Efficacy and Safety of TJ0113 Capsule in Patients With Parkinson's Disease

NCT06596005 | Completed Phase 2 Results

• 1 other identifier: TJJS01-201
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, double-blind, placebo parallel-controlled Phase II clinical trial to evaluate the efficacy and safety of TJ0113 capsule in patients with early-stage Parkinson's disease

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Changes From Baseline in Scores of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Motor Examination) in Subjects After 12 Weeks of Treatment.Evaluation Time Point: ≥ 12 Hours From the Most Recent Dose of Anti-PD Drug.

  The Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) rating tool was used to follow longitudinal course of Parkinson's Disease. It was made up of 4 parts. In this study, the Part III score was designated as the primary efficacy endpoint.Part 3: Motor examination (18 items, some of which include multiple scorable components, resulting in a total of 33 scoreable entries, with an overall score ranging from 0 to 132).Higher values represent a worse outcome.

  After 12 weeks.

Study Arms (3)

TJ0113 200mg

EXPERIMENTAL

Subjects will receive 200 mg of TJ0113 capsules for 12 consecutive weeks

Drug: TJ0113 200mg

TJ0113 400mg

EXPERIMENTAL

Subjects will receive 400 mg of TJ0113 capsules for 12 consecutive weeks

Drug: TJ0113 400mg

Placebo

PLACEBO COMPARATOR

Subjects will receive 200 mg or 400 mg of placebo for 12 consecutive weeks

Drug: Placebo

Interventions

TJ0113 200mg DRUG

200 mg Capsule, Once Daily

TJ0113 200mg

TJ0113 400mg DRUG

400 mg Capsule, Once Daily

TJ0113 400mg

Placebo DRUG

Capsule, Once Daily

Placebo

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who voluntarily participate in the clinical trial, and have signed the informed consent form (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;
• Males or females aged 30-80 years (both inclusive) at the time of signing the ICF;
• Subjects who are diagnosed with PD according to the Diagnostic Criteria for Parkinson's Disease in China (2016 edition);
• The scores of modified Hoehn and Yahr Scale at screening are 1-2.5 (both inclusive);
• Subjects who have not previously received anti-PD drugs; or those who have previously used any anti-PD drugs but have not received such drug within 4 weeks before study entry; or those who have received the anti-PD drug at a stable dose for at least 4 weeks before study entry and agree to maintain the original treatment regimen during the study;
• Subjects with the scores of MDS-UPDRS Part III of ≥ 22 at screening (it should be scored ≥ 12 hours apart from the most recent dose of the anti-PD drug for subjects who have been receiving an anti-PD drug at a stable dose for at least 4 weeks prior to study entry);
• Subjects of childbearing potential (including spouses of male subjects) 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.

You may not qualify if:

• 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;
• Subjects who have experienced a New York Heart Association (NYHA) Class III or above congestive heart failure, unstable angina pectoris, acute myocardial infarction, hemorrhagic stroke (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;
• Subjects with prior personal or family history of long-QT syndrome, family history of sudden death of any immediate family members (meaning a parent, child, or sibling) prior to the age of 40 years; and/or personal history of unexplained syncope within 1 year prior to screening; and/or QTcF \> 450 ms (male), QTcF \> 470 ms (female) measured by Electrocardiogram(ECG) at rest during screening;
• Subjects 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);
• Subjects 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);
• Atypical PD (e.g., Parkinsonism, multiple system atrophy, progressive supranuclear palsy), or secondary PD (e.g., delayed or drug-induced PD);
• Subjects 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;
• Subjects who have clinically significant renal insufficiency (creatinine clearance \[Ccr\] \< 30 mL/min, see the calculation formula in Appendix II);
• Any condition (e.g., severe arthritis, severe dyskinesia, traumatic injury with permanent physical disability) that may affect the MDS-UPDRS motor examination;
• Subjects 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;
• Subjects who suffer from severe mental abnormalities (anxiety, depression) as judged by the investigator, and the depression or anxiety score as rated by the Part I of the MDS-UPDRS is ≥ 3 at screening;
• Subjects who have taken any serotonin reuptake inhibitors (such as fluoxetine, paroxetine, trazodone, citalopram, escitalopram, etc.) within 4 weeks prior to screening;
• Subjects who have dementia or moderate or above cognitive dysfunction and the MDS-UPDRS score for 1.1 cognitive impairment is ≥ 3 at screening;
• Subjects 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 subject safety or study results as judged by the investigator) during the study;
• Subjects 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;

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Taizhou Hospital: collaborator
• Wenzhou Central Hospital: collaborator
• Sir Run Run Shaw Hospital: collaborator
• The Second Affiliated Hospital of Jiaxing University: collaborator
• Hangzhou PhecdaMed Co., Ltd.: collaborator
• Huzhou Central Hospital: collaborator
• Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University: collaborator

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Hangzhou PhecdaMed Co., Ltd.

dong.liu@phecdamed.com

+86 18626868383

Study Officials

• Wei Luo, Doctor

  Sceond Affiliated Hospital, School of Medicine, Zhejiang University, China

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: September 18, 2024
• Primary Completion: September 3, 2025
• Study Completion: September 9, 2025
• Last Updated: January 16, 2026
• Results First Posted: January 16, 2026

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)