Pentoxifylline and Parkinsonism
Primary Purpose
Parkinson Disease
Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
carbidopa-levodopa
Pentoxifylline 400 MG
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility 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
Sites / Locations
- Faculty of Medicine, Mansoura UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
control group
PTX group
Arm Description
control group ( levo-dopa group, n =25 ) who will receive levo-dopa/carbidopa (125/12.5) mg three times daily for 6 months.
(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.
Outcomes
Primary Outcome Measures
- Change From Baseline for Unified Parkinson's Disease Rating Scale (UPDRS) Total Score
- Change From Baseline for Unified Parkinson's Disease Rating Scale (UPDRS) Total Score (Time Frame: Baseline and week 24)
Secondary Outcome Measures
Full Information
NCT ID
NCT05962957
First Posted
July 16, 2023
Last Updated
August 22, 2023
Sponsor
Mostafa Bahaa
Collaborators
Sahar Mohamed El-Haggar clinical pharmacy department, Tanta University, Sahar Kamal Hegazi clinical pharmacy department, Tanta University, Mohanad Omar Khrieba Clinical Pharmacy Department, Faculty of Pharmacy - Horus University
1. Study Identification
Unique Protocol Identification Number
NCT05962957
Brief Title
Pentoxifylline and Parkinsonism
Official Title
Clinical Study to Compare the Possible Safety and Efficacy of Pentoxifylline in Patients With Parkinson's Disease Treated With Conventional Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 7, 2023 (Actual)
Primary Completion Date
July 20, 2027 (Anticipated)
Study Completion Date
October 20, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mostafa Bahaa
Collaborators
Sahar Mohamed El-Haggar clinical pharmacy department, Tanta University, Sahar Kamal Hegazi clinical pharmacy department, Tanta University, Mohanad Omar Khrieba Clinical Pharmacy Department, Faculty of Pharmacy - Horus University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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 (SNpc), leading to a dopamine (DA) deficiency in the striatum.
The 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.
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). 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Double blinded
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Active Comparator
Arm Description
control group ( levo-dopa group, n =25 ) who will receive levo-dopa/carbidopa (125/12.5) mg three times daily for 6 months.
Arm Title
PTX group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
carbidopa-levodopa
Intervention 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
Intervention Type
Drug
Intervention Name(s)
Pentoxifylline 400 MG
Intervention 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
Primary Outcome Measure Information:
Title
- Change From Baseline for Unified Parkinson's Disease Rating Scale (UPDRS) Total Score
Description
- Change From Baseline for Unified Parkinson's Disease Rating Scale (UPDRS) Total Score (Time Frame: Baseline and week 24)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Faculty of Medicine, Mansoura University
City
Mansoura
ZIP/Postal Code
35511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mostafa M Bahaa, PhD
Phone
0201025538337
Email
mbahaa@horus.edu.eg
12. IPD Sharing Statement
Learn more about this trial
Pentoxifylline and Parkinsonism
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