Tenofovir Disoproxil Fumarate in the Treatment of Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06356662
• Other study ID #: KY-2023-198
• Status: Recruiting
• Phase: Phase 1
• Start date: January 23, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• Tenofovir Disoproxil Fumarate
take tenofovir disoproxil fumarate 300mg/d

Locations

Country	Name	City	State
China	Guohua Zhao	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	UPDRS III(Unified Parkinson's Disease Rating Scale part 3)	score:0-132,higher scores mean a worse outcome	1 month?3 month
Secondary	Non-Motor Symptom Scale(NMSS)	score:0-360,higher scores mean a worse outcome	1 month?3 month
Secondary	creatinine(µmoI/L)	blood biochemistry test,normal<97µmoI/L	1 month?3 month