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

Launched by GUANGZHOU NOVAKEN PHARM CO., LTD. ·

Keywords

ClinConnect Summary

This trial is studying the nasal spray XJN010 to see if it is safe, how the body handles it, and whether it can help people with Parkinson’s disease who experience “off” episodes (times when their usual medication wears off and symptoms return). It’s a phase 2, randomized, single-blind, placebo-controlled study done at multiple centers in China. About 84 adults will be randomly assigned to receive either the XJN010 nasal spray or a placebo (inactive spray) in parallel groups. The main goal is to look at motor symptoms after 14 days of treatment using a standard rating scale, where lower scores mean better movement. Secondary goals include how often patients move from OFF to ON and stay there by day 14, how long OFF periods last compared with baseline, quality of life scores, and the highest drug level in the blood after dosing. The study is currently recruiting and is expected to finish around April 2026.

Eligible participants are adults aged 30–85 with Parkinson’s disease for at least 3 years, who have mild to moderate symptoms during ON (Hoehn‑Yahr stage 1–3) and show a good response to levodopa (at least 30% improvement in motor scores when moving from OFF to ON after morning levodopa). To participate, people must not have certain conditions or circumstances (such as planned brain surgery, severe nasal problems, certain other medicines, significant liver or kidney issues, pregnancy, or recent cancer or major psychiatric illness) and must be able to provide informed consent. The study is based at The First Affiliated Hospital of Jinan University in Guangzhou, and is sponsored by Guangzhou Novaken Pharma.

Gender

ALL

Eligibility criteria