Metformin added to levodopa/carbidopa for Parkinson's disease
Safety and Efficacy of Metformin in Patients With Parkinson Disaese
PHASE2; PHASE3 · Tanta University · NCT07229651
This will test whether adding metformin to levodopa/carbidopa helps people aged 50 and older with Parkinson's disease.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 50 Years to 70 Years |
| Sex | All |
| Sponsor | Tanta University (other) |
| Locations | 1 site (Tanta) |
| Trial ID | NCT07229651 on ClinicalTrials.gov |
What this trial studies
Participants are adults aged 50 and older with confirmed Parkinson's disease who are already taking levodopa/carbidopa. In this interventional Phase 2/3 protocol, metformin is given in addition to standard levodopa/carbidopa therapy to observe effects on motor symptoms and monitor safety. Key exclusions include secondary or atypical parkinsonism, recent stereotaxic surgery, active malignancy, significant cardiovascular or coagulation disorders, pregnancy or lactation, substance addiction, and concurrent anti-inflammatory drug use. Safety assessments and symptom monitoring are conducted through scheduled clinic visits at the trial site.
Who should consider this trial
Good fit: Ideal candidates are adults aged 50 or older with a confirmed diagnosis of Parkinson's disease who are currently treated with levodopa/carbidopa and meet the trial's safety criteria.
Not a fit: Patients with atypical or secondary parkinsonism, active cancer, significant cardiovascular or coagulation disorders, pregnancy or lactation, current use of excluded medications, or substance addiction are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, adding metformin could improve symptom control or slow disease progression for some patients with Parkinson's disease.
How similar studies have performed: Preclinical studies and some observational data suggest metformin may have neuroprotective effects, but randomized clinical evidence in Parkinson's disease is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Eligible participants were men and women aged 50 years or older with a confirmed diagnosis of PD Patients receiving levodopa/carbidopa therapy. Exclusion Criteria: Secondary causes of parkinsonism Patients taking anti-inflammatory drugs Atypical parkinsonian syndromes Prior stereotaxic surgery for Parkinson's disease Pregnancy and lactation Cardiovascular disease patients Patients with coagulation disorders Suffering from active malignancy Addiction to alcohol and / or drugs Known allergy to the studied medications
Where this trial is running
Tanta
- Tanta University — Tanta, Egypt (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Parkinson Disease