Metformin in Parkinson Disease

Tanta University

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Parkinson Disease

Treatments: Drug: Levodopa Carbidopa; Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT07229651

4258

Details and patient eligibility

About

The clinical manifestations of Parkinson's disease (PD), a chronic neurodegenerative condition, include resting tremor, hypokinesia, bradykinesia, stiffness and postural instability. These motor symptoms are caused by a selective loss and degeneration of dopaminergic neurons in the substantia nigra pars compacta (SNpc) region, which leads to a dopamine (DA) insufficiency in the striatum

Enrollment: 60 estimated patients

Sex: All

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Control group

Active Comparator group

Description:

Control group (Levo-dopa group, n =30) who will receive levodopa/carbidopa (125/12.5 mg) three times daily for 6 months

Treatment:

Drug: Levodopa Carbidopa

Metformin group

Active Comparator group

Description:

Patients will receive levodopa/carbidopa (125/12.5 mg) three times daily plus metformin 500 mg two times daily for 6 months

Treatment:

Drug: Metformin

Drug: Levodopa Carbidopa