Tenofovir Disoproxil Fumarate in the Treatment of Parkins... | NCT06356662

Studies
Tenofovir Disoproxil Fumarate in the Treatment of Parkinson's Disease

NCT06356662

Sponsor

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Status

Recruiting

Last Update Posted

Feb 17, 2025Actual

Enrollment

60Estimated

Phase

Phase 1

Conditions

Parkinson Disease

Interventions

Tenofovir Disoproxil Fumarate

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 23, 2024Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Mar 27, 2024

First Submission Date that Met QC Criteria

Apr 7, 2024

First Posted Date

Apr 10, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2025

Last Update Posted Date

Feb 17, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tenofovir	Experimental	patients with parkinson's disease	Drug: Tenofovir Disoproxil Fumarate
Placebo	Placebo Comparator	patients with parkinson's disease	Drug: Tenofovir Disoproxil Fumarate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tenofovir Disoproxil Fumarate	Drug	take tenofovir disoproxil fumarate 300mg/d	Placebo Tenofovir

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Guohua Zhao	Recruiting	Hangzhou	Zhejiang		China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068698	Tenofovir

Ancestor Terms

ID	Term
D063065	Organophosphonates
D009943	Organophosphorus Compounds
D009930	Organic Chemicals
D000225	Adenine

Browse Leaves

Not provided

Browse Branches

Not provided