Metformin in Parkinson Disease

NCT07229651 | Recruiting Phase 2

• 1 other identifier: 4258
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• change in The Unified Parkinson's Disease Rating Scale (UPDRS).

  The unified Parkinson's disease rating scale is used to follow the longitudinal course of Parkinson's disease. The UPD rating scale is the most commonly used scale in the clinical study of Parkinson's disease.

  6 months

Secondary Outcomes (1)

• Change in PDQ-39

  6 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

Drug: Levodopa Carbidopa

Metformin group

ACTIVE COMPARATOR

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

Drug: Levodopa Carbidopa; Drug: Metformin

Interventions

Levodopa Carbidopa DRUG

Carbidopa/levodopa, also known as levocarb and co-careldopa, is the combination of the two medications carbidopa and levodopa. It is primarily used to manage the symptoms of Parkinson's disease

Control group; Metformin group

Metformin DRUG

Metformin, sold under the brand name Glucophage, among others, is the main first-line medication for the treatment of type 2 diabetes, particularly in people who are overweight.

Metformin group

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible participants were men and women aged 50 years or older with a confirmed diagnosis of PD Patients receiving levodopa/carbidopa therapy.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, 31511, Egypt

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

carbidopa, levodopa drug combination; Metformin

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: November 10, 2025
• Primary Completion (Estimated): November 20, 2026
• Study Completion (Estimated): September 20, 2027
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

EG (1)