Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 12:11 AM
Study NCT ID:
NCT07370532
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-27
First Post:
2026-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Etoricoxib in Patients With Parkinsonian Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007980', 'term': 'Levodopa'}, {'id': 'D000077613', 'term': 'Etoricoxib'}], 'ancestors': [{'id': 'D004295', 'term': 'Dihydroxyphenylalanine'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010649', 'term': 'Phenylalanine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014443', 'term': 'Tyrosine'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-11-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-17', 'studyFirstSubmitDate': '2026-01-17', 'studyFirstSubmitQcDate': '2026-01-17', 'lastUpdatePostDateStruct': {'date': '2026-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "- Change in The Unified Parkinson's Disease Rating Scale", 'timeFrame': '6 months', 'description': "\\- Change in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': '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. HMGB1 mediates immune response mostly through endothelial cells and macrophage activation via targeting two vital cell receptors; Toll-like receptor 4 (TLR4) and advanced glycation end products (RAGE).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Both male and female will be included.\n* Patients diagnosed with PD according to Unified Parkinson's Disease Rating Scale.\n\nExclusion Criteria:\n\n* Breast feeding\n* Patients with significant liver and kidney function abnormalities.\n* Alcohol and / or drug abusers.\n* Patients with known allergy to the study medications\n* Pregnant women and women with planned pregnancy.\n* Patients who are currently using other anti-inflammatory drugs."}, 'identificationModule': {'nctId': 'NCT07370532', 'briefTitle': 'Etoricoxib in Patients With Parkinsonian Disease', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': "Clinical Study to Evaluate Safety and Efficacy of Etoricoxib in Patients With Parkinson's Disease Treated With Conventional Treatment", 'orgStudyIdInfo': {'id': '98658'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': '(levo-dopa group, n =30) who will receive levo-dopa/carbidopa (125/12.5) mg three times daily for 6 months.', 'interventionNames': ['Drug: L-dopa']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Etoricoxib group', 'description': 'will receive levo-dopa/carbidopa (125/12.5) mg three times daily plus Etoricoxib 90 mg once daily', 'interventionNames': ['Drug: L-dopa', 'Drug: Etoricoxib']}], 'interventions': [{'name': 'L-dopa', 'type': 'DRUG', 'description': 'Levodopa is the standard therapy in PD.', 'armGroupLabels': ['Control group', 'Etoricoxib group']}, {'name': 'Etoricoxib', 'type': 'DRUG', 'description': 'Etoricoxib, is a selective cyclooxygenase-2 inhibitor. Prostaglandins (PG) are produced from arachidonic acid by the constitutively expressed cyclooxygenase-1(COX-1) and by the inducible COX-2 enzymes and are secreted mainly by astrocytes and microglia.', 'armGroupLabels': ['Etoricoxib group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '26548', 'city': 'Al Mansurah', 'country': 'Egypt', 'contacts': [{'name': 'Ehab Hassan, PhD', 'role': 'CONTACT', 'email': 'Ehassan@horus.edu.eg', 'phone': '01067831661'}], 'facility': 'Mansoura University', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ihab Elsayed Hassan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Ihab Elsayed Hassan', 'investigatorAffiliation': 'Tanta University'}}}}