Study Evaluating the Efficacy and Safety of WID-RGC20(Cariprazine) in Patients With Schizophrenia
Primary Purpose
Schizophrenia
Status
Enrolling by invitation
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
WID-RGC20(Cariprazine) 3mg/day
WID-RGC20(Cariprazine) 6mg/day
Placebo for WID-RGC20(Cariprazine) 3mg/day or 6mg/day
Sponsored by
![Whanin Pharmaceutical Company](https://trials-media.s3.amazonaws.com/orgs/whanin-pharmaceutical-company.jpeg)
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
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:
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
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
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
Sites / Locations
- Whan In Pharm.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Cariprazine 3mg/day
Cariprazine 6mg/day
Placebo
Arm Description
WID-RGC20(Cariprazine) 3 mg/day
WID-RGC20(Cariprazine) 6 mg/day
Placebo for WID-RGC20(Cariprazine) 3 mg/day or 6mg/day
Outcomes
Primary Outcome Measures
Positive And Negative Syndrome Scale(PANSS) total score
Change from baseline in Positive And Negative Syndrome Scale(PANSS) total score at Week 6
Secondary Outcome Measures
Clinical Global Impressions-Severity(CGI-S)
Change from baseline in Clinical Global Impressions-Severity(CGI-S) at Week 6
Full Information
NCT ID
NCT05168007
First Posted
November 26, 2021
Last Updated
December 8, 2021
Sponsor
Whanin Pharmaceutical Company
1. Study Identification
Unique Protocol Identification Number
NCT05168007
Brief Title
Study Evaluating the Efficacy and Safety of WID-RGC20(Cariprazine) in Patients With Schizophrenia
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 19, 2021 (Actual)
Primary Completion Date
July 17, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Whanin Pharmaceutical Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
342 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cariprazine 3mg/day
Arm Type
Experimental
Arm Description
WID-RGC20(Cariprazine) 3 mg/day
Arm Title
Cariprazine 6mg/day
Arm Type
Experimental
Arm Description
WID-RGC20(Cariprazine) 6 mg/day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for WID-RGC20(Cariprazine) 3 mg/day or 6mg/day
Intervention Type
Drug
Intervention Name(s)
WID-RGC20(Cariprazine) 3mg/day
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
WID-RGC20(Cariprazine) 6mg/day
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Placebo for WID-RGC20(Cariprazine) 3mg/day or 6mg/day
Intervention Description
The placebo comparator is administered during the double-blind treatment period(6 weeks).
Primary Outcome Measure Information:
Title
Positive And Negative Syndrome Scale(PANSS) total score
Description
Change from baseline in Positive And Negative Syndrome Scale(PANSS) total score at Week 6
Time Frame
at Week 6
Secondary Outcome Measure Information:
Title
Clinical Global Impressions-Severity(CGI-S)
Description
Change from baseline in Clinical Global Impressions-Severity(CGI-S) at Week 6
Time Frame
at Week 6
Other Pre-specified Outcome Measures:
Title
Positive And Negative Syndrome Scale(PANSS) total score
Description
Change from baseline in Positive And Negative Syndrome Scale(PANSS) total score at Week 1, 2, 3, 4, 5
Time Frame
up to 5 weeks
Title
Clinical Global Impressions-Severity(CGI-S)
Description
Change from baseline in Clinical Global Impressions-Severity(CGI-S) at Week 1, 2, 3, 4, 5
Time Frame
up to 5 weeks
Title
Clinical Global Impressions-Improvement(CGI-I)
Description
Clinical Global Impressions-Improvement(CGI-I) at Week 1, 2, 3, 4, 5, 6
Time Frame
up to 6 weeks
Title
Positive And Negative Syndrome Scale(PANSS) positive score
Description
Change from baseline in Positive And Negative Syndrome Scale(PANSS) positive score by Week 6
Time Frame
up to 6 weeks
Title
Positive And Negative Syndrome Scale(PANSS) negative score
Description
Change from baseline in Positive And Negative Syndrome Scale(PANSS) negative score by Week 6
Time Frame
up to 6 weeks
Title
Positive And Negative Syndrome Scale(PANSS) responder
Description
Percentage of subjects with at least 30% reduction in the Positive And Negative Syndrome Scale(PANSS) total score at Week 6 compared with baseline
Time Frame
at Week 6
Title
Adverse event(AE)
Description
Incidence of Adverse event(AE)s by Week 8
Time Frame
up to 8 weeks
Title
Suicidal ideation and behavior
Description
Incidence of suicidal ideation and behavior by Week 8
Time Frame
up to 8 weeks
Title
Extrapyramidal Symptoms(EPS)
Description
Incidence of Extrapyramidal Symptoms(EPS) by Week 6
Time Frame
up to 6 weeks
Title
Laboratory test
Description
Change from baseline in clinical laboratory tests by Week 6
Time Frame
up to 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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
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
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
Facility Information:
Facility Name
Whan In Pharm.
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating the Efficacy and Safety of WID-RGC20(Cariprazine) in Patients With Schizophrenia
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