drugset / Trial / NCT06596005
Efficacy and Safety of TJ0113 Capsule in Patients With Parkinson's Disease
Phase 2
Completed
149 enrolled
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou PhecdaMed Co., Ltd. · collabHuzhou Central Hospital · collabSir Run Run Shaw Hospital · collabTaizhou Hospital · collabTaizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University · collabThe Second Affiliated Hospital of Jiaxing University · collabWenzhou Central Hospital · collab
RandomizedParallel-groupQuadruple-blindTreatment
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
Timeline
- Start
- 2024-09-18
- Primary completion
- 2025-09-03
- Completion
- 2025-09-09
Outcome
Met primary endpoint
registry analysis (other test); TJ0113 200mg vs Placebo; p <0.0001; Difference in least squares means -6.37 (95% CI -8.09 to -4.64) NCT06596005 ↗
registry analysis (other test); TJ0113 400mg vs Placebo; p <0.0001; Difference in least squares means -6.70 (95% CI -8.45 to -4.95) NCT06596005 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TJ0113 | Unknown | 200 mg | Oral |
| Subject | TJ0113 | Unknown | 400 mg | Oral |