Adding celecoxib to levodopa/carbidopa for Parkinson's disease
Evaluating Safety and Efficacy of Celecoxib in Patients With PD.
This trial will see if giving celecoxib alongside levodopa/carbidopa helps people with Parkinson's disease by lowering inflammation and improving motor symptoms.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta) |
| Trial ID | NCT07246278 on ClinicalTrials.gov |
What this trial studies
This is a Phase 1/2 interventional trial testing celecoxib 200 mg as an add-on to standard levodopa/carbidopa therapy in adults with Parkinson's disease. Participants who meet eligibility will receive celecoxib in addition to their usual dopaminergic medication and will be followed for safety, inflammatory biomarkers (including HMGB1), and clinical motor outcomes. Key exclusions include pregnancy, breastfeeding, significant liver or kidney dysfunction, sulfonamide allergy, current use of other anti-inflammatory drugs, and substance abuse. The trial is conducted at Tanta University with regular clinic visits and laboratory monitoring.
Who should consider this trial
Good fit: Adults aged 18 or older with a clinical diagnosis of Parkinson's disease (per UPDRS) who are not pregnant or breastfeeding, do not have significant liver or kidney dysfunction, are not using other anti-inflammatory drugs, and have no allergy to celecoxib or sulfonamides.
Not a fit: People who are pregnant or breastfeeding, have severe liver or kidney disease, are allergic to celecoxib/sulfonamides, or are currently taking other anti-inflammatory medications would not be eligible and are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, adding celecoxib could reduce neuroinflammation and lead to improved motor symptoms or slower symptom progression in people with Parkinson's disease.
How similar studies have performed: Preclinical work and some small clinical studies suggest anti-inflammatory approaches may help in Parkinson's disease, but using celecoxib as an add-on in this specific context is relatively novel with limited prior clinical evidence.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tanta
- Tanta Unuversity — Tanta, Egypt (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.