NCT06356662

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1 parkinson-disease

Timeline
Completed

Started Jan 2024

Typical duration for phase_1 parkinson-disease

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 23, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 10, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 17, 2025

Status Verified

February 1, 2025

Enrollment Period

1.9 years

First QC Date

March 27, 2024

Last Update Submit

February 14, 2025

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

  • UPDRS III（Unified Parkinson's Disease Rating Scale part 3）

    score：0-132，higher scores mean a worse outcome

    1 month、3 month

Secondary Outcomes (2)

  • Non-Motor Symptom Scale（NMSS）

    1 month、3 month

  • creatinine(μmoI/L)

    1 month、3 month

Study Arms (2)

Tenofovir

EXPERIMENTAL

patients with parkinson's disease

Drug: Tenofovir Disoproxil Fumarate

Placebo

PLACEBO COMPARATOR

patients with parkinson's disease

Drug: Tenofovir Disoproxil Fumarate

Interventions

Tenofovir Disoproxil FumarateDRUG

take tenofovir disoproxil fumarate 300mg/d

PlaceboTenofovir

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • : essential tremor, stroke, epilepsy and other well-defined neurological disorders
  • : Or have received deep brain stimulation and other brain surgery
  • : Abnormal liver and kidney function
  • : Infected with chronic hepatitis B or AIDS (HIV-1 infection)
  • : Severe depression, schizophrenia, other psychiatric disorders or drug dependence
  • : Other serious physical diseases such as heart, lung, liver, kidney disease, blood disease and malignant tumor
  • : Pregnant or lactating women and seniors over 65 years of age
  • : Allergy or other contraindications to the investigational drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guohua Zhao

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Tenofovir

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2024

First Posted

April 10, 2024

Study Start

January 23, 2024

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

February 17, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)