Etoricoxib in Patients With Parkinsonian Disease | NCT07370532

Studies
Etoricoxib in Patients With Parkinsonian Disease

NCT07370532

Sponsor

Ihab Elsayed Hassan

Status

Recruiting

Last Update Posted

Apr 8, 2026Actual

Enrollment

60Estimated

Phase

Phase 2

Conditions

Parkinson Disease

Interventions

L-dopa
Etoricoxib

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 30, 2026Actual

Primary Completion Date

Nov 10, 2027Estimated

Completion Date

Nov 20, 2027Estimated

First Submitted Date

Jan 17, 2026

First Submission Date that Met QC Criteria

Jan 17, 2026

First Posted Date

Jan 27, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2026

Last Update Posted Date

Apr 8, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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-dopa Drug: Etoricoxib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
L-dopa	Drug	Levodopa is the standard therapy in PD.	Control group Etoricoxib group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
- Change in The Unified Parkinson's Disease Rating Scale	- Change in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mansoura University	Recruiting	Al Mansurah		26548	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007980	Levodopa
D000077613	Etoricoxib

Ancestor Terms

ID	Term
D004295	Dihydroxyphenylalanine
D002395	Catecholamines
D000588	Amines
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided