Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
Study NCT ID:
NCT06596005
Status:
COMPLETED
Last Update Posted:
2025-09-30
First Post:
2024-09-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of TJ0113 Capsule in Patients With Parkinson's Disease
Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Organization:
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 Parkinson's Disease
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
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 Parkinson's 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 Parkinson's 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:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: