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

March 12, 2026 updated by: Mostafa Bahaa, Tanta University
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Shebeen El-Kom
      • Tanta, Shebeen El-Kom, Egypt, 32511
        • Faculty of medicine, Menoufia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 6 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control Group
Control group ( Levo-dopa group, n =30 ) who will receive levodopa/carbidopa (50/250 mg) three times daily for 3 months
Drug: levodopa-carbidopa
levodopa-carbidopa is the standard therapy used in Parkinson's disease
Active Comparator: Metformin group
Patients will receive levodopa/carbidopa (50/250 mg) three times daily plus metformin 500 mg two times daily for 3 months
Drug: levodopa-carbidopa
levodopa-carbidopa is the standard therapy used in Parkinson's disease
Drug: Metformin
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
• 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
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Collaborators

Manal Ali Mahrous Hamouda Faculty of Pharmacy, Menufia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2023

Primary Completion (Actual)

January 20, 2025

Study Completion (Actual)

January 20, 2025

Study Registration Dates

First Submitted

March 11, 2023

First Submitted That Met QC Criteria

March 11, 2023

First Posted (Actual)

March 23, 2023

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3-2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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