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

Not Applicable

Active, not recruiting

• Conditions: Parkinson Disease
• Interventions: Drug: Metformin; Other: placebo

• Registration Number: NCT07055958
• Lead Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2024-12-29
• Study First Submitted: 2025-05-30
• Primary Completion: 2025-06-30
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-04
• Last Update Submitted: 2025-07-04
• Study First Posted: 2025-07-09
• Last Update Posted: 2025-07-09
• Study Completion: 2025-07-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin- Patients receiving Levodopa with Metformin	Metformin	Dosage form- Tab. Metformin 500 mg, Frequency - once daily, Duration - 8 weeks
Control - Patients receiving Levodopa with Placebo	placebo	placebo of Tab. Metformin 500 mg, frequency- once daily, duration- 8 weeks

Primary Outcome Measures

Name	Time	Method
motor aspects of daily living	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 Outcome Measures

Name	Time	Method
1. Erythrocyte glutathione level in mg/ml 2. Erythrocyte Glutathione (GSH) level in mg/ml.	8 weeks	Glutathione is an anti-oxidant Glutathione is anti-oxidant.
Comparison of adverse effects in percentage	8 weeks	Adverse effects in Metformin treated and placebo treated patients
1. Plasma Malondealdehyde (MDA) level in micromole/litre. 2. Erythrocyte Glutathione (GSH) level in mg/ml.	8 weeks	Malondealdehyde is oxidative stress marker. Glutathione is anti-oxidant.

Trial Locations

Locations (1)

BSMMU; 🇧🇩 Dhaka, Bangladesh