NCT07370532

Brief Summary

Neuroinflammation is considered one of the most important factors contributing critically to pathophysiology of PD . Recently, high mobility group box-1 (HMGB1) protein has been encoded as a potential inflammatory biomarker in PD. HMGB1 mediates immune response mostly through endothelial cells and macrophage activation via targeting two vital cell receptors; Toll-like receptor 4 (TLR4) and advanced glycation end products (RAGE).

Trial Health

77
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
19mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress15%
Jan 2026Nov 2027

First Submitted

Initial submission to the registry

January 17, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 27, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

January 30, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2027

Expected
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2027

Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

1.8 years

First QC Date

January 17, 2026

Last Update Submit

April 2, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • - Change in The Unified Parkinson's Disease Rating Scale

    \- Change in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score

    6 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

(levo-dopa group, n =30) who will receive levo-dopa/carbidopa (125/12.5) mg three times daily for 6 months.

Drug: L-dopa

Etoricoxib group

ACTIVE COMPARATOR

will receive levo-dopa/carbidopa (125/12.5) mg three times daily plus Etoricoxib 90 mg once daily

Drug: L-dopaDrug: Etoricoxib

Interventions

L-dopaDRUG

Levodopa is the standard therapy in PD.

Control groupEtoricoxib group

Etoricoxib, is a selective cyclooxygenase-2 inhibitor. Prostaglandins (PG) are produced from arachidonic acid by the constitutively expressed cyclooxygenase-1(COX-1) and by the inducible COX-2 enzymes and are secreted mainly by astrocytes and microglia.

Etoricoxib group

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18 years.
  • Both male and female will be included.
  • Patients diagnosed with PD according to Unified Parkinson's Disease Rating Scale.

You may not qualify if:

  • Breast feeding
  • Patients with significant liver and kidney function abnormalities.
  • Alcohol and / or drug abusers.
  • Patients with known allergy to the study medications
  • Pregnant women and women with planned pregnancy.
  • Patients who are currently using other anti-inflammatory drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, 26548, Egypt

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

LevodopaEtoricoxib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

DihydroxyphenylalanineCatecholaminesAminesOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsTyrosineSulfonesSulfur CompoundsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 17, 2026

First Posted

January 27, 2026

Study Start

January 30, 2026

Primary Completion (Estimated)

November 10, 2027

Study Completion (Estimated)

November 20, 2027

Last Updated

April 8, 2026

Record last verified: 2026-04

Locations