Study Evaluating the Efficacy and Safety of WID-RGC20(Cariprazine) in Patients With Schizophrenia

December 8, 2021 updated by: Whanin Pharmaceutical Company

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center, Fixed-Dose, Phase 3 Clinical Trial Evaluating the Efficacy and Safety of WID-RGC20 3 mg/Day and 6 mg/Day in Patients With Acute Psychotic Episode of Schizophrenia

This Study is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center, Fixed-Dose, Phase 3 Clinical Trial Evaluating the Efficacy and Safety of WID-RGC20 3 mg/day and 6 mg/day in Patients with Acute Psychotic Episode of Schizophrenia.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
342

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female patients 19 ≤ age < 65 years
  • At least 1 year of schizophrenia diagnosed according to DSM-5 criteria(295.90)
  • At least 1 psychotic episode within 1 year
  • Current psychotic episode(acute exacerbation of schizophrenia) within 2 weeks
  • 80 ≤ PANSS total score ≤ 120
  • Rating of at least 4(moderate) on at least 2 of the following 4 PANSS positive symptoms
  • CGI-S score ≥ 4
  • Patients who can be hospitalized during the screening period and at least 3 weeks of the initial double-blind treatment phase

Exclusion Criteria:

  1. Psychiatric Criteria

    • Medical history except schizophrenia specified in protocol
    • First-episode psychosis
    • Treatment-resistant schizophrenia within 2 years
    • Positive result from the blood alcohol concentration(BAC) test or the urine drug screen(UDS)
    • Have suicide risk

  2. Treatment-related Criteria

    • Electroconvulsive therapy(ECT) within 12 weeks or Previous lack of response to ECT
    • Concomitant treatment with 3 or more antipsychotics within 12 weeks
    • Treatment with flunitrazepam or LAI antipsychotics less than 1 cycle or clozapine within 24 weeks
    • Treatment with CYP3A4 inducers or potent CYP3A4 inhibitors
    • Treatment with amiodarone or systemic corticosteroids for ≥ 12 weeks within 1 year
    • Required prohibited concomitant medication during the study period
    • Prior participation in any clinical trials of Cariprazine

  3. Other

    • Ophthalmic medical findings or related history(ex. uncontrolled diabetes or hypertension)
    • Abnormal laboratory findings specified in protocol
    • Not suitable for any other reason, as judged by the investigator

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?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Cariprazine 3mg/day
WID-RGC20(Cariprazine) 3 mg/day
Drug: WID-RGC20(Cariprazine) 3mg/day
The initial dose is WID-RGC20(Cariprazine) 1.5mg/day, followed by an up-titration of 1.5mg/day until the target dose(3mg/day) is achieved. The investigational product is administered during the double-blind treatment period(6 weeks).
EXPERIMENTAL: Cariprazine 6mg/day
WID-RGC20(Cariprazine) 6 mg/day
Drug: WID-RGC20(Cariprazine) 6mg/day
The initial dose is WID-RGC20(Cariprazine) 1.5mg/day, followed by an up-titration of 1.5mg/day until the target dose(6mg/day) is achieved. The investigational product is administered during the double-blind treatment period(6 weeks).
PLACEBO_COMPARATOR: Placebo
Placebo for WID-RGC20(Cariprazine) 3 mg/day or 6mg/day
Drug: Placebo for WID-RGC20(Cariprazine) 3mg/day or 6mg/day
The placebo comparator is administered during the double-blind treatment period(6 weeks).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Positive And Negative Syndrome Scale(PANSS) total score
Time Frame: at Week 6
Change from baseline in Positive And Negative Syndrome Scale(PANSS) total score at Week 6
at Week 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical Global Impressions-Severity(CGI-S)
Time Frame: at Week 6
Change from baseline in Clinical Global Impressions-Severity(CGI-S) at Week 6
at Week 6

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Positive And Negative Syndrome Scale(PANSS) total score
Time Frame: up to 5 weeks
Change from baseline in Positive And Negative Syndrome Scale(PANSS) total score at Week 1, 2, 3, 4, 5
up to 5 weeks
Clinical Global Impressions-Severity(CGI-S)
Time Frame: up to 5 weeks
Change from baseline in Clinical Global Impressions-Severity(CGI-S) at Week 1, 2, 3, 4, 5
up to 5 weeks
Clinical Global Impressions-Improvement(CGI-I)
Time Frame: up to 6 weeks
Clinical Global Impressions-Improvement(CGI-I) at Week 1, 2, 3, 4, 5, 6
up to 6 weeks
Positive And Negative Syndrome Scale(PANSS) positive score
Time Frame: up to 6 weeks
Change from baseline in Positive And Negative Syndrome Scale(PANSS) positive score by Week 6
up to 6 weeks
Positive And Negative Syndrome Scale(PANSS) negative score
Time Frame: up to 6 weeks
Change from baseline in Positive And Negative Syndrome Scale(PANSS) negative score by Week 6
up to 6 weeks
Positive And Negative Syndrome Scale(PANSS) responder
Time Frame: at Week 6
Percentage of subjects with at least 30% reduction in the Positive And Negative Syndrome Scale(PANSS) total score at Week 6 compared with baseline
at Week 6
Adverse event(AE)
Time Frame: up to 8 weeks
Incidence of Adverse event(AE)s by Week 8
up to 8 weeks
Suicidal ideation and behavior
Time Frame: up to 8 weeks
Incidence of suicidal ideation and behavior by Week 8
up to 8 weeks
Extrapyramidal Symptoms(EPS)
Time Frame: up to 6 weeks
Incidence of Extrapyramidal Symptoms(EPS) by Week 6
up to 6 weeks
Laboratory test
Time Frame: up to 6 weeks
Change from baseline in clinical laboratory tests by Week 6
up to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Whanin Pharmaceutical Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 19, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 17, 2023

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 26, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 22, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 22, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WID-RGC20-P3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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