NCT05781711

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2 parkinson-disease

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 23, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2025

Completed
Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

March 11, 2023

Last Update Submit

March 12, 2026

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

  • • 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

    3 months

Secondary Outcomes (1)

  • The secondary endpoint is estimated by changes in serum biomarkers.

    3 months

Study Arms (2)

Control Group

EXPERIMENTAL

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

Drug: levodopa-carbidopa

Metformin group

ACTIVE COMPARATOR

Patients will receive levodopa/carbidopa (50/250 mg) three times daily plus metformin 500 mg two times daily for 3 months

Drug: levodopa-carbidopaDrug: Metformin

Interventions

levodopa-carbidopaDRUG

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

Control GroupMetformin group
MetforminDRUG

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

Metformin group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Menoufia University

Tanta, Shebeen El-Kom, 32511, Egypt

Location

Related Publications (1)

  • AlRasheed HA, Bahaa MM, Elmasry TA, Elberri EI, Kotkata FA, El Sabaa RM, Elmorsi YM, Kamel MM, Negm WA, Hamouda AO, Aldossary KM, Salahuddin MM, Yasser M, Eldesouqui M, Hamouda MA, Eltantawy N, Elawady ME, Abdallah MS. Randomized, double-blind, placebo-controlled pilot study of metformin as an adjunctive therapy in Parkinson's disease. Front Pharmacol. 2025 May 2;16:1497261. doi: 10.3389/fphar.2025.1497261. eCollection 2025.

    PMID: 40385486DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

carbidopa, levodopa drug combinationMetformin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
double-blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching Assistant

Study Record Dates

First Submitted

March 11, 2023

First Posted

March 23, 2023

Study Start

January 6, 2023

Primary Completion

January 20, 2025

Study Completion

January 20, 2025

Last Updated

March 13, 2026

Record last verified: 2026-03

Locations

EG(1)