---
title: Nasal spray reduces off episodes
nct_id: NCT07156773
phase: PHASE2
status: RECRUITING
sponsor: Guangzhou Novaken Pharm Co., Ltd.
study_type: INTERVENTIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT07156773"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07156773"
last_fetched: "2026-05-10T14:03:56.134Z"
source: "Parkinson's Pathways (curated)"
---
# Nasal spray reduces off episodes

**Goal (in five words):** Nasal spray reduces off episodes

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

**Trial ID:** [NCT07156773](https://clinicaltrials.gov/study/NCT07156773)

## Key Facts

- **Phase:** PHASE2
- **Status:** RECRUITING
- **Study Type:** INTERVENTIONAL
- **Sponsor:** Guangzhou Novaken Pharm Co., Ltd.
- **Target Enrollment:** 84 participants
- **Start Date:** 2025-09-03
- **Completion Date:** 2026-03-30
- **Conditions:** Parkinson Disease
- **Interventions:** XJN010 Nasal Spray, Placebo
- **Intervention Types:** DRUG

## Summary For Families

The trial is testing whether XJN010 nasal spray can safely and quickly reduce "off" episodes, the times when Parkinson's motor symptoms return between doses of levodopa. XJN010 is given as a nasal spray so the drug is absorbed rapidly through the nose to act fast during an off period, and it is being studied as an add-on rescue treatment alongside patients' usual levodopa rather than a replacement. Eligible participants are adults 30 to 85 years old with Parkinson's for at least three years, Hoehn‑Yahr stage 1 to 3 when "on," and who show clear levodopa responsiveness. People with prior PD surgery like DBS, major nasal problems, recent serious psychiatric illness or certain unstable medical or lab conditions, pregnant or breastfeeding people, and those on unstable CNS-active medications are excluded.

## Eligibility

- **Minimum age:** 30 Years
- **Maximum age:** 85 Years
- **Sex:** ALL

### Full Criteria

```
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.
```

## Locations (1)

- The First Affiliated Hospital of Jinan University (Guangzhou Overseas Chinese Hospital), Guangzhou, Guangdong, China _(23.1167, 113.2500)_
  - Wei Bi, PhD — (CONTACT) — +86+18028089705 — biwei4762@sina.com

## Central Contacts

- HuaLiang Liu, Master — (CONTACT) — +86+13590957282 — liuhl@gznovaken.com

---

*Canonical: https://parkinsonspathways.com/trial/NCT07156773*  
*HTML version: https://parkinsonspathways.com/trial/NCT07156773*  
*Source data: https://clinicaltrials.gov/study/NCT07156773*