Nasal spray reduces off episodes
- Trial ID
- NCT07156773
- Official Title
- Study on Safety and Clinical Efficacy of XJN010 Nasal Spray in Patients With Parkinson's Disease Experiencing Off Episodes
- Goal
- Nasal spray reduces off episodes
- Phase
- PHASE2
- Status
- RECRUITING
- Sponsor
- Guangzhou Novaken Pharm Co., Ltd.
- Study Type
- INTERVENTIONAL
- Enrollment
- 84 participants
- Conditions
- Parkinson Disease
- Interventions
- XJN010 Nasal Spray, Placebo
Plain-Language Summary
The trial is testing whether XJN010 nasal spray can safely and quickly reduce "off" episodes, the times when Parkinson's motor symptoms return between doses of levodopa. XJN010 is given as a nasal spray so the drug is absorbed rapidly through the nose to act fast during an off period, and it is being studied as an add-on rescue treatment alongside patients' usual levodopa rather than a replacement. Eligible participants are adults 30 to 85 years old with Parkinson's for at least three years, Hoehn‑Yahr stage 1 to 3 when "on," and who show clear levodopa responsiveness. People with prior PD surgery like DBS, major nasal problems, recent serious psychiatric illness or certain unstable medical or lab conditions, pregnant or breastfeeding people, and those on unstable CNS-active medications are excluded.
Locations
- The First Affiliated Hospital of Jinan University (Guangzhou Overseas Chinese Hospital), Guangzhou, Guangdong, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying XJN010 Nasal Spray. The trial is testing whether XJN010 nasal spray can safely and quickly reduce "off" episodes, the times when Parkinson's motor symptoms return between doses of levodopa. XJN010 is given as a nasal spray so the drug is absorbed rapidly through the nose to act fast during an off period, and it is being studied as an add-on rescue treatment alongside patients' usual levodopa rather than a replacement. Eligible participants are adults 30 to 85 years old with Parkinson's for at least three years, Hoehn‑Yahr stage 1 to 3 when "on," and who show clear levodopa responsiveness. People with prior PD surgery like DBS, major nasal problems, recent serious psychiatric illness or certain unstable medical or lab conditions, pregnant or breastfeeding people, and those on unstable CNS-active medications are excluded.
- Who can participate?
- Participants must be between 30 Years and 85 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 2 trial is estimated to last approximately 7 months.