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Active, Not Recruiting

NCT Number: NCT07055958

Effect of Metformin as Add-on Therapy in Levodopa Treated Parkinson's Disease Patients

The goal of this clinical trial is to learn that metformin has effect on motor aspects of daily living and oxidative stress in levodopa treated Parkinson disease patients. Researcher will compare drug metformin to a placebo. Participants will take metformin or placebo for 8 weeks.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

BSMMU

Dhaka, 1217, Bangladesh

About this study

This clinical trial is an effort to explore whether administration of metformin has effect on motor aspects of daily living and oxidative stress in levodopa treated Parkinson's disease patients. After completion of necessary formalities, each participant will be assessed by translated and validated Bangla version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part questionnaire and malondialdehyde (MDA) and glutathione (GSH) will be measured at baseline and after 8 weeks.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed mild to moderate PD patients taking Levodopa
  • Age 18 years and older
  • Sex : Any

Exclusion criteria

  • Secondary causes of Parkinsonism
  • Prior stereotactic surgery for PD
  • Suffering from active malignancy
  • Known hypersensitivity to metformin
  • Pregnancy or lactation

Treatment and study plan

metformin

Drug

Metformin's chemical name is 1,1-Dimethylbiguanide, a molecular formula of C4H11N5. Beyond its well established antihyperglycemic impact, metformin demonstrated anti-oxidant and anti-inflammatory activities contributing its potential benefits in conditions associated with inflammation and oxidative stress. Furthermore, metformin rapidly crosses the blood brain barrier and disperses into several brain regions presenting an ideal therapeutic option for the treatment of PD.

Placebo

Other

placebo of tab. Metformin of same shape

Primary outcomes

  1. motor aspects of daily living

    Time frame: 8 weeks

    motor aspects of daily living in MDS-UPDRS rating scale (Movement Disorder Society- sponsored revision of the Unified Parkinson's Disease Rating Scale). The score of Part 2 of this scale i.e. motor experiences of daily living is 13.

Secondary outcomes

  1. 1. Plasma Malondealdehyde (MDA) level in micromole/litre. 2. Erythrocyte Glutathione (GSH) level in mg/ml.

    Time frame: 8 weeks

    Malondealdehyde is oxidative stress marker. Glutathione is anti-oxidant.

  2. 1. Erythrocyte glutathione level in mg/ml 2. Erythrocyte Glutathione (GSH) level in mg/ml.

    Time frame: 8 weeks

    Glutathione is an anti-oxidant Glutathione is anti-oxidant.

  3. Comparison of adverse effects in percentage

    Time frame: 8 weeks

    Adverse effects in Metformin treated and placebo treated patients

Sponsors and collaborators

Lead sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Other

Registry information

Official study title

Effect of Metformin as Add-on Therapy in Levodopa Treated Parkinson's Disease Patients: Randomized, Double Blind, Placebo Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 9, 2025
Registry last updated
Jul 9, 2025

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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