Can a new pill slow Parkinson's symptoms?
NCT ID NCT07741045
First seen Aug 03, 2026 · Last updated Aug 13, 2026 · Updated 3 times
Summary
This clinical trial is testing an experimental medication called TJ0113 in people with early-onset Parkinson's disease. The study aims to see if TJ0113 can improve movement symptoms compared to a placebo. About 300 participants will take either TJ0113 or a placebo for 26 weeks, followed by an open-label period where everyone receives TJ0113. The main goal is to measure changes in motor symptoms using a standard Parkinson's rating scale.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TJ0113 capsules
- What this could lead to
- If effective, TJ0113 could offer a new treatment option to help control movement symptoms in people with early-onset Parkinson's disease.
- What could go wrong
- This is an early-stage test in a specific group, and results may not apply to all Parkinson's patients. The drug's safety and effectiveness are not yet proven.
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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Aug 2026
An estimate. Start dates often move.
- Expected to finish
-
Nov 2028
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
-
18 to 80 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: 1. Participants who voluntarily participate in the clinical trial, and have signed the ICF, are able to understand and follow the study protocol, willing to visit the study site on time, fully understand the content, process and potential adverse reactions of the study, and indicate the date of signing the ICF; 2. Male or female aged 18 to 80 years (inclusive) at the time of signing the ICF; 3. Meets the 2015 International Parkinson and Movement Disorder Society (MDS) diagnostic criteria for primary PD\[1\] or the 2016 Chinese diagnostic criteria for Parkinson's disease\[13\]; with an age of onset ≤50 years, diagnosed as EOPD; 4. Able to cooperate in completing the "off" time records in the diary card; 5. Modified Hoehn-Yahr stage 1\~2.5 (inclusive) in the "off" state at screening; 6. Has been stably receiving anti-PD treatment before baseline and agrees to keep the original anti-PD medication unchanged during the trial; at the time of randomization, the investigator judges that the current treatment regimen has achieved optimal disease management status; \- "Stably receiving anti-PD treatment" is defined as: 1) Must use levodopa, may be combined with other anti-PD medications; 2) The type and name of anti-PD medications used by the participant have remained unchanged for at least 3 months prior to the baseline visit, and the dose has remained unchanged for at least 1 month prior to the baseline visit; 3) In this trial: No planned dose regimen adjustments during the double-blind treatment period; changes to the dose of stably received anti-PD medications are discouraged during the open-label treatment period, but if necessary, the dose may be adjusted at the discretion of the investigator. 7. MDS-UPDRS Part III score ≥22 in off-anti-PD medication state at screening; 8. Participants of childbearing potential (including spouses of male participants) who have no childbearing or sperm donation plan from the end of the screening period to within 6 months after the last dose and are willing to use at least one effective method (see Appendix I for details) for contraception. Exclusion Criteria: 1. Presence of any medical condition that may interfere with full participation in the study, including but not limited to the following: medical history of epilepsy or any complications, medical history of hemolytic anemia, pulmonary embolism, respiratory depression, active psychiatric disease, or malignancy; positive tumor marker detection results at screening and judged by the investigator to be clinically significant; 2. Participants who have experienced a New York Heart Association (NYHA) Class III or above congestive heart failure, unstable angina pectoris, acute myocardial infarction, hemorrhagic stroke, and ischemic stroke (including transient ischemic attack) within 6 months before screening; or those who have undergone any percutaneous coronary intervention or coronary artery bypass grafting, heart valve repair/replacement; or those with severe arrhythmia as judged by the investigator at the time of screening; 3. A personal or family history of long QT syndrome, a family history of sudden death in first-degree relatives (parents, offspring, and siblings) before the age of 40; and/or a personal history of unexplained syncope within 1 year prior to screening; and/or QTcF \>450 ms (male) or QTcF \>470 ms (female) based on resting ECG results at screening; 4. Participants with unstably controlled hypertension at screening, defined as the systolic blood pressure ≥ 160 mmHg and/or the diastolic blood pressure ≥ 100 mmHg (verify before randomization); 5. Participants with symptomatic orthostatic hypotension at screening, or who experiences a decrease in systolic blood pressure of ≥ 30 mmHg or a decrease in diastolic blood pressure of ≥ 15 mmHg within 3 minutes when changing from the supine to the standing position (verify before randomization); 6. Atypical parkinsonian syndromes (such as multiple system atrophy, progressive supranuclear palsy, etc.), or secondary parkinsonism with clearly identified causes such as drug-induced, vascular, toxic, metabolic, infectious, or traumatic brain injury; 7. Participants who have clinically significant hepatic insufficiency which is defined as the total bilirubin (TBIL) \> 2 × upper limit of normal (ULN) or alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \> 2 × ULN; 8. Participants with clinically significant renal insufficiency (creatinine clearance \[Ccr\] \<30 mL/min, see Appendix 2 calculation formula); 9. Any condition (e.g., severe arthritis, severe dyskinesia, traumatic injury with permanent physical disability) that may affect the MDS-UPDRS motor examination; 10. Participants who have a history of suicidal intention (including actual attempts, interrupted attempts, or failed attempts) and are at risk of committing suicide as judged by the investigator; 11. Participants judged by the investigator to have severe psychiatric abnormalities (anxiety, depression), with a single item score ≥3 for item 1.3 (Depression) or item 1.4 (Anxiety) in Part 1 of the MDS-UPDRS at screening; 12. Participants who have taken any serotonin reuptake inhibitors (such as fluoxetine, paroxetine, trazodone, citalopram, escitalopram, etc.) within 4 weeks prior to screening; 13. Use of anticholinergics or amantadine for PD treatment within 3 months prior to screening, or requiring stable use of anticholinergics or amantadine for PD treatment during the trial; 14. Participants who have dementia or moderate or above cognitive dysfunction and the MDS-UPDRS score for 1.1 cognitive impairment is ≥ 3 at screening; 15. Participants who have a history of surgical treatment for PD (e.g., deep brain stimulation, pallidotomy, etc.), or those who have undergone any major or medium surgery or have experienced any serious trauma or serious infection within 3 months prior to screening, those who are unsuitable for this study at the discretion of the investigator or plan to undergo any surgical treatment (excluding an outpatient surgery that has no impact on participant safety or study results as judged by the investigator) during the study; 16. Participants who have participated in a clinical trial that involves the administration of an investigational drug (a new chemical entity), device, or surgery within 3 months or 5 half-lives before screening, whichever is longer; 17. Evidence of alcohol abuse (average weekly consumption of ≥14 units of alcohol, where 1 unit ≈ 360 mL of beer, 45 mL of spirits, or 150 mL of wine) or drug abuse within 6 months prior to screening, which in the investigator's opinion would interfere with the participant's understanding or completion of the trial; 18. Participants who are known to have hypersensitivity/allergic reaction or intolerance to any component of the investigational product; 19. Positive for Hepatitis B surface antigen (HBsAg) or positive for Hepatitis B core antibody (HBcAb) with Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) above the upper limit of detection, or positive for Hepatitis C Virus (HCV) antibody, or positive for Human Immunodeficiency Virus (HIV) antibody, or positive for Treponema pallidum antibody at screening; 20. Pregnant or breastfeeding women; 21. Participants who are unable to swallow oral drugs, or have any condition that may significantly affect the absorption, distribution, metabolism and excretion of the drug, or any condition that may pose a hazard to participants participating in the study, as judged by the investigator; 22. Participants who have a history of organ transplantation (excluding corneal transplantation); 23. Participants who have donated or lost blood of ≥400 mL, or received blood transfusions within 3 months prior to screening; Participants who have any other conditions that may affect study compliance as deemed by the investigator, or those who are unable to participate in the study for their own reasons.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Early onset 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
21 sites. 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
-
Beijing Hospital
Beijing, Beijing Municipality, China
-
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
-
General Hospital of Nuclear Industry (The Second Affiliated Hospital of Soochow University)
Suzhou, Jiangsu, China
-
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
-
Henan Provincial People's Hospital
Zhengzhou, Henan, China
-
Huzhou Central Hospital
Huzhou, Zhejiang, China
-
Jiaxing Second Hospital
Jiaxing, Zhejiang, China
-
Lishui Municipal People's Hospital
Lishui, Zhejiang, China
-
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
-
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
-
Taizhou Central Hospital
Taizhou, Zhejiang, China
-
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
-
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, Zhejiang, China
-
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
-
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
-
The Third Xiangya Hospital, Central South University
Changsha, Hunan, China
-
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
-
Wenzhou Central Hospital
Wenzhou, Zhejiang, China
-
West China Hospital, Sichuan University
Chengdu, Sichuan, China
-
Xiangya Hospital, Central South University
Changsha, Hunan, China
-
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can brain stimulation be tuned to improve sleep in Parkinson's?
- Can a blood bank unlock the genetics of brain disease?
- Sleep disorder may hold the key to spotting Parkinson's years earlier
- Can a gentle brain zapping schedule ease Parkinson's symptoms?
- Dancing away Parkinson's symptoms: tango therapy put to the test
- Gentle bowing, calmer mind: music therapy put to the test for Parkinson's anxiety