<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/NCT03767452</url>
  </required_header>
  <id_info>
    <org_study_id>MMR032018</org_study_id>
    <nct_id>NCT03767452</nct_id>
  </id_info>
  <brief_title>Additional Xiaflex® Treatment in Patients With Peyronie's Disease Recurrence, Worsening, or Incomplete Response</brief_title>
  <official_title>A Phase 4, Single-Center, Multiple-Dose, Open-Label Trial to Evaluate the Efficacy of Additional Xiaflex® Treatment in Patients With Peyronie's Disease Recurrence, Worsening, or Incomplete Response After Prior Xiaflex® Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Manhattan Medical Research Practice, PLLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Endo Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Manhattan Medical Research Practice, PLLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Subjects who have had an incomplete response to previous Xiaflex® will receive up to 4&#xD;
      additional cycles of treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 4, 2018</start_date>
  <completion_date type="Anticipated">February 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the degree of penile curvature</measure>
    <time_frame>From Screening up to 24 weeks</time_frame>
    <description>Measurable change in the curvature of penis</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Peyronie's Disease</condition>
  <arm_group>
    <arm_group_label>Single-Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Xiaflex® 0.58 mg, 2 injections separated by 1 to 3 days, repeated after 6 weeks for up to 4 treatment cycles.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Xiaflex® 0.58 mg</intervention_name>
    <description>0.25 mL injections.</description>
    <arm_group_label>Single-Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Willing and able to provide written informed consent to participate in the study.&#xD;
&#xD;
          2. Male aged ≥18 years old at screening.&#xD;
&#xD;
          3. Previously received Xiaflex® treatment and had a partial or complete response.&#xD;
&#xD;
               -  Partial response is defined as receiving ≤ 4 cycles of Xiaflex® and achieving a&#xD;
                  penile curvature of ≥ 15 degrees and &lt; 90 degrees.&#xD;
&#xD;
               -  Complete response is defined as receiving ≤ 4 cycles of Xiaflex® and achieving a&#xD;
                  penile curvature of &lt; 15 degrees.&#xD;
&#xD;
          4. Has a diagnosis of Peyronie's disease with a penile curvature of ≥ 30 and ≤ 90 degrees&#xD;
             at the screening visit.&#xD;
&#xD;
          5. Has a penile curvature of at ≥ 30 degrees in the dorsal, lateral, or dorsal/lateral&#xD;
             plane at the screening visit. It must be possible to delineate the single plane of&#xD;
             maximal curvature for evaluation during the study.&#xD;
&#xD;
          6. Able and willing to comply with restrictions where intercourse or any other sexual&#xD;
             activity is prohibited during each treatment cycle and for at least 2 weeks after each&#xD;
             injection cycle.&#xD;
&#xD;
          7. Able and willing to perform home modeling sessions between injection cycles.&#xD;
&#xD;
          8. Is in good health based on medical history evaluation and in the judgment of the&#xD;
             principal investigator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Has a penile curvature of &lt; 30 degrees or &gt; 90 degrees at the screening visit.&#xD;
&#xD;
          2. Previous allergic reaction to XIAFLEX®.&#xD;
&#xD;
          3. Has any of the following conditions:&#xD;
&#xD;
               -  Chordee in the presence or absence of hypospadias&#xD;
&#xD;
               -  Thrombosis of the dorsal penile artery and or vein&#xD;
&#xD;
               -  Infiltration by a benign or malignant mass resulting in penile curvature&#xD;
&#xD;
               -  Infiltration by an infectious agent, such as lymphogranuloma venereum&#xD;
&#xD;
               -  Ventral curvature from any cause&#xD;
&#xD;
               -  Presence of an active sexually transmitted disease&#xD;
&#xD;
               -  Known active hepatitis B or C&#xD;
&#xD;
               -  Known human immune deficiency virus (HIV)&#xD;
&#xD;
          4. Has previously undergone surgery for Peyronie's disease.&#xD;
&#xD;
          5. Has an erection which, in the opinion of the investigator, is insufficient to&#xD;
             accurately measure the subject's penile deformity after administration of the&#xD;
             prostaglandin E1 (PGE1), Trimix®, or similar erection inducing agent.&#xD;
&#xD;
          6. Has a calcified plaque that, in the opinion of the investigator, would prevent proper&#xD;
             administration of the study medication.&#xD;
&#xD;
          7. Has an isolated hourglass deformity of the penis.&#xD;
&#xD;
          8. Has a plaque causing a curvature of the penis located proximal to the base of the&#xD;
             penis where injection of local anesthetic would interfere with the injection of&#xD;
             Xiaflex®.&#xD;
&#xD;
          9. Has received intralesional or injection therapy for Peyronie's disease including&#xD;
             interferon, verapamil, or Xiaflex® &lt; 6 months prior to screening.&#xD;
&#xD;
         10. Has used antiplatelet or anti-coagulants (e.g. coumadin, Plavix®, Eliquis®, Effient®)&#xD;
             within 7 days prior to each Xiaflex® injection. Daily aspirin of 81 mg is acceptable.&#xD;
&#xD;
         11. Has had extracorporeal shock wave therapy (ESWT) for the correction of Peyronie's&#xD;
             disease within the 6 months prior to screening or plans to have ESWT at any time&#xD;
             during the study.&#xD;
&#xD;
         12. Has uncontrolled hypertension as determined by the investigator.&#xD;
&#xD;
         13. Has a recent history of stroke, bleeding, or other significant medical condition&#xD;
             which, in the investigator's opinion, would make the subject unsuitable for enrollment&#xD;
             in the study.&#xD;
&#xD;
         14. Has a planned surgical procedure during anticipated study participation.&#xD;
&#xD;
         15. Is unwilling or unable to cooperate with the requirements of the study including&#xD;
             completion of all scheduled study visits.&#xD;
&#xD;
         16. Has received investigational drug or treatment within 30 days of the first dose&#xD;
             Xiaflex®.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jed Kaminetsky, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Principal Investigator</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Harper Scott</last_name>
    <phone>212-480-3333</phone>
    <email>info@manhattanmedicalresearch.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Manhattan Medical Research Practice, PLLC</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Harper Scott</last_name>
      <phone>212-480-3333</phone>
      <email>info@manhattanmedicalresearch.com</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>December 5, 2018</last_update_submitted>
  <last_update_submitted_qc>December 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Recurrence</keyword>
  <keyword>Incomplete Response</keyword>
  <keyword>Worsening</keyword>
  <keyword>Curvature</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Penile Induration</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03767452
org study id: MMR032018
nct id: NCT03767452
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Subjects who have had an incomplete response to previous Xiaflex® will receive up to 4
      additional cycles of treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in the degree of penile curvature
time frame: From Screening up to 24 weeks
description: Measurable change in the curvature of penis
arm group label: Single-Arm
arm group type: Experimental
description: Xiaflex® 0.58 mg, 2 injections separated by 1 to 3 days, repeated after 6 weeks for up to 4 treatment cycles.
intervention type: Drug
intervention name: Xiaflex® 0.58 mg
description: 0.25 mL injections.
arm group label: Single-Arm
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jed Kaminetsky, MD
role: Principal Investigator
affiliation: Principal Investigator
last name: Harper Scott
phone: 212-480-3333
email: info@manhattanmedicalresearch.com
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Penile Induration
mesh term: Recurrence
sharing ipd: Undecided