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Testing a nasal spray for times when Parkinson’s medicine wears off

Researchers study the safety and effects of XJN010 nasal spray during periods when usual Parkinson’s medicines no longer control symptoms well.

Testing a treatment or activity · Study reference: NCT07156773

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

This registry record was last updated over six months ago, or its update date is missing. Recruitment may have changed. Confirm with the team before making plans.

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Looking for volunteers

Start (reported actual date)
2025-09-03
Main measurements finished (planned)
2026-03-30
Study finished (planned)
2026-04-30

Planned dates can move. A study finishing does not tell us when a paper will be published.

No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.

Changes we have recorded
  • 2026-10-11 — recruiting

These are dates we observed a change, not necessarily the dates it happened.

Papers connected to this study

No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.

Who can join?

Ages 30 years to 85 years · Does not accept healthy volunteers

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: all

Inclusion Criteria: * 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); * Patients must have no plans for conception from 2 weeks before the first dose until 1 month after the last dose, no plans to donate sperm, and agree to use highly effective contraception methods; * Patients are capable of understanding the study requirements, voluntarily provide written informed consent, and are able to complete the study in compliance with the trial protocol. Exclusion Criteria: * 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; * History of malignancy within the past 5 years, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated with radical surgery, or ductal carcinoma in situ of the breast treated with radical surgery; * History of severe psychiatric disorders within the past year, such as major depression, mania, schizophrenia, or patients with suicidal tendencies; * Patients deemed unsuitable for intranasal administration by the investigator (e.g., severe rhinitis, nasal deformities, etc.); * Those currently receiving centrally nervous system-active medications (e.g., sedatives, hypnotics, antidepressants, anxiolytics), except for those who have maintained a stable dose for at least 30 days prior to screening and can remain stable during the study; * History of orthostatic hypotension or clinically significant hypotension or orthostatic hypotension identified during screening (orthostatic hypotension is defined as a drop in systolic blood pressure ≥20 mmHg or diastolic blood pressure ≥10 mmHg within 3 minutes of standing from a supine position) * Any laboratory test during screening meeting the following criteria: Liver function: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 × upper limit of normal (ULN); or total bilirubin \>2 × ULN; Renal function: Serum creatinine \>178 μmol/L;11. Pregnant or lactating females, or those with a positive pregnancy test during screening; * History of drug or alcohol abuse within the past year; * Participation in a clinical trial and use of an investigational drug within 1 month prior to screening or within 5 drug half-lives (whichever is longer); * Any other condition considered by the investigator to make the patient unsuitable for participation in the trial.
Full study name & original research details

Official study title

Study on Safety and Clinical Efficacy of XJN010 Nasal Spray in Patients With Parkinson's Disease Experiencing Off Episodes

Short title used by the registry

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

Original description

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

Further description from the registry

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.

Conditions reported: Parkinson Disease

Registry records for this study

Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.

Study type
Interventional
Interventions
XJN010 Nasal Spray; Placebo
Phases
PHASE2
Sponsor
Guangzhou Novaken Pharm Co., Ltd.
Start date reported by registry
2025-09-03 (actual)

Registry updated: 2025-09-05 · Status last verified by the registry submitter: 2025-08

Registry records retrieved 2026-10-13 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

HuaLiang Liu, Master · +86+13590957282 · liuhl@gznovaken.com

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

The First Affiliated Hospital of Jinan University (Guangzhou Overseas Chinese Hospital)

Guangzhou, Guangdong, China

Recruiting

Wei Bi, PhD · +86+18028089705 · biwei4762@sina.com

Facility not reported

China

Status not reported

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.