Parkinson DiseasePhase 2NCT05781711
Clinical Study to Evaluate the Possible Efficacy of Metformin in Patients With Parkinson's Disease
A Phase 2 study testing levodopa-carbidopa and Metformin in people with Parkinson Disease, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- levodopa-carbidopa and Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Jun 2023to 20 Aug 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 50 years Both males and females will be included Negative pregnancy test and effective contraception. Diagnosed Parkinson's disease patient taking Levodopa
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine, Menoufia University
Tanta, Shebeen El-Kom, 32511
About this study
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
- Conditions
- Parkinson Disease
- Being tested
- levodopa-carbidopa, Metformin
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levodopa-carbidopaDrug
levodopa-carbidopa is the standard therapy used in Parkinson's disease
MetforminDrug
Metformin, a biguanide family member commonly used in treatment for type 2 diabetes, appears to increase liver and peripheral tissue sensitivity to insulin as well as reduce hepatic glucose production
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Experimental | Control group ( Levo-dopa group, n =30 ) who will receive levodopa/carbidopa (25/250 mg) three times daily for 3 months Receives: Drug: levodopa-carbidopa |
| Metformin group | Active comparator | Patients will receive levodopa/carbidopa (25/250 mg) three times daily plus metformin 500 mg two times daily for 3 months Receives: Drug: levodopa-carbidopa; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
• The primary endpoint is the change in The Unified Parkinson's Disease Rating Scale (UPDRS)
- The primary endpoint is the change in the Unified Parkinson's Disease Rating Scale (UPDRS
Measured: 3 months
Secondary outcomes (1)
The secondary endpoint is estimated by changes in serum biomarkers.
The secondary endpoint is estimated by changes in serum biomarkers such as brain derived neurotropic factor
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start6 Jun 2023
- Primary completion20 Aug 2024
- Study completion20 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Collaborators
- Menoufia University
- Responsible party
- Principal investigator, Mostafa Bahaa, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781711
- Sponsor's protocol ID
- 3-2023
- Status last verified
- Oct 2026
- First submitted
- 11 Mar 2023
- Last updated
- 30 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
AlRasheed HA, Bahaa MM, Elmasry TA, Elberri EI, Kotkata FA, El Sabaa RM, Elmorsi YM, Kamel MM, Negm WA, Hamouda AO, Aldossary KM, Salahuddin MM, Yasser M, Eldesouqui M, Hamouda MA, Eltantawy N, Elawady ME, Abdallah MS. Randomized, double-blind, placebo-controlled pilot study of metformin as an adjunctive therapy in Parkinson's disease. Front Pharmacol. 2025 May 2;16:1497261. doi: 10.3389/fphar.2025.1497261. eCollection 2025.
PubMed 40385486
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Possible Efficacy of Metformin in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05781711
- Acronym / sponsor ID
- 3-2023
- Conditions
- Parkinson Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Collaborators
- Menoufia University
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 23 Mar 2023 (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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Experimental | Drug: levodopa-carbidopaControl group ( Levo-dopa group, n =30 ) who will receive levodopa/carbidopa (25/250 mg) three times daily for 3 months |
| Metformin group | Active comparator | Drug: levodopa-carbidopa, Drug: MetforminPatients will receive levodopa/carbidopa (25/250 mg) three times daily plus metformin 500 mg two times daily for 3 months |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age ≥ 50 years Both males and females will be included Negative pregnancy test and effective contraception. Diagnosed Parkinson's disease patient taking Levodopa
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| levodopa-carbidopalevodopa-carbidopa is the standard therapy used in Parkinson's disease | Drug | Control Group, Metformin group |
| MetforminMetformin, a biguanide family member commonly used in treatment for type 2 diabetes, appears to increase liver and peripheral tissue sensitivity to insulin as well as reduce hepatic glucose production | Drug | Metformin group |
Primary outcome
• The primary endpoint is the change in The Unified Parkinson's Disease Rating Scale (UPDRS)
Time frame: 3 months
• The primary endpoint is the change in the Unified Parkinson's Disease Rating Scale (UPDRS
1 secondary outcome
The secondary endpoint is estimated by changes in serum biomarkers.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Derived from this study: PubMed 40385486AlRasheed HA, Bahaa MM, Elmasry TA, Elberri EI, Kotkata FA, El Sabaa RM, Elmorsi YM, Kamel MM, Negm WA, Hamouda AO, Aldossary KM, Salahuddin MM, Yasser M, Eldesouqui M, Hamouda MA, Eltantawy N, Elawady ME, Abdallah MS. Randomized, double-blind, placebo-controlled pilot study of metformin as an adjunctive therapy in Parkinson's disease. Front Pharmacol. 2025 May 2;16:1497261. doi: 10.3389/fphar.2025.1497261. eCollection 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 2 study testing levodopa-carbidopa and Metformin in people with Parkinson Disease, run by Tanta University at 1 site in Egypt.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 30 Oct 2026. 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 Egypt. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
• The primary endpoint is the change in The Unified Parkinson's Disease Rating Scale (UPDRS) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05781711, which also lists 1 linked publication.
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 30 Oct 2026.