Tenofovir Disoproxil Fumarate in the Treatment of Parkinson's Disease

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: Parkinson Disease
• Intervention / Treatment: Drug: Tenofovir Disoproxil Fumarate

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Guohua Zhao
      • Contact: Zhao Guohua, Doctor; Phone Number: +86 13777812308; Email: gzhao@zju.edu.cn

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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）	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）	score：0-360，higher scores mean a worse outcome	1 month、3 month
creatinine(μmoI/L)	blood biochemistry test，normal<97μmoI/L	1 month、3 month

Collaborators and Investigators

• Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2024
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): December 31, 2024

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): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 7, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Tenofovir
• 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