Celecoxib in Parkinson Disease as Adjuvant Therapy

Tanta University

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Parkinson Disease

Treatments: Drug: Celecoxib 200mg; Drug: Levodopa Carbidopa

Study type: Interventional

Funder types: Other

Identifiers

NCT07246278

5478

Details and patient eligibility

About

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

Enrollment: 80 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Control group

Active Comparator group

Description:

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

Treatment:

Drug: Levodopa Carbidopa

Celecoxib group

Active Comparator group

Description:

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

Treatment:

Drug: Levodopa Carbidopa

Drug: Celecoxib 200mg