xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05962957</url>
    </required_header>
    <id_info>
      <org_study_id>1235</org_study_id>
      <nct_id>NCT05962957</nct_id>
    </id_info>
    <brief_title>Pentoxifylline and Parkinsonism</brief_title>
    <official_title>Clinical Study to Compare the Possible Safety and Efficacy of Pentoxifylline in Patients With Parkinson's Disease Treated With Conventional Treatment</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mostafa Bahaa</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Sahar Mohamed El-Haggar clinical pharmacy department, Tanta University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Sahar Kamal Hegazi clinical pharmacy department, Tanta University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Mohanad Omar Khrieba Clinical Pharmacy Department, Faculty of Pharmacy - Horus University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Tanta University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Parkinson's disease (PD) is a chronic neurodegenerative disease clinically characterized by&#xD;
        bradykinesia, hypokinesia, rigidity, resting tremor, and postural instability. These motor&#xD;
        manifestations are attributed to the degeneration and selective loss of dopaminergic neurons&#xD;
        in the substantia nigra pars compacta (SNpc), leading to a dopamine (DA) deficiency in the&#xD;
        striatum.&#xD;
  &#xD;
        The environmental factors are the most common risk factor for Parkinson's disease, while&#xD;
        hereditary determinants have minor role for disease. Furthermore, the clinical diagnosis of&#xD;
        PD rests on the identification of characteristics related to dopamine deficiency. However,&#xD;
        nondopaminergic and nonmotor symptoms, including cognitive dysfunction and depression, which&#xD;
        is one of the most common and persistent symptoms, are sometimes present at an earlier&#xD;
        disease stage and, almost inevitably, emerge with the disease progression.&#xD;
  &#xD;
        Neuroinflammation is considered one of the most important factors contributing critically to&#xD;
        pathophysiology of PD . Recently, high mobility group box-1 (HMGB1) protein has been encoded&#xD;
        as a potential inflammatory biomarker in PD. HMGB1 mediates immune response mostly through&#xD;
        endothelial cells and macrophage activation via targeting two vital cell receptors; Toll-like&#xD;
        receptor 4 (TLR4) and advanced glycation end products (RAGE). HMGB1 leads to a sequential&#xD;
        cascade of inflammatory response through enhanced release of tumor necrosis factor-alpha&#xD;
        (TNF-α) and interleukins (ILs), prominently IL-1β and IL-6. HMGB1 mediated also up-regulation&#xD;
        of nuclear factor kappa-β (NF-κB) with subsequent flared pro-inflammatory storm.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 7, 2023</start_date>
    <completion_date type="Anticipated">October 20, 2028</completion_date>
    <primary_completion_date type="Anticipated">July 20, 2027</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
      <masking_description>Double blinded</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>- Change From Baseline for Unified Parkinson's Disease Rating Scale (UPDRS) Total Score</measure>
      <time_frame>6 months</time_frame>
      <description>- Change From Baseline for Unified Parkinson's Disease Rating Scale (UPDRS) Total Score (Time Frame: Baseline and week 24)</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Parkinson Disease</condition>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>control group ( levo-dopa group, n =25 ) who will receive levo-dopa/carbidopa (125/12.5) mg three times daily for 6 months.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>PTX group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>carbidopa-levodopa</intervention_name>
      <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</description>
      <arm_group_label>PTX group</arm_group_label>
      <arm_group_label>control group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Pentoxifylline 400 MG</intervention_name>
      <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</description>
      <arm_group_label>PTX group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 18 years.&#xD;
  &#xD;
            -  Both male and female will be included.&#xD;
  &#xD;
            -  Patients diagnosed with PD according to Unified Parkinson's Disease Rating Scale.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Breast feeding&#xD;
  &#xD;
            -  Patients with significant liver and kidney function abnormalities.&#xD;
  &#xD;
            -  Alcohol and / or drug abusers.&#xD;
  &#xD;
            -  Patients with known allergy to the study medications&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Faculty of Medicine, Mansoura University</name>
        <address>
          <city>Mansoura</city>
          <zip>35511</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mostafa M Bahaa, PhD</last_name>
        <phone>0201025538337</phone>
        <email>mbahaa@horus.edu.eg</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 16, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Tanta University</investigator_affiliation>
      <investigator_full_name>Mostafa Bahaa</investigator_full_name>
      <investigator_title>Teaching assisstant</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Parkinson Disease</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pentoxifylline</mesh_term>
      <mesh_term>Levodopa</mesh_term>
      <mesh_term>Carbidopa</mesh_term>
      <mesh_term>Carbidopa, levodopa drug combination</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05962957
  org study id: 1235
  nct id: NCT05962957
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  masking description: Double blinded
  measure: - Change From Baseline for Unified Parkinson's Disease Rating Scale (UPDRS) Total Score
  time frame: 6 months
  description: - Change From Baseline for Unified Parkinson's Disease Rating Scale (UPDRS) Total Score (Time Frame: Baseline and week 24)
  arm group label: control group
  arm group type: Active Comparator
  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 group label: PTX group
  arm group type: Active Comparator
  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: carbidopa-levodopa
  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
  arm group label: PTX group
  arm group label: control group
  intervention type: Drug
  intervention name: Pentoxifylline 400 MG
  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
  arm group label: PTX group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  responsible party type: Sponsor-Investigator
  investigator affiliation: Tanta University
  investigator full name: Mostafa Bahaa
  investigator title: Teaching assisstant
  mesh term: Parkinson Disease
  mesh term: Pentoxifylline
  mesh term: Levodopa
  mesh term: Carbidopa
  mesh term: Carbidopa, levodopa drug combination