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Completed

NCT Number: NCT05781711

Clinical Study to Evaluate the Possible Efficacy of Metformin in Patients With Parkinson's Disease

Parkinson's disease (PD) is one of the most common neurodegenerative diseases characterized by the progressive loss of dopaminergic (DA) neurons in the substantia nigra compacta (SNc) and aggregation of Lewy bodies in neurons. Although aging, oxidative damage and neuroinflammation have been recognized to play crucial roles in the pathogenesis of PD, the precise etiology remains obscure. Emerging evidence suggests PD is a systemic metabolic disease, and metabolic abnormality correlates with functional alternations in PD

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Medicine, Menoufia University

Tanta, Shebeen El-Kom, 32511, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Age ≥ 18 years Both males and females will be included Negative pregnancy test and effective contraception. Diagnosed Parkinson's disease patient taking Levodopa

Exclusion criteria

Secondary causes of Parkinsonism Diabetic patients Patients taking anti-inflammatory drugs Atypical parkinsonian syndromes Prior stereotaxic surgery for Parkinson's disease Pregnancy and lactation Suffering from active malignancy Addiction to alcohol and/or drugs Known allergy to the studied medications

Treatment and study plan

Levodopa-Carbidopa

Drug

levodopa-carbidopa is the standard therapy used in Parkinson's disease

metformin

Drug

Metformin, a biguanide family member commonly used in treatment for type 2 diabetes, appears to increase liver and peripheral tissue sensitivity to insulin as well as reduce hepatic glucose production

Primary outcomes

  1. • The primary endpoint is the change in The Unified Parkinson's Disease Rating Scale (UPDRS)

    Time frame: 3 months

    • The primary endpoint is the change in the Unified Parkinson's Disease Rating Scale (UPDRS

Secondary outcomes

  1. The secondary endpoint is estimated by changes in serum biomarkers.

    Time frame: 3 months

    The secondary endpoint is estimated by changes in serum biomarkers such as brain derived neurotropic factor

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Collaborators

  • Manal Ali Mahrous Hamouda Faculty of Pharmacy, Menufia University

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 23, 2023
Registry last updated
Mar 13, 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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