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Metformin in Parkinson's Disease: Safety and Efficacy

ConditionParkinsons Disease (PD)
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age50-70
SponsorJinnah Medical & Dental College

About this trial

This study will evaluate whether metformin when it will be given to patients with Parkinson's disease along with standard therapy (levodopa carbidopa) will improve motor symptoms and decreases levels of alpha synuclein and MDA in patients with PD as compare to PD patients receiving only standard therapy (levodopa carbidopa)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Metformin 500mg

    Drug

    Metformin will be given to the group B along with the standard treatment

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Group A (satndard treatment group) control groupNo intervention 0 interventions
Group B: Group B (Metformin group)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

MDS-UPDRS

Change in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score from baseline to 12 weeks to assess changes in Parkinson disease symptoms. The MDS-UPDRS (Movement Disorder Society-Unified Parkinson's Disease Rating Scale) is the standard scale used to assess the severity and progression of Parkinson's disease (PD) and response to treatment. It has 4 parts. Part I Non-motor experiences of daily living 52 Part II Motor experiences of daily living 52 Part III Motor examination performed by clinician 132 Part IV Motor complications of treatment, e.g., dyskinesia and fluctuations 24 Total score: 260 Each item is generally scored: 0 = Normal / no problem 1. = Slight 2. = Mild 3. = Moderate 4. = Severe Higher scores represents greater severity of Parkinson's disease.

Time frame
12weeks
2

MDA levels

Change in malondialdehyde (MDA) levels from baseline to 12 weeks to asses changes in oxidative stress

Time frame
12 weeks
3

Alpha Synuclein levels

Change in serum alpha-synuclein concentration from baseline to 12 weeks

Time frame
12 weeks

Secondary outcomes

1

Safety profile of metformin

Safety profile of the interventional drug (metformin) will be assed in Group B (intervention group) 30 patients. blood samples will be taken for blood (CBC) to check hemoglobin levels

Time frame
From baseline to Week 12
2

Safety Profile of Metformin

Safety profile of the interventional drug (metformin) will be assed in Group B (intervention group) 30 patients. blood samples will be taken to assess the Renal side effects of drug by measuring Urea, creatinine, GFR

Time frame
From baseline to week 12
3

Safety Profile of Metformin

Safety profile of the interventional drug (metformin) will be assed in Group B (intervention group) 30 patients. blood samples will be taken to assess the hepatic side effects of drug by measuring ALT,AST

Time frame
Baseline to weeks 12
4

Safety Profile of Metformin

Safety profile of the interventional drug (metformin) will be assed in Group B (intervention group) 30 patients. blood samples will be taken to assess the Cardiac side effects of drug by measuring TGs, HDL

Time frame
From baseline to week 12

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jinnah Medical & Dental College

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: