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NCT Number: NCT06356662

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tenofovir disoproxil fumarate

Drug

take tenofovir disoproxil fumarate 300mg/d

Primary outcomes

  1. 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

Secondary outcomes

  1. Non-Motor Symptom Scale（NMSS）

    Time frame: 1 month、3 month

    score：0-360，higher scores mean a worse outcome

  2. creatinine(μmoI/L)

    Time frame: 1 month、3 month

    blood biochemistry test，normal<97μmoI/L

Sponsors and collaborators

Lead sponsor

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 10, 2024
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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