative subscore and Marder negative factor score at week 6, Change from baseline in Clinical Global Impression‒Severity (CGI-S) scale at week 6, PK parameters such as but not limited to area under the plasma concentration-time curve (AUC), maximum observed plasma concentration (Cmax)	—

Measure

Time frame

Occurrence and severity of AEs, clinical laboratory tests, vital signs, ECG findings, physical examination, Modified Simpson-Angus Scale (mSAS), Barnes Akathisia Rating Scale (BARS), Abnormal Involuntary Movement Scale (AIMS) and suicidality assessment (Columbia Suicide Severity Rating Scale C-SSRS), Participant response; response is defined as clinically significant reduction in total PANSS (≥30% improvement in PANSS total score),OR a 1-point difference CGI-S-score at week 6., Change from baseline in PANSS positive subscore at week 6, Change from baseline in PANSS negative subscore and Marder negative factor score at week 6, Change from baseline in Clinical Global Impression‒Severity (CGI-S) scale at week 6, PK parameters such as but not limited to area under the plasma concentration-time curve (AUC), maximum observed plasma concentration (Cmax)

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Outcome results

None listed