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

NCT ID: NCT07055958

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-29
• Study Completion Date: 2025-07-20

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Metformin- Patients receiving Levodopa with Metformin

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

Group Type: EXPERIMENTAL

Metformin

Intervention Type: 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.

Control - Patients receiving Levodopa with Placebo

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

placebo of tab. Metformin of same shape

Interventions

Metformin

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.

Intervention Type: DRUG

placebo

placebo of tab. Metformin of same shape

Intervention Type: OTHER

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

OTHER

Sponsor Role: lead

Responsible Party

RUKHSANA AKTER

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

BSMMU

Dhaka, , Bangladesh

Countries

Bangladesh

Other Identifiers

5246

Identifier Type: -

Identifier Source: org_study_id