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The purpose of this study is to assess the efficacy, safety, and tolerability of GXV813 in the treatment of an acute episode of schizophrenia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GXV813 | Experimental | GXV813 administered orally. |
|
| Placebo | Placebo Comparator | Placebo administered orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GXV813 | Drug | GXV813 administered orally. |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Positive and Negative Symptom Scale (PANSS) total score | PANSS is a 30-item rating scale used to assess the positive, negative, and general psychopathy symptoms of schizophrenia. PANSS total score ranges from 30 to 120 , where a higher score indicates greater severity. | Baseline, Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with AEs | Assessment of overall safety and tolerability of GXV813 versus placebo in adult inpatients with schizophrenia. This includes monitoring the occurrence and severity of adverse events, results of clinical laboratory tests, changes in vital signs, ECG findings, physical examinations. | Baseline to 6 weeks |
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Inclusion Criteria:
Participant is aged 18 to 65 years, inclusive, at screening
Participant is capable of providing informed consent
Participant has a primary diagnosis of schizophrenia, established by a comprehensive psychiatric evaluation based on the DSM-5 (American Psychiatric Association 2013) criteria and confirmed by Structured Clinical Interview for DSM-5 Clinical Trials version (SCID-5-CT)
Participant is willing and able to be confined to an inpatient setting for the study duration (except for the follow-up period), follow instructions, and comply with the protocol requirements
Participant is experiencing an acute exacerbation or relapse of psychotic symptoms, with onset less than 2 months before screening
Positive and Negative Syndrome Scale total score between 80 and 120, inclusive, at screening a. Score of ≥ 4 (moderate or greater) for ≥ 2 of the following Positive Scale (P) items:
i. Item 1 (P1; delusions)
ii. Item 2 (P2; conceptual disorganization)
iii. Item 3 (P3; hallucinatory behavior)
iv. Item 6 (P6; suspiciousness/persecution)
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | 1-888-669-6682 | novartis.email@novartis.com | |
| Novartis Pharmaceuticals | Contact | +41613241111 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pillar Clinical Research LLC | Recruiting | Bentonville | Arkansas | 72712 | United States |
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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| Drug |
Placebo administered orally. |
|
| Participant clinically significant response |
Proportion of participants achieving a clinically significant response, defined as a ≥30% improvement in PANSS total score or a 1-point improvement in Clinical Global Impression-Severity (CGI-S) score from baseline at week 6, comparing GXV813 to placebo. |
| Baseline, week 6 |
| Change from baseline in PANSS positive sub-score | Assessment of the effect of GXV813 versus placebo on positive symptoms of schizophrenia, measured by the change from baseline in the PANSS positive sub-score at week 6., which measures symptoms that reflect an excess or distortion of normal mental functions. Each item is rated from 1 (absent) to 7 (extreme). | Baseline, week 6 |
| Change from baseline in PANSS negative sub-score | Assessment of the effect of GXV813 versus placebo on negative symptoms of schizophrenia, measured by the change from baseline in the PANSS negative sub-score (this sub-score is calculated by summing the ratings of seven items, each scored from 1 (absent) to 7 (extreme)) at week 6. | Baseline, week 6 |
| Change from baseline in Marder negative factor score | Assessment of the effect of GXV813 versus placebo on negative symptoms of schizophrenia, measured by the change from baseline in the Marder (it is a five-factor structure derived from factor analysis of PANSS data) negative factor score at week 6. | Baseline, week 6 |
| Change from baseline in Clinical Global Impression- Severity (CGI-S) scale | Assessment of the effect of GXV813 versus placebo on overall illness severity, measured by the change from baseline in the CGI-S scale at week 6. The CGI-S scale uses a 7-point rating system, where the highest score indicates greather severity. | Baseline up to week 6 |
| Assess the pharmacokinetics (PK) of GXV813: concentration-time curve (AUC) | The Area Under the Curve (AUC) in pharmacokinetics represents the total drug exposure over time. It is the area under the plot of drug concentration in plasma versus time following administration. | Up to 6 weeks |
| Assess the pharmacokinetics (PK) of GXV813: maximum observed plasma concentration (Cmax) | Cmax is the highest concentration of a drug measured in plasma after administration and before the next dose. | Up to 6 weeks |
| CNRI Los Angeles LLC | Recruiting | Pico Rivera | California | 90660 | United States |
|
| Segal Institute for Clinical Research | Recruiting | Miami | Florida | 33016 | United States |
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| CenExel iResearch | Recruiting | Decatur | Georgia | 30030 | United States |
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| Uptown Research Institute LLC | Recruiting | Chicago | Illinois | 60640 | United States |
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| Pillar Clinical Research LLC | Recruiting | Chicago | Illinois | 60641 | United States |
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| Arch Clinical Trials LLC | Recruiting | St Louis | Missouri | 63141 | United States |
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| Novartis Investigative Site | Recruiting | Kazanlak | Bulgaria | 6100 | Bulgaria |
| Novartis Investigative Site | Recruiting | Lovech | 5500 | Bulgaria |
| Novartis Investigative Site | Recruiting | Sofia | 1377 | Bulgaria |
| Novartis Investigative Site | Recruiting | Veliko Tarnovo | 5000 | Bulgaria |
| Novartis Investigative Site | Recruiting | Vratsa | 3000 | Bulgaria |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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