Back to resultsClinical Study to Evaluate the Possible Efficacy of Metformin in Patients With Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
levodopa-carbidopa
Metformin
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
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
Sites / Locations
- Faculty of Medicine, Menoufia UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Control Group
Metformin group
Arm Description
Control group ( Levo-dopa group, n =30 ) who will receive levodopa/carbidopa (50/250 mg) three times daily for 3 months
Patients will receive levodopa/carbidopa (50/250 mg) three times daily plus metformin 500 mg two times daily for 3 months
Outcomes
Primary Outcome Measures
• 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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT05781711
First Posted
March 11, 2023
Last Updated
September 23, 2023
Sponsor
Tanta University
Collaborators
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
1. Study Identification
Unique Protocol Identification Number
NCT05781711
Brief Title
Clinical Study to Evaluate the Possible Efficacy of Metformin in Patients With Parkinson's Disease
Official Title
Clinical Study to Evaluate the Possible Efficacy of Metformin in Patients With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 6, 2023 (Actual)
Primary Completion Date
March 20, 2024 (Anticipated)
Study Completion Date
March 20, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
Collaborators
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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
double-blind
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Experimental
Arm Description
Control group ( Levo-dopa group, n =30 ) who will receive levodopa/carbidopa (50/250 mg) three times daily for 3 months
Arm Title
Metformin group
Arm Type
Active Comparator
Arm Description
Patients will receive levodopa/carbidopa (50/250 mg) three times daily plus metformin 500 mg two times daily for 3 months
Intervention Type
Drug
Intervention Name(s)
levodopa-carbidopa
Intervention Description
levodopa-carbidopa is the standard therapy used in Parkinson's disease
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
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
Primary Outcome Measure Information:
Title
• The primary endpoint is the change in The Unified Parkinson's Disease Rating Scale (UPDRS)
Description
• The primary endpoint is the change in the Unified Parkinson's Disease Rating Scale (UPDRS
Time Frame
3 months
Secondary Outcome Measure Information:
Title
The secondary endpoint is estimated by changes in serum biomarkers.
Description
The secondary endpoint is estimated by changes in serum biomarkers such as brain derived neurotropic factor
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mostafa M Bahaa, PhD
Phone
0201025538337
Email
mbahaa@horus.edu.eg
Facility Information:
Facility Name
Faculty of Medicine, Menoufia University
City
Tanta
State/Province
Shebeen El-Kom
ZIP/Postal Code
32511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manal A Hamouda, PhD
Phone
0201067009096
Email
manal.hamouda@phrm.menofia.edu.eg
12. IPD Sharing Statement
Learn more about this trial
Clinical Study to Evaluate the Possible Efficacy of Metformin in Patients With Parkinson's Disease
We'll reach out to this number within 24 hrs