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Not yet recruitingNCT07806019MET-PDUpdated Sep 9, 2026

Metformin in Parkinson's Disease: Safety and Efficacy

A Phase 4 interventional study of Metformin 500mg in Parkinsons Disease (PD), sponsored by Jinnah Medical & Dental College. Not yet recruiting. Open to participants aged 50 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Jinnah Medical & Dental College · Phase 4, Interventional, and Supportive care

Phase
Phase 4
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
50 Years to 70 Years
Sex
All
01

Study 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 carbidopa)

02

Conditions studied

  • Parkinsons Disease (PD)

Keywords

  • Parkinson's disease
  • Neuroinflamation
  • Metformin
  • Alpha synuclein
  • MDA levels
  • MDS-UPDRS
03

Who can participate

Ages eligible
50 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria: :

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

Exclusion Criteria:

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

04

Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • No intervention
    Group A (satndard treatment group) control group

    patients will continue standard therapy with carbidopa levodopa 250/25 mg TDS

  • Active comparator
    Group B (Metformin group)

    patients will receive 500mg Metformin BD for 12 weeks along with standard treatment with carbidopa levodopa 250/25mg TDS

    Drug: Metformin 500mg

Interventions

  • DrugMetformin 500mg

    Metformin will be given to the group B along with the standard treatment

05

What researchers measure

Primary outcomes

  1. 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 1. = Slight 2. = Mild 3. = Moderate 4. = Severe Higher scores represents greater severity of Parkinson's disease.

    Time frame: 12weeks

  2. MDA levels

    Change in malondialdehyde (MDA) levels from baseline to 12 weeks to asses changes in oxidative stress

    Time frame: 12 weeks

  3. Alpha Synuclein levels

    Change in serum alpha-synuclein concentration from baseline to 12 weeks

    Time frame: 12 weeks

Secondary outcomes

  1. 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

    Time frame: From baseline to Week 12

  2. 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

    Time frame: From baseline to week 12

  3. 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

    Time frame: Baseline to weeks 12

  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 to assess the Cardiac side effects of drug by measuring TGs, HDL

    Time frame: From baseline to week 12

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07806019
Lead sponsor
Jinnah Medical & Dental College
Responsible party
Sponsor
First posted
Sep 8, 2026
Start date
Aug 28, 2026 (estimated)
Primary completion
Feb 1, 2027 (estimated)
Completion
Feb 1, 2027 (estimated)
Last update
Sep 9, 2026

Study contacts

Syeda Midhat Zaidi, MBBS
Contact
drmidhatzehra@gmail.com
+923342434378
Nasim Karim, MBBS, MPhil, PhD, Post-doc
Contact
nsm_karim@yahoo.com
+923323151774

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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