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

NCT07055958 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: 5246
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Metformin, Parkinson disease

Outcome Measures

Primary Outcomes (1)

• motor aspects of daily living

  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.

  8 weeks

Secondary Outcomes (3)

• 1. Plasma Malondealdehyde (MDA) level in micromole/litre. 2. Erythrocyte Glutathione (GSH) level in mg/ml.

  8 weeks

• 1. Erythrocyte glutathione level in mg/ml 2. Erythrocyte Glutathione (GSH) level in mg/ml.

  8 weeks

• Comparison of adverse effects in percentage

  8 weeks

Study Arms (2)

Metformin- Patients receiving Levodopa with Metformin

EXPERIMENTAL

Dosage form- Tab. Metformin 500 mg, Frequency - once daily, Duration - 8 weeks

Drug: Metformin

Control - Patients receiving Levodopa with Placebo

PLACEBO COMPARATOR

placebo of Tab. Metformin 500 mg, frequency- once daily, duration- 8 weeks

Other: placebo

Interventions

Metformin DRUG

Metformin's chemical name is 1,1-Dimethylbiguanide, a molecular formula of C4H11N5. Beyond its well established antihyperglycemic impact, metformin demonstrated anti-oxidant and anti-inflammatory activities contributing its potential benefits in conditions associated with inflammation and oxidative stress. Furthermore, metformin rapidly crosses the blood brain barrier and disperses into several brain regions presenting an ideal therapeutic option for the treatment of PD.

Metformin- Patients receiving Levodopa with Metformin

placebo OTHER

placebo of tab. Metformin of same shape

Control - Patients receiving Levodopa with Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed mild to moderate PD patients taking Levodopa
• Age 18 years and older
• Sex : Any

You may not qualify if:

• Secondary causes of Parkinsonism
• Prior stereotactic surgery for PD
• Suffering from active malignancy
• Known hypersensitivity to metformin
• Pregnancy or lactation

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

BSMMU

Dhaka, 1217, Bangladesh

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Metformin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: July 9, 2025
• Study Start: December 29, 2024
• Primary Completion: June 30, 2025
• Study Completion: July 20, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-07

Locations

BA (1)