Parkinson DiseasePhase 3NCT07055958
Effect of Metformin as Add-on Therapy in Levodopa Treated Parkinson's Disease Patients
A Phase 3 study testing Metformin in people with Parkinson Disease, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Metformin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteBangladesh
- Study dates
- 29 Dec 2024to 20 Jul 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed mild to moderate PD patients taking Levodopa
- Age 18 years and older
- Sex : Any
Who cannot join
- Secondary causes of Parkinsonism
- Prior stereotactic surgery for PD
- Suffering from active malignancy
- Known hypersensitivity to metformin
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Metformin as Add-on Therapy in Levodopa Treated Parkinson's Disease Patients: Randomized, Double Blind, Placebo Controlled Trial
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.
Read the 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
- Being tested
- Metformin, placebo
- Keywords
- Metformin, Parkinson disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
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.
placeboOther
placebo of tab. Metformin of same shape
| Study group | Role | What they receive |
|---|---|---|
| Metformin- Patients receiving Levodopa with Metformin | Experimental | Dosage form- Tab. Metformin 500 mg, Frequency - once daily, Duration - 8 weeks Receives: Drug: Metformin |
| Control - Patients receiving Levodopa with Placebo | Placebo comparator | placebo of Tab. Metformin 500 mg, frequency- once daily, duration- 8 weeks Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (3)
1. Plasma Malondealdehyde (MDA) level in micromole/litre. 2. Erythrocyte Glutathione (GSH) level in mg/ml.
Malondealdehyde is oxidative stress marker. Glutathione is anti-oxidant.
Measured: 8 weeks
1. Erythrocyte glutathione level in mg/ml 2. Erythrocyte Glutathione (GSH) level in mg/ml.
Glutathione is an anti-oxidant Glutathione is anti-oxidant.
Measured: 8 weeks
Comparison of adverse effects in percentage
Adverse effects in Metformin treated and placebo treated patients
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start29 Dec 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion20 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RUKHSANA AKTER, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07055958
- Sponsor's protocol ID
- 5246
- Status last verified
- Jul 2025
- First submitted
- 30 May 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Metformin as Add-on Therapy in Levodopa Treated Parkinson's Disease Patients: Randomized, Double Blind, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT07055958
- Acronym / sponsor ID
- 5246
- Conditions
- Parkinson Disease
- Keywords
- Metformin, Parkinson disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- 29 Dec 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 20 Jul 2025 (estimated)
- First posted
- 9 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin- Patients receiving Levodopa with Metformin | Experimental | Drug: MetforminDosage form- Tab. Metformin 500 mg, Frequency - once daily, Duration - 8 weeks |
| Control - Patients receiving Levodopa with Placebo | Placebo comparator | Other: placeboplacebo of Tab. Metformin 500 mg, frequency- once daily, duration- 8 weeks |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed mild to moderate PD patients taking Levodopa
- Age 18 years and older
- Sex : Any
Key exclusion criteria (5 listed)
- Secondary causes of Parkinsonism
- Prior stereotactic surgery for PD
- Suffering from active malignancy
- Known hypersensitivity to metformin
- Pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminMetformin'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. | Drug | Metformin- Patients receiving Levodopa with Metformin |
| placeboplacebo of tab. Metformin of same shape | Other | Control - Patients receiving Levodopa with Placebo |
Primary outcome
motor aspects of daily living
Time frame: 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.
3 secondary outcomes
1. Plasma Malondealdehyde (MDA) level in micromole/litre. 2. Erythrocyte Glutathione (GSH) level in mg/ml.
Time frame: 8 weeks
1. Erythrocyte glutathione level in mg/ml 2. Erythrocyte Glutathione (GSH) level in mg/ml.
Time frame: 8 weeks
Comparison of adverse effects in percentage
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Metformin in people with Parkinson Disease, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
motor aspects of daily living (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.