Clinical Study to Evaluate the Possible Efficacy of Metformin in Patients With Parkinson's Disease

Sponsor

Tanta University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05781711

Collaborator

Eman Ibrahim Elberri, Faculty of Pharmacy, Tanta University (Other), Fedaa Abd El-monem Kamal El-deen Kotkata Faculty of Pharmacy, Tanta University (Other), Manal Ali Mahrous Hamouda Faculty of Pharmacy, Menufia University (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Drug: levodopa-carbidopa Drug: Metformin	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

double-blind

Primary Purpose:

Treatment

Official Title:

Clinical Study to Evaluate the Possible Efficacy of Metformin in Patients With Parkinson's Disease

Anticipated Study Start Date :

Mar 20, 2023

Anticipated Primary Completion Date :

Mar 20, 2024

Anticipated Study Completion Date :

Mar 20, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Control Group Control group ( Levo-dopa group, n =30 ) who will receive levodopa/carbidopa (50/250 mg) two times daily for 3 months	Drug: levodopa-carbidopa levodopa-carbidopa is the standard therapy used in Parkinson's disease
Active Comparator: Metformin group Patients will receive levodopa/carbidopa (50/250 mg) two times daily plus metformin 850 mg two times daily for 3 months	Drug: levodopa-carbidopa levodopa-carbidopa is the standard therapy used in Parkinson's disease Drug: Metformin 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

Arm

Intervention/Treatment

Experimental: Control Group

Control group ( Levo-dopa group, n =30 ) who will receive levodopa/carbidopa (50/250 mg) two times daily for 3 months

Drug: levodopa-carbidopa

levodopa-carbidopa is the standard therapy used in Parkinson's disease

Active Comparator: Metformin group

Patients will receive levodopa/carbidopa (50/250 mg) two times daily plus metformin 850 mg two times daily for 3 months

Drug: levodopa-carbidopa

levodopa-carbidopa is the standard therapy used in Parkinson's disease

Drug: Metformin

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

Outcome Measures

Primary Outcome Measures

• The primary endpoint is the change in The Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [3 months]
• The primary endpoint is the change in The Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

Secondary Outcome Measures

The secondary endpoint is estimated by changes in serum biomarkers. [3 months]
The secondary endpoint is estimated by changes in serum biomarkers such as brain derived neurotropic factor

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Months to 75 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥ 18 years Both males and females will be included Negative pregnancy test and effective contraception. Diagnosed Parkinson's disease patient taking Levodopa

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine, Menoufia University	Tanta	Shebeen El-Kom	Egypt	32511

Sponsors and Collaborators

Tanta University
Eman Ibrahim Elberri, Faculty of Pharmacy, Tanta University
Fedaa Abd El-monem Kamal El-deen Kotkata Faculty of Pharmacy, Tanta University
Manal Ali Mahrous Hamouda Faculty of Pharmacy, Menufia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mostafa Bahaa, Teaching Assistant, Tanta University

ClinicalTrials.gov Identifier:

NCT05781711

Other Study ID Numbers:

3-2023

First Posted:

Mar 23, 2023

Last Update Posted:

Mar 23, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Carbidopa, levodopa drug combination

Study Results

No Results Posted as of Mar 23, 2023