Health TrialsbyHealthPanel

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

ConditionParkinson Disease
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • XJN010 Nasal Spray

    Drug

    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.

  • Placebo

    Drug

    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 .

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: XJN010 Nasal SprayExperimental treatment 1 intervention
Group B: XJN010 Nasal Spray blank preparation.Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

MDS-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

Secondary outcomes

1

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
2

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
3

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
4

Maximum blood concentration (Cmax)

Maximum blood concentration (Cmax)

Time frame
0 to 4 hour after administration

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guangzhou Novaken Pharm Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
Apply now