Celecoxib in Parkinson Disease as Adjuvant Therapy

NCT07246278 | Recruiting Phase 1

• 1 other identifier: 5478
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Parkinson's disease (PD) is a chronic neurodegenerative disease clinically characterized by bradykinesia, hypokinesia, rigidity, resting tremor, and postural instability. These motor manifestations are attributed to the degeneration and selective loss of dopaminergic neurons in the substantia nigra pars compacta (SNpc), leading to a dopamine (DA) deficiency in the striatum. 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

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• change in the Unified Parkinson's Disease Rating Scale

  \- Change From Baseline for Unified Parkinson's Disease Rating Scale (UPDRS) Total Score

  6 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

control group ( levo-dopa group, n =40 ) who will receive levo-dopa/carbidopa (125/12.5) mg three times daily for 6 months.

Drug: Levodopa Carbidopa

Celecoxib group

ACTIVE COMPARATOR

will receive levo-dopa/carbidopa (125/12.5) mg three times daily plus celecoxib 200 mg once daily.

Drug: Levodopa Carbidopa; Drug: Celecoxib 200mg

Interventions

Levodopa Carbidopa DRUG

Carbidopa/levodopa is the combination of the two medications carbidopa and levodopa. It is primarily used to manage the symptoms of Parkinson's disease

Celecoxib group; Control group

Celecoxib 200mg DRUG

Celecoxib, is a selective cyclooxygenase-2 inhibitor. Prostaglandins (PG) are produced from arachidonic acid by the constitutively expressed cyclooxygenase-1(COX-1)

Celecoxib group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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
• Patients with known allergy to sulfonamides (cross hypersensitivity with celecoxib).
• Pregnant women and women with planned pregnancy.
• Patients who are currently using other anti-inflammatory drugs.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta Unuversity

Tanta, 31527, Egypt

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

carbidopa, levodopa drug combination; Celecoxib

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: November 20, 2025
• Primary Completion (Estimated): November 20, 2026
• Study Completion (Estimated): November 28, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-12

Locations

EG (1)