XJN010 Nasal Spray for Parkinson's (NCT07156773)
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 goal is to see if a new nasal spray can be given safely and can reduce "off" episodes, the times when Parkinson's symptoms return as regular medication wears off. Participants are randomly assigned to get the nasal spray or a placebo spray, and neither they nor the study team know who gets which while researchers check safety, how the body handles the spray, and whether it helps symptoms. The trial plans to enroll 84 people aged 30 to 85 who have had Parkinson's for at least three years, have mild to moderate disease during their "on" times (stage 1 to 3 on a common Parkinson's scale), and who show at least a 30% improvement in motor symptoms after their usual morning levodopa dose. People with major nasal problems, recent serious psychiatric illness, recent cancer, prior Parkinson's surgery, pregnancy, or certain abnormal lab results are not eligible, and participants must agree to use effective birth control if needed.
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 goal is to see if a new nasal spray can be given safely and can reduce "off" episodes, the times when Parkinson's symptoms return as regular medication wears off. Participants are randomly assigned to get the nasal spray or a placebo spray, and neither they nor the study team know who gets which while researchers check safety, how the body handles the spray, and whether it helps symptoms. The trial plans to enroll 84 people aged 30 to 85 who have had Parkinson's for at least three years, have mild to moderate disease during their "on" times (stage 1 to 3 on a common Parkinson's scale), and who show at least a 30% improvement in motor symptoms after their usual morning levodopa dose. People with major nasal problems, recent serious psychiatric illness, recent cancer, prior Parkinson's surgery, pregnancy, or certain abnormal lab results are not eligible, and participants must agree to use effective birth control if needed.
- 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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This Phase 2 trial is estimated to last approximately 7 months.
- 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.
- 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.
- Will I get a placebo in this trial?
- This trial has 2 groups, and 1 is a placebo group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the placebo group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.