Parkinsons Disease (PD)Phase 4MET-PDNCT07806019
Metformin in Parkinson's Disease: Safety and Efficacy
A Phase 4 study testing Metformin 500mg in people with Parkinsons Disease (PD), run by Jinnah Medical & Dental College.
Trial summary
This study will evaluate whether metformin when it will be given to patients with Parkinson's disease along with standard therapy (levodopa carbidopa) will improve motor symptoms and decreases levels of alpha synuclein and MDA in patients with PD as compare to PD patients receiving only standard therapy (levodopa… Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Parkinsons Disease (PD)
- What is being tested?
- Metformin 500mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 28 Aug 2026to 1 Feb 2027
- Phase
- Phase 4
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients diagnosed with primary PD age 50-70 years receiving levodopa + carbidopa. Diagnosis will be made in accordance with movement disorder society clinical diagnostic criteria for Parkinson's disease
Who cannot join
- Secondary Parkinsonism co-morbid (such as Diabetes mellitus, Cardio-vascular diseases, Senile tremors, Wilson's disease, Cancers etc.) Pregnant and lactating mothers Sensitivity to metformin Lactic acidosis History of alcohol use
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Efficacy and Safety Profile of Metformin in Parkinson's Disease
This study will evaluate whether metformin when it will be given to patients with Parkinson's disease along with standard therapy (levodopa carbidopa) will improve motor symptoms and decreases levels of alpha synuclein and MDA in patients with PD as compare to PD patients receiving only standard therapy (levodopa carbidopa)
- Conditions
- Parkinsons Disease (PD)
- Being tested
- Metformin 500mg
- Keywords
- Parkinson's disease, Neuroinflamation, Metformin, Alpha synuclein, MDA levels, MDS-UPDRS
- Medical subject headings
- Parkinson Disease, Parkinson Disease 4, Autosomal Dominant Lewy Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin 500mgDrug
Metformin will be given to the group B along with the standard treatment
| Study group | Role | What they receive |
|---|---|---|
| Group A (satndard treatment group) control group | No intervention | patients will continue standard therapy with carbidopa levodopa 250/25 mg TDS |
| Group B (Metformin group) | Active comparator | patients will receive 500mg Metformin BD for 12 weeks along with standard treatment with carbidopa levodopa 250/25mg TDS Receives: Drug: Metformin 500mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
MDS-UPDRS
Change in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score from baseline to 12 weeks to assess changes in Parkinson disease symptoms.
The MDS-UPDRS (Movement Disorder Society-Unified Parkinson's Disease Rating Scale) is the standard scale used to assess the severity and progression of Parkinson's disease (PD) and response to treatment.
It has 4 parts. Part I Non-motor experiences of daily living 52 Part II Motor experiences of daily living 52 Part III Motor examination performed by clinician 132 Part IV Motor complications of treatment, e.g., dyskinesia and fluctuations 24 Total score: 260
Each item is generally scored:
0 = Normal / no problem
- = Slight
- = Mild
- = Moderate
- = Severe Higher scores represents greater severity of Parkinson's disease.
Measured: 12weeks
MDA levels
Change in malondialdehyde (MDA) levels from baseline to 12 weeks to asses changes in oxidative stress
Measured: 12 weeks
Alpha Synuclein levels
Change in serum alpha-synuclein concentration from baseline to 12 weeks
Measured: 12 weeks
Secondary outcomes (4)
Safety profile of metformin
Safety profile of the interventional drug (metformin) will be assed in Group B (intervention group) 30 patients.
blood samples will be taken for blood (CBC) to check hemoglobin levels
Measured: From baseline to Week 12
Safety Profile of Metformin
Safety profile of the interventional drug (metformin) will be assed in Group B (intervention group) 30 patients. blood samples will be taken to assess the Renal side effects of drug by measuring Urea, creatinine, GFR
Measured: From baseline to week 12
Safety Profile of Metformin
Safety profile of the interventional drug (metformin) will be assed in Group B (intervention group) 30 patients. blood samples will be taken to assess the hepatic side effects of drug by measuring ALT,AST
Measured: Baseline to weeks 12
Safety Profile of Metformin
Safety profile of the interventional drug (metformin) will be assed in Group B (intervention group) 30 patients. blood samples will be taken to assess the Cardiac side effects of drug by measuring TGs, HDL
Measured: From baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start28 Aug 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinsons Disease (PD)Studies of the same condition, open and under way.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Model Description
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinnah Medical & Dental College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07806019
- Sponsor's protocol ID
- 00247/26
- Acronym
- MET-PD
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- 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 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy and Safety Profile of Metformin in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07806019
- Acronym / sponsor ID
- MET-PD / 00247/26
- Conditions
- Parkinsons Disease (PD)
- Keywords
- Parkinson's disease, Neuroinflamation, Metformin, Alpha synuclein, MDA levels, MDS-UPDRS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Jinnah Medical & Dental CollegeUniversity, hospital or other
- Study start
- 28 Aug 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 8 Sep 2026 (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.
This study will evaluate whether metformin when it will be given to patients with Parkinson's disease along with standard therapy (levodopa carbidopa) will improve motor symptoms and decreases levels of alpha synuclein and MDA in patients with PD as compare to PD patients receiving only standard therapy (levodopa carbidopa)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Model Description
| Arm | Type | Receives |
|---|---|---|
| Group A (satndard treatment group) control group | No intervention | –patients will continue standard therapy with carbidopa levodopa 250/25 mg TDS |
| Group B (Metformin group) | Active comparator | Drug: Metformin 500mgpatients will receive 500mg Metformin BD for 12 weeks along with standard treatment with carbidopa levodopa 250/25mg TDS |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male and female patients diagnosed with primary PD age 50-70 years receiving levodopa + carbidopa. Diagnosis will be made in accordance with movement disorder society clinical diagnostic criteria for Parkinson's disease
Key exclusion criteria (1 listed)
- Secondary Parkinsonism co-morbid (such as Diabetes mellitus, Cardio-vascular diseases, Senile tremors, Wilson's disease, Cancers etc.) Pregnant and lactating mothers Sensitivity to metformin Lactic acidosis History of alcohol use
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 |
|---|---|---|
| Metformin 500mgMetformin will be given to the group B along with the standard treatment | Drug | Group B (Metformin group) |
Primary outcome
MDS-UPDRS
Time frame: 12weeks
Change in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score from baseline to 12 weeks to assess changes in Parkinson disease symptoms. The MDS-UPDRS (Movement Disorder Society-Unified Parkinson's Disease Rating Scale) is the standard scale used to assess the severity and progression of Parkinson's disease (PD) and response to treatment. It has 4 parts. Part I Non-motor experiences of daily living 52 Part II Motor experiences of daily living 52 Part III Motor examination performed by clinician 132 Part IV Motor complications of treatment, e.g., dyskinesia and fluctuations 24 Total score: 260 Each item is generally scored: 0 = Normal / no problem 1. = Slight 2. = Mild 3. = Moderate 4. = Severe Higher scores represents greater severity of Parkinson's disease.
MDA levels
Time frame: 12 weeks
Change in malondialdehyde (MDA) levels from baseline to 12 weeks to asses changes in oxidative stress
Alpha Synuclein levels
Time frame: 12 weeks
Change in serum alpha-synuclein concentration from baseline to 12 weeks
4 secondary outcomes
Safety profile of metformin
Time frame: From baseline to Week 12
Safety Profile of Metformin
Time frame: From baseline to week 12
Safety Profile of Metformin
Time frame: Baseline to weeks 12
Safety Profile of Metformin
Time frame: From baseline to week 12
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 9 Sep 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metformin 500mg in people with Parkinsons Disease (PD), run by Jinnah Medical & Dental College.
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 1 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: opening soon, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Syeda Midhat Zaidi, MBBS (+923342434378, drmidhatzehra@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MDS-UPDRS (time frame: 12weeks). The study lists 3 primary outcomes in all. 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 9 Sep 2026.