The Study is Being Conducted to Evaluate the Safety and Efficacy of XJN010 Nasal Spray in Patients With Parkinson's Disease Experiencing Off Episodes

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age30-85
SponsorGuangzhou Novaken Pharm Co., Ltd.

About this trial

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

Eligibility criteria

Qualifiers

Male or female patients aged 30 to 85 years (inclusive);

Diagnosed with Parkinson's disease according to the Chinese Diagnostic Criteria for Parkinson's Disease (2016), with a disease duration of at least 3 years;

Patients with a Hoehn-Yahr stage rating (during "on" periods) of 1 to 3;

Demonstrates responsiveness to levodopa (≥30% improvement/decrease in UPDRS-III score (motor examination) from "off" to "on" state following morning administration of routine levodopa dose);

Disqualifiers

Individuals with motor impairments that severely affect their ability to participate in and perform study procedures;

Those exhibiting dyskinesia that significantly impacts daily functioning;

Known hypersensitivity/allergic reaction or intolerance to any component of the investigational drug;

Previous Parkinson's disease (PD) surgery (including but not limited to deep brain stimulation or brain cell transplantation) or planned PD surgery during the trial period;

Trial design

Treatments tested in this trial

  • XJN010 Nasal Spray
  • Placebo

Treatment groups

84 Participants
are divided into 2 treatment groups