Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06596005
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
Efficacy and Safety of TJ0113 Capsule in Patients With Parkinsons Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-blind Placebo Parallel-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of TJ0113 Capsule in Patients With Early-stage Parkinsons Disease
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A randomized double-blind placebo parallel-controlled Phase II clinical trial to evaluate the efficacy and safety of TJ0113 capsule in patients with early-stage Parkinsons disease
Detailed Description:
This study is a randomized double-blind placebo parallel-controlled phase II clinical trial which is designed to assess the efficacy and safety of TJ0113 capsules in the treatment of patients with early-stage Parkinsons disease PD It is planned to include approximately 150 subjects with early-stage PD who will be randomized in a 1 1 ratio into two cohorts Cohort 1 200 mg dose group Cohort 2 400 mg dose group Within each cohort subjects who have been successfully screened will be randomly assigned to TJ0113 capsule group and the placebo group in a ratio of 2 1 within each stratum based on a stratification factor whether they have been receiving levodopa the background medication for PD yes vs no at a stable dose Among them approximately 50 subjects will receive TJ0113 capsules and approximately 25 subjects will receive the placebo In this study there will be approximately 50 subjects in each of the TJ0113 capsules 200 mg group TJ0113 capsules 400 mg group and the placebo group
After randomization subjects will receive the oral administration of TJ0113 capsules or the placebo for 12 consecutive weeks and continue to receive follow-up visits for 1 week after the end of treatment For subjects who have been receiving the anti-PD drug at a stable dose for at least 4 weeks prior to study entry the original regimen of the background medication for PD should be maintained during the study
After randomization subjects will receive the oral administration of TJ0113 capsules or the placebo for 12 consecutive weeks and continue to receive follow-up visits for 1 week after the end of treatment For subjects who have been receiving the anti-PD drug at a stable dose for at least 4 weeks prior to study entry the original regimen of the background medication for PD should be maintained during the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None