Nasal spray could offer quick relief for Parkinson's 'Off' moments
NCT ID NCT07156773
First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study tests a new nasal spray called XJN010 for people with Parkinson's disease who have 'off' episodes—times when their regular medication stops working and symptoms return. The trial will include 84 adults aged 30 to 85 and will measure how well the spray improves movement and how long it takes to switch from 'off' to 'on' state. The goal is to see if the spray is safe and effective for managing these difficult episodes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- XJN010 nasal spray
- What this could lead to
- If successful, this nasal spray could offer a fast-acting way to reduce the duration and severity of 'off' episodes, improving daily function for people with Parkinson's.
- What could go wrong
- This is an early Phase 2 trial with only 84 participants, so results may not apply to everyone. The spray may not work better than placebo, and side effects are still being studied.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 84 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Sep 2025
- Expected to finish
-
Apr 2026
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
30 to 85 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Parkinson disease are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
The First Affiliated Hospital of Jinan University (Guangzhou Overseas Chinese Hospital)
RECRUITINGGuangzhou, Guangdong, 511434, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a massive data registry crack the code of Parkinson's and related brain diseases?
- Reading the Brain's signals to predict who benefits from deep brain stimulation
- Giving Parkinson's patients a say may boost their Brain's ability to learn movement
- Brain scans probe why some Parkinson's patients freeze Mid-Step
- Can tango rewire the brain? dance program tested for Parkinson's and dementia
- Can a workout after walking practice help Parkinson's patients learn better?