NCT07806019

Brief Summary

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)

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
4mo left

Started Aug 2026

Shorter than P25 for phase_4

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress23%
Aug 2026Feb 2027

First Submitted

Initial submission to the registry

August 20, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

August 28, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 8, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

September 9, 2026

Status Verified

August 1, 2026

Enrollment Period

5 months

First QC Date

August 20, 2026

Last Update Submit

September 7, 2026

Conditions

Parkinsons Disease (PD)

Keywords

Parkinson's diseaseNeuroinflamationMetforminAlpha synucleinMDA levelsMDS-UPDRS

Outcome Measures

Primary Outcomes (3)

  • 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.

    12weeks

  • MDA levels

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

    12 weeks

  • Alpha Synuclein levels

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

    12 weeks

Secondary Outcomes (4)

  • Safety profile of metformin

    From baseline to Week 12

  • Safety Profile of Metformin

    From baseline to week 12

  • Safety Profile of Metformin

    Baseline to weeks 12

  • Safety Profile of Metformin

    From baseline to week 12

Study Arms (2)

Group A (satndard treatment group) control group

NO INTERVENTION

patients will continue standard therapy with carbidopa levodopa 250/25 mg TDS

Group B (Metformin group)

ACTIVE COMPARATOR

patients will receive 500mg Metformin BD for 12 weeks along with standard treatment with carbidopa levodopa 250/25mg TDS

Drug: Metformin 500mg

Interventions

Metformin 500mgDRUG

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

Group B (Metformin group)

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients diagnosed with primary PD age 50-70 years receiving levodopa + carbidopa. Diagnosis will be made in accordance with movement disorder society clinical diagnostic criteria for Parkinson's disease

You may not qualify if:

  • Secondary Parkinsonism co-morbid (such as Diabetes mellitus, Cardio-vascular diseases, Senile tremors, Wilson's disease, Cancers etc.) Pregnant and lactating mothers Sensitivity to metformin Lactic acidosis History of alcohol use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Parkinson DiseaseParkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

Metformin

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Central Study Contacts

Syeda Midhat Zaidi, MBBS

CONTACT

+923342434378drmidhatzehra@gmail.com

Nasim Karim, MBBS, MPhil, PhD, Post-doc

CONTACT

+923323151774nsm_karim@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Masking Description
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Model Description
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2026

First Posted

September 8, 2026

Study Start

August 28, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

September 9, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share