NCT07156773

The Study is Being Conducted to Evaluate the Safety and Efficacy of XJN010 Nasal Spray in Patients With Parkinson's Disease Experiencing Off Episodes

Study on Safety and Clinical Efficacy of XJN010 Nasal Spray in Patients With Parkinson's Disease Experiencing Off Episodes

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Guangzhou Novaken Pharm Co., Ltd. · Industry
• Sex: All
• Age: 30 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The study is being conducted to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of XJN010 Nasal Spray in Patients with Parkinson's Disease Experiencing Off Episodes

Detailed description

A multi-center, randomized, double-blind, placebo-controlled trial design was adopted. Qualified subjects will be selected and enter the treatment period (D1 to D14). A total of 84 patients were included, and they were randomly assigned to the nasal spray group or the placebo group in a ratio of 3:1:3:1:3:1.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	XJN010 Nasal Spray	In the XJN010 Nasal Spray group, subjects will receive XJN010 Nasal Spray，Based on the frequency of the "off" periods experienced by Parkinson's patients.
DRUG	Placebo	In the XJN010 Nasal Spray blank preparation group, subjects will receive XJN010 Nasal Spray blank preparation, Based on the frequency of the "off" periods experienced by Parkinson's patients .

Timeline

• Start date: 2025-09-03
• Primary completion: 2026-03-30
• Completion: 2026-04-30
• First posted: 2025-09-05
• Last updated: 2025-09-05

Locations

1 site across 1 country: China