Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-01-05 @ 5:32 PM
Study NCT ID:
NCT05962957
Status:
COMPLETED
Last Update Posted:
2025-08-12
First Post:
2023-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Pentoxifylline and Celecoxib in Parkinsonism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'C009265', 'term': 'carbidopa, levodopa drug combination'}, {'id': 'D010431', 'term': 'Pentoxifylline'}, {'id': 'D000068579', 'term': 'Celecoxib'}], 'ancestors': [{'id': 'D013805', 'term': 'Theobromine'}, {'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-10', 'studyFirstSubmitDate': '2023-07-16', 'studyFirstSubmitQcDate': '2023-07-25', 'lastUpdatePostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "- Change From Baseline for Unified Parkinson's Disease Rating Scale (UPDRS) Total Score", 'timeFrame': '6 months', 'description': "\\- Change From Baseline for Unified Parkinson's Disease Rating Scale (UPDRS) Total Score (Time Frame: Baseline and week 24)"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'referencesModule': {'references': [{'pmid': '40253769', 'type': 'DERIVED', 'citation': "Khrieba MO, Hegazy SK, Mohammed WF, El-Haggar SM. Clinical study to investigate the adjuvant role of Pentoxifylline in patients with Parkinson's disease: A randomized controlled study. Int Immunopharmacol. 2025 May 27;156:114689. doi: 10.1016/j.intimp.2025.114689. Epub 2025 Apr 19."}, {'pmid': '39340691', 'type': 'DERIVED', 'citation': 'Khrieba MO, Hegazy SK, Mustafa W, El-Haggar SM. Repurposing celecoxib as adjuvant therapy in patients with Parkinsonian disease: a new therapeutic dawn: randomized controlled pilot study. Inflammopharmacology. 2024 Dec;32(6):3729-3738. doi: 10.1007/s10787-024-01567-z. Epub 2024 Sep 28.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nThe environmental factors are the most common risk factor for Parkinson's disease, while hereditary determinants have minor role for disease. Furthermore, the clinical diagnosis of PD rests on the identification of characteristics related to dopamine deficiency. However, nondopaminergic and nonmotor symptoms, including cognitive dysfunction and depression, which is one of the most common and persistent symptoms, are sometimes present at an earlier disease stage and, almost inevitably, emerge with the disease progression.\n\nNeuroinflammation 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). HMGB1 leads to a sequential cascade of inflammatory response through enhanced release of tumor necrosis factor-alpha (TNF-α) and interleukins (ILs), prominently IL-1β and IL-6. HMGB1 mediated also up-regulation of nuclear factor kappa-β (NF-κB) with subsequent flared pro-inflammatory storm."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 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"}, 'identificationModule': {'nctId': 'NCT05962957', 'briefTitle': 'Role of Pentoxifylline and Celecoxib in Parkinsonism', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': "Clinical Study to Compare the Possible Safety and Efficacy of Pentoxifylline and Celecoxib in Patients With Parkinson's Disease Treated With Conventional Treatment", 'orgStudyIdInfo': {'id': '1235'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'control group ( levo-dopa group, n =25 ) who will receive levo-dopa/carbidopa (125/12.5) mg three times daily for 6 months.', 'interventionNames': ['Drug: carbidopa-levodopa']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PTX group', 'description': '(Pentoxyifylline group, n= 25) will receive levo-dopa/carbidopa (125/12.5) mg three times daily plus pentoxifylline 400 mg two times daily for 6 months.', 'interventionNames': ['Drug: carbidopa-levodopa', 'Drug: Pentoxifylline 400 MG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Celecoxib group', 'description': 'will receive levo-dopa/carbidopa (125/12.5) mg three times daily plus celecoxib 200 mg once daily for 6 months.', 'interventionNames': ['Drug: carbidopa-levodopa', 'Drug: Celecoxib 200mg']}], 'interventions': [{'name': 'carbidopa-levodopa', 'type': 'DRUG', 'description': 'Levodopa is typically prescribed to a patient with Parkinson disease once symptoms become more difficult to control with other anti-parkinsonism drugs. The drug can also be used for postencephalitic parkinsonism and symptomatic parkinsonism due to carbon monoxide intoxication', 'armGroupLabels': ['Celecoxib group', 'PTX group', 'control group']}, {'name': 'Pentoxifylline 400 MG', 'type': 'DRUG', 'description': 'Pentoxifylline (PTX) has a well validated immune modulatory and anti-inflammatory efficacy via suppression of the TLR4/NF-κB network signaling pathway. Moreover, Pentoxifylline has a potential antioxidant capacity mostly via nuclear erythroid 2-related factor 2 (Nrf2) activation with subsequent up-regulation and expression of several antioxidant enzymes', 'armGroupLabels': ['PTX group']}, {'name': 'Celecoxib 200mg', 'type': 'DRUG', 'description': 'Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain and help relieve symptoms of arthritis', 'armGroupLabels': ['Celecoxib group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35511', 'city': 'Al Mansurah', 'country': 'Egypt', 'facility': 'Faculty of Medicine, Mansoura University', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mostafa Bahaa', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tanta University', 'class': 'OTHER'}, {'name': 'Mohanad Omar Khrieba Clinical Pharmacy Department, Faculty of Pharmacy - Horus University', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Teaching assisstant', 'investigatorFullName': 'Mostafa Bahaa', 'investigatorAffiliation': 'Tanta University'}}}}