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
Summary For Families
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.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.