Tenofovir Disoproxil Fumarate in the Treatment of Parkinson's Disease

February 14, 2025 updated by: The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Efficacy and Safety of Tenofovir Disoproxil Fumarate in the Treatment of Parkinson's Disease

To evaluate the efficacy and safety of tenofovir disoproxil fumarate in the treatment of Parkinson's disease. The changes of motor symptoms and the occurrence of adverse reactions in early Parkinson's disease patients who took tenofovir disoproxil fumarate and did not take Tenofovir disoproxil fumarate at different time points were compared.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Guohua Zhao
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1: Parkinson's disease: Hoehn Yahr= 1 to 2.5 2: MMSE score≥24

Exclusion Criteria:

  • 1: essential tremor, stroke, epilepsy and other well-defined neurological disorders

    2: Or have received deep brain stimulation and other brain surgery

    3: Abnormal liver and kidney function

    4: Infected with chronic hepatitis B or AIDS (HIV-1 infection)

    5: Severe depression, schizophrenia, other psychiatric disorders or drug dependence

    6: Other serious physical diseases such as heart, lung, liver, kidney disease, blood disease and malignant tumor

    7: Pregnant or lactating women and seniors over 65 years of age

    8: Allergy or other contraindications to the investigational drug

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tenofovir
patients with parkinson's disease
Drug: Tenofovir Disoproxil Fumarate
take tenofovir disoproxil fumarate 300mg/d
Placebo Comparator: Placebo
patients with parkinson's disease
Drug: Tenofovir Disoproxil Fumarate
take tenofovir disoproxil fumarate 300mg/d

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
UPDRS III（Unified Parkinson's Disease Rating Scale part 3）
Time Frame: 1 month、3 month
score：0-132，higher scores mean a worse outcome
1 month、3 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-Motor Symptom Scale（NMSS）
Time Frame: 1 month、3 month
score：0-360，higher scores mean a worse outcome
1 month、3 month
creatinine(μmoI/L)
Time Frame: 1 month、3 month
blood biochemistry test，normal<97μmoI/L
1 month、3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

March 27, 2024

First Submitted That Met QC Criteria

April 7, 2024

First Posted (Actual)

April 10, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 14, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY-2023-198

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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