Parkinson DiseasePhase 1NCT06356662
Tenofovir Disoproxil Fumarate in the Treatment of Parkinson's Disease
A Phase 1 study testing Tenofovir Disoproxil Fumarate in people with Parkinson Disease, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Tenofovir Disoproxil Fumarate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 23 Jan 2024to 31 Dec 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1: Parkinson's disease: Hoehn Yahr= 1 to 2.5 2: MMSE score≥24
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guohua Zhao
Hangzhou, Zhejiang
Zhao Guohua, Doctor, +86 13777812308, gzhao@zju.edu.cn
About this study
Official title: 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.
- Conditions
- Parkinson Disease
- Being tested
- Tenofovir Disoproxil Fumarate
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir Disoproxil FumarateDrug
take tenofovir disoproxil fumarate 300mg/d
| Study group | Role | What they receive |
|---|---|---|
| Tenofovir | Experimental | patients with parkinson's disease Receives: Drug: Tenofovir Disoproxil Fumarate |
| Placebo | Placebo comparator | patients with parkinson's disease Receives: Drug: Tenofovir Disoproxil Fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
UPDRS III（Unified Parkinson's Disease Rating Scale part 3）
score：0-132，higher scores mean a worse outcome
Measured: 1 month、3 month
Secondary outcomes (2)
Non-Motor Symptom Scale（NMSS）
score：0-360，higher scores mean a worse outcome
Measured: 1 month、3 month
creatinine(μmoI/L)
blood biochemistry test，normal<97μmoI/L
Measured: 1 month、3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start23 Jan 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by The Fourth Affiliated Hospital of Zhejiang University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06356662
- Sponsor's protocol ID
- KY-2023-198
- Status last verified
- Feb 2025
- First submitted
- 27 Mar 2024
- Last updated
- 17 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Tenofovir Disoproxil Fumarate in the Treatment of Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06356662
- Acronym / sponsor ID
- KY-2023-198
- Conditions
- Parkinson Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 23 Jan 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tenofovir | Experimental | Drug: Tenofovir Disoproxil Fumaratepatients with parkinson's disease |
| Placebo | Placebo comparator | Drug: Tenofovir Disoproxil Fumaratepatients with parkinson's disease |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1: Parkinson's disease: Hoehn Yahr= 1 to 2.5 2: MMSE score≥24
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tenofovir Disoproxil Fumaratetake tenofovir disoproxil fumarate 300mg/d | Drug | Placebo, Tenofovir |
Primary outcome
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
2 secondary outcomes
Non-Motor Symptom Scale（NMSS）
Time frame: 1 month、3 month
creatinine(μmoI/L)
Time frame: 1 month、3 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tenofovir Disoproxil Fumarate in people with Parkinson Disease, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UPDRS III（Unified Parkinson's Disease Rating Scale part 3） (time frame: 1 month、3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.