Parkinson DiseasePhase 1/2NCT07246278
Celecoxib in Parkinson Disease as Adjuvant Therapy
A Phase 1/2 study testing Levodopa Carbidopa and Celecoxib 200mg in people with Parkinson Disease, run by Tanta University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Levodopa Carbidopa and Celecoxib 200mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Nov 2025to 28 Nov 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Both male and female will be included.
- Patients diagnosed with PD according to Unified Parkinson's Disease Rating Scale.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta Unuversity
Tanta, 31527
Mostafa M I Bahaa, PhD, 0201025538337, mbahaa@horus.edu.eg
Mostafa M Bahaa, PhD
About this study
Official title: Evaluating Safety and Efficacy of Celecoxib in Patients With PD.
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
- Being tested
- Levodopa Carbidopa, Celecoxib 200mg
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levodopa CarbidopaDrug
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 200mgDrug
Celecoxib, is a selective cyclooxygenase-2 inhibitor. Prostaglandins (PG) are produced from arachidonic acid by the constitutively expressed cyclooxygenase-1(COX-1)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Levodopa Carbidopa; Drug: Celecoxib 200mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the Unified Parkinson's Disease Rating Scale
- Change From Baseline for Unified Parkinson's Disease Rating Scale (UPDRS) Total Score
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start20 Nov 2025
- Primary completion20 Nov 2026 (estimated)
- Study completion28 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Bahaa, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246278
- Sponsor's protocol ID
- 5478
- Status last verified
- Dec 2025
- First submitted
- 17 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Safety and Efficacy of Celecoxib in Patients With PD.
- ClinicalTrials.gov ID
- NCT07246278
- Acronym / sponsor ID
- 5478
- Conditions
- Parkinson Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- 20 Nov 2026 (estimated)
- Study completion
- 28 Nov 2026 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: Levodopa Carbidopacontrol group ( levo-dopa group, n =40 ) who will receive levo-dopa/carbidopa (125/12.5) mg three times daily for 6 months. |
| Celecoxib group | Active comparator | Drug: Levodopa Carbidopa, Drug: Celecoxib 200mgwill receive levo-dopa/carbidopa (125/12.5) mg three times daily plus celecoxib 200 mg once daily. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years.
- Both male and female will be included.
- Patients diagnosed with PD according to Unified Parkinson's Disease Rating Scale.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levodopa CarbidopaCarbidopa/levodopa is the combination of the two medications carbidopa and levodopa. It is primarily used to manage the symptoms of Parkinson's disease | Drug | Celecoxib group, Control group |
| Celecoxib 200mgCelecoxib, is a selective cyclooxygenase-2 inhibitor. Prostaglandins (PG) are produced from arachidonic acid by the constitutively expressed cyclooxygenase-1(COX-1) | Drug | Celecoxib group |
Primary outcome
change in the Unified Parkinson's Disease Rating Scale
Time frame: 6 months
- Change From Baseline for Unified Parkinson's Disease Rating Scale (UPDRS) Total Score
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Levodopa Carbidopa and Celecoxib 200mg in people with Parkinson Disease, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in the Unified Parkinson's Disease Rating Scale (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.