Pentoxifylline and Parkinsonism

Sponsor

Mostafa Bahaa (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05962957

Collaborator

Sahar Mohamed El-Haggar clinical pharmacy department, Tanta University (Other), Sahar Kamal Hegazi clinical pharmacy department, Tanta University (Other), Mohanad Omar Khrieba Clinical Pharmacy Department, Faculty of Pharmacy - Horus University (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Drug: carbidopa-levodopa Drug: Pentoxifylline 400 MG	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

Double blinded

Primary Purpose:

Treatment

Official Title:

Clinical Study to Compare the Possible Safety and Efficacy of Pentoxifylline in Patients With Parkinson's Disease Treated With Conventional Treatment

Anticipated Study Start Date :

Jul 20, 2023

Anticipated Primary Completion Date :

Jul 20, 2027

Anticipated Study Completion Date :

Oct 20, 2028

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: control group control group ( levo-dopa group, n =25 ) who will receive levo-dopa/carbidopa (125/12.5) mg three times daily for 6 months.	Drug: carbidopa-levodopa 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
Active Comparator: PTX group (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.	Drug: carbidopa-levodopa 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 Drug: Pentoxifylline 400 MG 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

Arm

Intervention/Treatment

Active Comparator: control group

control group ( levo-dopa group, n =25 ) who will receive levo-dopa/carbidopa (125/12.5) mg three times daily for 6 months.

Drug: carbidopa-levodopa

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

Active Comparator: PTX group

(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.

Drug: carbidopa-levodopa

Drug: Pentoxifylline 400 MG

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

Outcome Measures

Primary Outcome Measures

- Change From Baseline for Unified Parkinson's Disease Rating Scale (UPDRS) Total Score [6 months]
- Change From Baseline for Unified Parkinson's Disease Rating Scale (UPDRS) Total Score (Time Frame: Baseline and week 24)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine, Mansoura University	Mansoura		Egypt	35511

Sponsors and Collaborators

Mostafa Bahaa
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