<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/NCT03817554</url>
  </required_header>
  <id_info>
    <org_study_id>pramipexole</org_study_id>
    <nct_id>NCT03817554</nct_id>
  </id_info>
  <brief_title>Pramipexole for Restless Leg Syndrome in Peritoneal Dialysis Patients</brief_title>
  <official_title>A Randomized Controlled Trial of Pramipexole for Restless Leg Syndrome in Peritoneal Dialysis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dong Jie</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University First Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      A randomized, double-blind controlled Study from a single center to evaluate the effect and&#xD;
      safety of pramipexole on peritoneal dialysis patients with restless legs syndrome&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Peritoneal dialysis patients diagnosed with restless legs syndrome will be divided into&#xD;
      experiment group and control group, and will be prescribed with pramipexole and placebo&#xD;
      respectively.After 12 weeks, we will compare IRLSSG（International RLS Study Group Rating&#xD;
      Scale）、MOS（Medical Outcomes Study ）Sleeping Scale、Self-Rating Anxiety Scale and Self-Rating&#xD;
      Depression Scale before and after the prescription.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The recruitment of participants in the study was difficulty.&#xD;
  </why_stopped>
  <start_date type="Actual">July 1, 2019</start_date>
  <completion_date type="Actual">August 31, 2020</completion_date>
  <primary_completion_date type="Actual">August 31, 2020</primary_completion_date>
  <phase>Phase 4</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Absolute change in IRLSSG Score</measure>
    <time_frame>12 weeks</time_frame>
    <description>Absolute change in IRLS sum score will be defined as a change in IRLSSG from baseline to the end of treatment phase. The scale range from 0 to 40. The higher values represent a worse outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect on Sleep assessment Questionnaire</measure>
    <time_frame>12 weeks</time_frame>
    <description>The absolute change of Sleep assessment Questionnaire between baseline and the twelfth week.The scale range from 0 to 60. The higher values represent a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect on Quality of life (QoL) questionare</measure>
    <time_frame>12 weeks</time_frame>
    <description>The absolute change of QoL between baseline and the twelfth week. The scale range from 20 to 60. The higher values represent a worse outcome.The scale range from 36 to 162. The higher values represent a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect on self rating anxiety scale</measure>
    <time_frame>12 weeks</time_frame>
    <description>The absolute change of self rating anxiety between baseline and the twelfth week. The scale range from 35 to 85. The higher values represent a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect on depression self rating scale</measure>
    <time_frame>12 weeks</time_frame>
    <description>The absolute change of depression self rating between baseline and the twelfth week. The absolute change of self rating anxiety between baseline and the twelfth week. The scale range from 20 to 60. The higher values represent a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects on Blood pressure</measure>
    <time_frame>12 weeks</time_frame>
    <description>The absolute change of 24-hour ambulatory blood pressure monitoring between baseline and the twelfth week. Both systolic and diastolic pressures will be assessed during the study period.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Restless Legs Syndrome</condition>
  <arm_group>
    <arm_group_label>Treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Peritoneal dialysis patients diagnosed with restless legs syndrome will receive pramipexole.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Peritoneal dialysis patients diagnosed with restless legs syndrome will receive placebo.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pramipexole</intervention_name>
    <description>Pramipexole will be taken once daily in the evening 2 to 3 hours before bedtime. The starting dose of pramipexole is 0.125 mg/day. During the first 4 weeks, the daily dose could be increased by the treating physician in weekly intervals to 0.25, 0.50, or 0.75 mg/day, according to the Patient Global Impression scale (PGI) rating and overall tolerability of the drug. In the case of adverse events (AEs), the dose could be reduced to the previous dose step. During 5 to 12 weeks, the dose will keep constant.</description>
    <arm_group_label>Treatment group</arm_group_label>
    <other_name>Dopamine Agonist</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>Placebo will be taken once daily in the evening 2 to 3 hours before bedtime. The starting dose of placebo is 0.125 mg/day. During the first 4 weeks, the daily dose could be increased by the treating physician in weekly intervals to 0.25, 0.50, or 0.75 mg/day, according to the Patient Global Impression scale (PGI) rating and overall tolerability of the drug. In the case of adverse events (AEs), the dose could be reduced to the previous dose step. During 5 to 12 weeks, the dose will keep constant.</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Treatment group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. PD patients (aged ≥18 years) are dialyzed with lactate-buffered glucose dialysate,&#xD;
             using a twinbag connection system (Baxter Healthcare, Guangzhou, China).&#xD;
&#xD;
          2. For entry , all patients are required to meet all diagnositic criteria of the&#xD;
             International RLS Study Group (IRLSSG), to have a baseline total score &gt;15 on the&#xD;
             Study Group's International RLS Rating Scale (IRLS), and to have experienced RLS&#xD;
             symptoms at least 2-3 days per week throughout the perior 3 months.&#xD;
&#xD;
          3. Each patient should write informed consent.&#xD;
&#xD;
          4. All patients are required to be interviewed to the frequency required by the research&#xD;
             process.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with severe gastrointestinal illness can not tolerate oral drugs.&#xD;
&#xD;
          2. Patients who work on a shift schedule are not allowed to participate.&#xD;
&#xD;
          3. Women with childbearing potential are excluded for pregnancy, inadequate&#xD;
             contraception, or current breastfeeding of a child.&#xD;
&#xD;
          4. Patients are also excluded for current use (within 14 days before baseline) of&#xD;
             medications that might affect RLS symptoms, e.g., levodopa, dopamine agonists or&#xD;
             antagonists, hypnotics, lithium formulations, or antidepressants.&#xD;
&#xD;
          5. Patients with serum ferritin ≤200 ng/ml, or Hb &lt;110g/L, or Kt/V &lt;1.7 are excluded.&#xD;
&#xD;
          6. Patients with severe and unstable inflammation disease (active systemic infection,&#xD;
             acute cardiovascular disease, active liver disease, active connective tissue disorder,&#xD;
             ,and cancer within 1 year of radiotherapy and chemotherapy, )&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jie Dong</last_name>
    <role>Study Director</role>
    <affiliation>Peking Universiy First Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peking University First Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100034</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>November 28, 2021</last_update_submitted>
  <last_update_submitted_qc>November 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Peking University First Hospital</investigator_affiliation>
    <investigator_full_name>Dong Jie</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Pramipexole,</keyword>
  <keyword>Restless Leg Syndrome</keyword>
  <keyword>Peritoneal Dialysis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psychomotor Agitation</mesh_term>
    <mesh_term>Restless Legs Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dopamine</mesh_term>
    <mesh_term>Pramipexole</mesh_term>
    <mesh_term>Dopamine Agonists</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03817554
org study id: pramipexole
nct id: NCT03817554
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
A randomized, double-blind controlled Study from a single center to evaluate the effect and
      safety of pramipexole on peritoneal dialysis patients with restless legs syndrome
Peritoneal dialysis patients diagnosed with restless legs syndrome will be divided into
      experiment group and control group, and will be prescribed with pramipexole and placebo
      respectively.After 12 weeks, we will compare IRLSSG（International RLS Study Group Rating
      Scale）、MOS（Medical Outcomes Study ）Sleeping Scale、Self-Rating Anxiety Scale and Self-Rating
      Depression Scale before and after the prescription.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Absolute change in IRLSSG Score
time frame: 12 weeks
description: Absolute change in IRLS sum score will be defined as a change in IRLSSG from baseline to the end of treatment phase. The scale range from 0 to 40. The higher values represent a worse outcome.
measure: Effect on Sleep assessment Questionnaire
time frame: 12 weeks
description: The absolute change of Sleep assessment Questionnaire between baseline and the twelfth week.The scale range from 0 to 60. The higher values represent a worse outcome.
measure: Effect on Quality of life (QoL) questionare
time frame: 12 weeks
description: The absolute change of QoL between baseline and the twelfth week. The scale range from 20 to 60. The higher values represent a worse outcome.The scale range from 36 to 162. The higher values represent a worse outcome.
measure: Effect on self rating anxiety scale
time frame: 12 weeks
description: The absolute change of self rating anxiety between baseline and the twelfth week. The scale range from 35 to 85. The higher values represent a worse outcome.
measure: Effect on depression self rating scale
time frame: 12 weeks
description: The absolute change of depression self rating between baseline and the twelfth week. The absolute change of self rating anxiety between baseline and the twelfth week. The scale range from 20 to 60. The higher values represent a worse outcome.
measure: Effects on Blood pressure
time frame: 12 weeks
description: The absolute change of 24-hour ambulatory blood pressure monitoring between baseline and the twelfth week. Both systolic and diastolic pressures will be assessed during the study period.
arm group label: Treatment group
arm group type: Experimental
description: Peritoneal dialysis patients diagnosed with restless legs syndrome will receive pramipexole.
arm group label: Control group
arm group type: Placebo Comparator
description: Peritoneal dialysis patients diagnosed with restless legs syndrome will receive placebo.
intervention type: Drug
intervention name: Pramipexole
description: Pramipexole will be taken once daily in the evening 2 to 3 hours before bedtime. The starting dose of pramipexole is 0.125 mg/day. During the first 4 weeks, the daily dose could be increased by the treating physician in weekly intervals to 0.25, 0.50, or 0.75 mg/day, according to the Patient Global Impression scale (PGI) rating and overall tolerability of the drug. In the case of adverse events (AEs), the dose could be reduced to the previous dose step. During 5 to 12 weeks, the dose will keep constant.
arm group label: Treatment group
other name: Dopamine Agonist
intervention type: Other
intervention name: placebo
description: Placebo will be taken once daily in the evening 2 to 3 hours before bedtime. The starting dose of placebo is 0.125 mg/day. During the first 4 weeks, the daily dose could be increased by the treating physician in weekly intervals to 0.25, 0.50, or 0.75 mg/day, according to the Patient Global Impression scale (PGI) rating and overall tolerability of the drug. In the case of adverse events (AEs), the dose could be reduced to the previous dose step. During 5 to 12 weeks, the dose will keep constant.
arm group label: Control group
arm group label: Treatment group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jie Dong
role: Study Director
affiliation: Peking Universiy First Hospital
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Peking University First Hospital
investigator full name: Dong Jie
investigator title: Clinical Professor
mesh term: Psychomotor Agitation
mesh term: Restless Legs Syndrome
mesh term: Syndrome
mesh term: Dopamine
mesh term: Pramipexole
mesh term: Dopamine Agonists
sharing ipd: No