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
A multi-center, randomized, double-blind, placebo-controlled trial design was adopted. Qualified subjects will be selected and enter the treatment period (D1 to D14). A total of 84 patients were included, and they were randomly assigned to the nasal spray group or the placebo group in a ratio of 3:1:3:1:3:1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
84
In the XJN010 Nasal Spray group, subjects will receive XJN010 Nasal Spray,Based on the frequency of the "off" periods experienced by Parkinson's patients.
In the XJN010 Nasal Spray blank preparation group, subjects will receive XJN010 Nasal Spray blank preparation, Based on the frequency of the "off" periods experienced by Parkinson's patients .
The First Affiliated Hospital of Jinan University (Guangzhou Overseas Chinese Hospital)
Guangzhou, Guangdong, China
RECRUITINGMDS-UPDRS part III score
MDS - Unified Parkinson's Disease Rating Scale Part III,The minimum score is 0 and the maximum is 4, higher scores mean a worse outcome.
Time frame: Day14
The proportion of patients whose condition progresses from the "OFF" phase to the "on" phase and remains in the "on" phase state
The proportion of patients whose condition progresses from the "closed" phase to the "open" phase and remains in the "open" phase state
Time frame: Day14
The duration of the "OFF" period compared to the baseline value
The duration of the "OFF" period compared to the baseline value
Time frame: Day14
PDQ-39 score
Parkinson's disease Questionnaire-39 score,The minimum score is 0 and the maximum is 4, higher scores mean a worse outcome.
Time frame: Day14
Maximum blood concentration (Cmax)
Maximum blood concentration (Cmax)
Time frame: 0 to 4 hour after administration
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