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NCT Number: NCT07806019

Metformin in Parkinson's Disease: Safety and Efficacy

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)

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Key information

Conditions

Parkinsons Disease (PD) Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinson Disease 4, Autosomal Dominant Lewy Body Parkinsonian Disorders Synucleinopathies

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metformin 500mg

Drug

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

Primary outcomes

  1. 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

    • = Slight
    • = Mild
    • = Moderate
    • = Severe Higher scores represents greater severity of Parkinson's disease.

  2. MDA levels

    Time frame: 12 weeks

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

  3. Alpha Synuclein levels

    Time frame: 12 weeks

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

Secondary outcomes

  1. Safety profile of metformin

    Time frame: From baseline to Week 12

    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

  2. Safety Profile of Metformin

    Time frame: From baseline to week 12

    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

  3. Safety Profile of Metformin

    Time frame: Baseline to weeks 12

    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

  4. Safety Profile of Metformin

    Time frame: From baseline to week 12

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Nasim Karim, MBBS, MPhil, PhD, Post-doc

CONTACT

[email protected]

+923323151774

Syeda Midhat Zaidi, MBBS

CONTACT

[email protected]

+923342434378

Sponsors and collaborators

Lead sponsor

Jinnah Medical & Dental College

Other

Registry information

Official study title

Clinical Efficacy and Safety Profile of Metformin in Parkinson's Disease

Acronym: MET-PD

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 8, 2026
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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