Actively Recruiting
The Study is Being Conducted to Evaluate the Safety and Efficacy of XJN010 Nasal Spray in Patients With Parkinson's Disease Experiencing Off Episodes
Led by Guangzhou Novaken Pharm Co., Ltd. · Updated on 2025-09-05
84
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
The Study is Being Conducted to Evaluate the Safety and Efficacy of XJN010 Nasal Spray in Patients With Parkinson's Disease Experiencing Off Episodes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 30 to 85 years (inclusive)
- Diagnosed with Parkinson's disease for at least 3 years according to Chinese Diagnostic Criteria (2016)
- Hoehn-Yahr stage 1 to 3 during "on" periods
- Shows at least 30% improvement in motor symptoms after levodopa
- No plans for conception from 2 weeks before first dose until 1 month after last dose and agrees to use effective contraception
- Able to understand study requirements, provide informed consent, and comply with study protocol
You will not qualify if you...
- Severe motor impairments preventing participation in study procedures
- Dyskinesia significantly affecting daily life
- Known allergy or intolerance to study drug components
- Previous or planned Parkinson's disease surgery during trial
- History of malignancy in past 5 years except certain treated cancers
- Severe psychiatric disorders in past year or suicidal tendencies
- Unsuitable for intranasal administration (e.g., severe rhinitis, nasal deformities)
- Use of CNS-active medications unless stable dose for 30+ days before screening
- History or presence of orthostatic hypotension as defined during screening
- Abnormal liver or kidney function tests beyond specified limits
- Pregnant, lactating, or positive pregnancy test
- History of drug or alcohol abuse in past year
- Participation in other clinical trials with investigational drugs within 1 month or 5 half-lives
- Any other condition deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Jinan University (Guangzhou Overseas Chinese Hospital)
Guangzhou, Guangdong, China, 511434
Actively Recruiting
Research Team
H
HuaLiang Liu, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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