Celecoxib in Parkinson Disease as Adjuvant Therapy

NCT ID: NCT07246278

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-20
• Study Completion Date: 2026-11-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control group

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

Group Type: ACTIVE_COMPARATOR

Levodopa Carbidopa

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Levodopa Carbidopa

Intervention Type: 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 200mg

Intervention Type: DRUG

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

Interventions

Levodopa Carbidopa

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

Intervention Type: DRUG

Celecoxib 200mg

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

Intervention Type: DRUG

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
• 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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Mostafa Bahaa

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta Unuversity

Tanta, , Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

Mostafa M I Bahaa, PhD

Role: primary

mbahaa@horus.edu.eg

0201025538337

Other Identifiers

5478

Identifier Type: -

Identifier Source: org_study_id