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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05168007
• Other study ID #: WID-RGC20-P3
• Status: Enrolling by invitation
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Schizophrenia

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