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

Phase 2

Recruiting

• Conditions: Parkinson Disease
• Interventions: Drug: levodopa-carbidopa; Drug: Metformin

• Registration Number: NCT05781711
• Lead Sponsor: Tanta University

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-06
• Study First Submitted: 2023-03-11
• Study First Submitted QC: 2023-03-11
• Study First Posted: 2023-03-23
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-31
• Last Update Posted: 2025-01-03
• Primary Completion: 2025-09-20
• Study Completion: 2025-11-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin group	levodopa-carbidopa	Patients will receive levodopa/carbidopa (50/250 mg) three times daily plus metformin 500 mg two times daily for 3 months
Control Group	levodopa-carbidopa	Control group ( Levo-dopa group, n =30 ) who will receive levodopa/carbidopa (50/250 mg) three times daily for 3 months
Metformin group	Metformin	Patients will receive levodopa/carbidopa (50/250 mg) three times daily plus metformin 500 mg two times daily for 3 months

Primary Outcome Measures

Name	Time	Method
• The primary endpoint is the change in The Unified Parkinson's Disease Rating Scale (UPDRS)	3 months	• The primary endpoint is the change in the Unified Parkinson's Disease Rating Scale (UPDRS

Secondary Outcome Measures

Name	Time	Method
The secondary endpoint is estimated by changes in serum biomarkers.	3 months	The secondary endpoint is estimated by changes in serum biomarkers such as brain derived neurotropic factor

Trial Locations

Locations (1)

Faculty of Medicine, Menoufia University; 🇪🇬 Tanta, Shebeen El-Kom, Egypt