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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05168007
Other study ID # WID-RGC20-P3
Secondary ID
Status Enrolling by invitation
Phase Phase 3
First received
Last updated
Start date November 19, 2021
Est. completion date July 31, 2023

Study information

Verified date December 2021
Source Whanin Pharmaceutical Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 342
Est. completion date July 31, 2023
Est. primary completion date July 17, 2023
Accepts healthy volunteers No
Gender All
Age group 19 Years to 64 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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).
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 for WID-RGC20(Cariprazine) 3mg/day or 6mg/day
The placebo comparator is administered during the double-blind treatment period(6 weeks).

Locations

Country Name City State
Korea, Republic of Whan In Pharm. Seoul

Sponsors (1)

Lead Sponsor Collaborator
Whanin Pharmaceutical Company

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Other Positive And Negative Syndrome Scale(PANSS) total score Change from baseline in Positive And Negative Syndrome Scale(PANSS) total score at Week 1, 2, 3, 4, 5 up to 5 weeks
Other Clinical Global Impressions-Severity(CGI-S) Change from baseline in Clinical Global Impressions-Severity(CGI-S) at Week 1, 2, 3, 4, 5 up to 5 weeks
Other Clinical Global Impressions-Improvement(CGI-I) Clinical Global Impressions-Improvement(CGI-I) at Week 1, 2, 3, 4, 5, 6 up to 6 weeks
Other Positive And Negative Syndrome Scale(PANSS) positive score Change from baseline in Positive And Negative Syndrome Scale(PANSS) positive score by Week 6 up to 6 weeks
Other Positive And Negative Syndrome Scale(PANSS) negative score Change from baseline in Positive And Negative Syndrome Scale(PANSS) negative score by Week 6 up to 6 weeks
Other Positive And Negative Syndrome Scale(PANSS) responder 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
Other Adverse event(AE) Incidence of Adverse event(AE)s by Week 8 up to 8 weeks
Other Suicidal ideation and behavior Incidence of suicidal ideation and behavior by Week 8 up to 8 weeks
Other Extrapyramidal Symptoms(EPS) Incidence of Extrapyramidal Symptoms(EPS) by Week 6 up to 6 weeks
Other Laboratory test Change from baseline in clinical laboratory tests by Week 6 up to 6 weeks
Primary Positive And Negative Syndrome Scale(PANSS) total score Change from baseline in Positive And Negative Syndrome Scale(PANSS) total score at Week 6 at Week 6
Secondary Clinical Global Impressions-Severity(CGI-S) Change from baseline in Clinical Global Impressions-Severity(CGI-S) at Week 6 at Week 6
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