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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05781711
• Other study ID #: 3-2023
• Status: Recruiting
• Phase: Phase 2
• Start date: January 6, 2023
• Est. completion date: November 20, 2025

Study information

• Verified date: April 2024
• Source: Tanta University
• Contact: Mostafa M Bahaa, PhD
• Phone: 0201025538337
• Email: mbahaa[@]horus.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 20, 2025
• Est. primary completion date: September 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Menoufia University	Tanta	Shebeen El-Kom

Sponsors (4)

Lead Sponsor	Collaborator
Tanta University	Eman Ibrahim Elberri, Faculty of Pharmacy, Tanta University, Fedaa Abd El-monem Kamal El-deen Kotkata Faculty of Pharmacy, Tanta University, Manal Ali Mahrous Hamouda Faculty of Pharmacy, Menufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• The primary endpoint is the change in The Unified Parkinson's Disease Rating Scale (UPDRS)	• The primary endpoint is the change in the Unified Parkinson's Disease Rating Scale (UPDRS	3 months
Secondary	The secondary endpoint is estimated by changes in serum biomarkers.	The secondary endpoint is estimated by changes in serum biomarkers such as brain derived neurotropic factor	3 months