<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/NCT02211508</url>
  </required_header>
  <id_info>
    <org_study_id>NPT-301</org_study_id>
    <nct_id>NCT02211508</nct_id>
  </id_info>
  <brief_title>Prospective Evaluation of RINCE to Reduce Fibromyalgia Effects - 301</brief_title>
  <acronym>PERRFECT-301</acronym>
  <official_title>A Double-Blinded, Randomized, Sham-Controlled, Pivotal Study of the NeuroPoint Device for the Treatment of Pain Associated With Fibromyalgia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cerephex Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cerephex Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to test the safety and efficacy of a noninvasive cortical&#xD;
      electrostimulation therapy known as &quot;Reduced Impedance Noninvasive Cortical&#xD;
      Electrostimulation&quot; (RINCE) in the treatment of pain associated with fibromyalgia. Patients&#xD;
      who meet the 2010 American College of Rheumatology criteria for fibromyalgia will receive up&#xD;
      to 24 RINCE treatments delivered by a medical device called &quot;NeuroPoint&quot;. Approximately 200&#xD;
      fibromyalgia patients will be randomized into one of two study groups. One of these groups&#xD;
      will receive sham treatment, meaning they will receive no treatment at all, while the other&#xD;
      group will receive active RINCE treatment. The study's primary outcome measure will be the&#xD;
      difference between active and sham treatment groups in the mean change from baseline in&#xD;
      patients' weekly worst pain scores. The study's hypothesis is that there will be a difference&#xD;
      between treatment groups in primary outcome measure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Trial terminated Feb '15. Interim analysis results missed primary endpoint, intended signal not&#xD;
    delivered in Tx arm, sham results as expected. No safety issues.&#xD;
  </why_stopped>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <phase>N/A</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>Change from baseline in patients' 24-hour recall worst pain intensity</measure>
    <time_frame>Assessed at 12 weeks</time_frame>
    <description>The primary efficacy endpoint will be the contrast at 12 weeks versus Baseline in the (paired) mean weekly change in patients' self-reported daily (24-hour) recall worst pain intensity using an 11-point (0-10) numerical rating scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient self-reported Global Impression of Change</measure>
    <time_frame>Assessed at 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients in the treatment and sham groups whose average daily worst pain intensity decreased by at least 50%</measure>
    <time_frame>Assessed at 12 weeks</time_frame>
    <description>Worst pain intensity evaluated using an 11-point (0-10) numerical rating scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Revised Fibromyalgia Impact Questionnaire</measure>
    <time_frame>Assessed at 12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">236</enrollment>
  <condition>Fibromyalgia</condition>
  <arm_group>
    <arm_group_label>12-week RINCE</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>RINCE - active RINCE therapy involving 24 total treatment applications from NeuroPoint device</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham RINCE</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham RINCE - sham RINCE therapy involving 24 total sham applications from NeuroPoint device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>RINCE</intervention_name>
    <description>The NeuroPoint device is used to deliver repeat applications of RINCE therapy</description>
    <arm_group_label>12-week RINCE</arm_group_label>
    <arm_group_label>Sham RINCE</arm_group_label>
    <other_name>RINCE therapy</other_name>
    <other_name>RINCE therapy delivered by the NeuroPoint device</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient is male or female, 22 to 65 years of age, inclusive.&#xD;
&#xD;
          -  Patient has a diagnosis of primary fibromyalgia as defined by the 2010 American&#xD;
             College of Rheumatology Preliminary Diagnostic Criteria for fibromyalgia.&#xD;
&#xD;
          -  If female, is either not of childbearing potential or is willing to utilize specified&#xD;
             practices throughout the study to prevent becoming pregnant.&#xD;
&#xD;
          -  Patient is willing and able to refrain or withdraw from the following therapies for&#xD;
             the duration of the study: duloxetine, milnacipran, pregabalin, gabapentin,&#xD;
             naltrexone, sodium oxybate, and opiates.&#xD;
&#xD;
          -  Qualified patients with mild or moderate depression must be clinically stable, without&#xD;
             risk of suicidal ideation or behavior, and the dose of allowed anti-depressants should&#xD;
             have been stable for at least three months prior to the Baseline clinic visit.&#xD;
&#xD;
          -  Patient is willing and able to comply with all protocol-specified requirements.&#xD;
&#xD;
          -  Patient is capable of reading and understanding English and has provided written&#xD;
             informed consent to participate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patient suffers from one or more of clinically significant psychiatric condition&#xD;
             that could interfere with the patient's well-being or ability to comply with the&#xD;
             protocol.&#xD;
&#xD;
          -  Patient has a Beck Depression Inventory-II total score greater than 25 at either the&#xD;
             Screening visit or Baseline clinic visit.&#xD;
&#xD;
          -  The patient is at increased risk of suicide.&#xD;
&#xD;
          -  Patient is unable, unwilling or not advised to refrain from or discontinue prohibited&#xD;
             medications or treatments.&#xD;
&#xD;
          -  Patient has a diagnosis of, or is being treated for, systemic lupus erythematosus,&#xD;
             inflammatory arthritis, or other documented systemic autoimmune disorder, Parkinson's&#xD;
             disease, multiple sclerosis, or cancer (other than basal or squamous cell skin&#xD;
             cancer).&#xD;
&#xD;
          -  Patient has any other chronic pain condition that, in the Investigator's or Sponsor's&#xD;
             opinion, could interfere with the patient's assessment of his/her fibromyalgia status.&#xD;
&#xD;
          -  Patient has a history of severe, refractory or uncontrolled migraine headaches,&#xD;
             seizure disorder or clinically significant cognitive dysfunction.&#xD;
&#xD;
          -  Patient is pregnant or planning to become pregnant within the next 6 months.&#xD;
&#xD;
          -  Patient has a body mass index greater than 40 at the Screening visit.&#xD;
&#xD;
          -  Patient has a history of cranial electrical stimulation or transcutaneous magnetic&#xD;
             stimulation within 2 years of screening, or electroconvulsive therapy within 5 years&#xD;
             of screening.&#xD;
&#xD;
          -  Patient has a metal implant at or above the level of the 7th cervical vertebra, a&#xD;
             cardiac pacemaker or defibrillator, or vagus nerve stimulator.&#xD;
&#xD;
          -  Any recent surgery or anticipated need for surgery that might confound results or&#xD;
             interfere with patient's ability to comply with the protocol.&#xD;
&#xD;
          -  Myocardial infarction during the 12 months prior to screening, uncontrolled&#xD;
             hypertension, active cardiac disease, clinically significant cardiac rhythm or&#xD;
             conduction abnormality, or anticipation of bypass or other cardiac surgery within the&#xD;
             next 12 months.&#xD;
&#xD;
          -  Current systemic infection (e.g., HIV, hepatitis B or C; Lyme disease).&#xD;
&#xD;
          -  Patient is using opiates on a regular or frequent basis.&#xD;
&#xD;
          -  Pending or current litigation or disability claim (including Workman's Compensation).&#xD;
&#xD;
          -  History of significant alcohol and/or drug abuse or dependency within preceding 5&#xD;
             years, or a positive result on the screening (or subsequent) drug screen indicating&#xD;
             use of an illicit substance.&#xD;
&#xD;
          -  Patient has participated in an investigational study of a therapeutic treatment within&#xD;
             90 days prior to Screening visit or is currently participating in another clinical&#xD;
             trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>R. Michael Gendreau, MD PhD</last_name>
    <role>Study Director</role>
    <affiliation>Cerephex Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Achieve Clinical Research, LLC</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Premier Research</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurovations</name>
      <address>
        <city>Napa</city>
        <state>California</state>
        <zip>94558</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Superior Research LLC</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95825</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Artemis Institute for Clinical Research</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Avail Clinical Research</name>
      <address>
        <city>Deland</city>
        <state>Florida</state>
        <zip>32720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Compass Research LLC</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chicago Research Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60634</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michigan Head Pain &amp; Neurological Institute</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fieve Clinical Research</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10168</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Upstate Clinical Research Associates</name>
      <address>
        <city>Williamsville</city>
        <state>New York</state>
        <zip>14221</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Cincinnati College of Medicine</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunstone Medical Research</name>
      <address>
        <city>Medford</city>
        <state>Oregon</state>
        <zip>97504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Omega Medical Research</name>
      <address>
        <city>Warwick</city>
        <state>Rhode Island</state>
        <zip>02886</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fatigue Consultation Clinic</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Clinical Research</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Hargrove JB, Bennett RM, Simons DG, Smith SJ, Nagpal S, Deering DE. A randomized placebo-controlled study of noninvasive cortical electrostimulation in the treatment of fibromyalgia patients. Pain Med. 2012 Jan;13(1):115-24. doi: 10.1111/j.1526-4637.2011.01292.x.</citation>
    <PMID>22233397</PMID>
  </reference>
  <reference>
    <citation>Hargrove JB, Bennett RM, Clauw DJ. Long-term outcomes in fibromyalgia patients treated with noninvasive cortical electrostimulation. Arch Phys Med Rehabil. 2012 Oct;93(10):1868-71. doi: 10.1016/j.apmr.2012.04.006. Epub 2012 Apr 21.</citation>
    <PMID>22525670</PMID>
  </reference>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <disposition_first_submitted>July 27, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>July 27, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">August 14, 2015</disposition_first_posted>
  <last_update_submitted>August 5, 2016</last_update_submitted>
  <last_update_submitted_qc>August 5, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 9, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>fibromyalgia</keyword>
  <keyword>pain</keyword>
  <keyword>stimulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibromyalgia</mesh_term>
    <mesh_term>Myofascial Pain Syndromes</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT02211508
org study id: NPT-301
nct id: NCT02211508
lead sponsor: 
has dmc: No
The purpose of this study is to test the safety and efficacy of a noninvasive cortical
      electrostimulation therapy known as "Reduced Impedance Noninvasive Cortical
      Electrostimulation" (RINCE) in the treatment of pain associated with fibromyalgia. Patients
      who meet the 2010 American College of Rheumatology criteria for fibromyalgia will receive up
      to 24 RINCE treatments delivered by a medical device called "NeuroPoint". Approximately 200
      fibromyalgia patients will be randomized into one of two study groups. One of these groups
      will receive sham treatment, meaning they will receive no treatment at all, while the other
      group will receive active RINCE treatment. The study's primary outcome measure will be the
      difference between active and sham treatment groups in the mean change from baseline in
      patients' weekly worst pain scores. The study's hypothesis is that there will be a difference
      between treatment groups in primary outcome measure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Change from baseline in patients' 24-hour recall worst pain intensity
time frame: Assessed at 12 weeks
description: The primary efficacy endpoint will be the contrast at 12 weeks versus Baseline in the (paired) mean weekly change in patients' self-reported daily (24-hour) recall worst pain intensity using an 11-point (0-10) numerical rating scale.
measure: Patient self-reported Global Impression of Change
time frame: Assessed at 12 weeks
measure: Proportion of patients in the treatment and sham groups whose average daily worst pain intensity decreased by at least 50%
time frame: Assessed at 12 weeks
description: Worst pain intensity evaluated using an 11-point (0-10) numerical rating scale.
measure: Change from baseline in Revised Fibromyalgia Impact Questionnaire
time frame: Assessed at 12 weeks
arm group label: 12-week RINCE
arm group type: Active Comparator
description: RINCE - active RINCE therapy involving 24 total treatment applications from NeuroPoint device
arm group label: Sham RINCE
arm group type: Sham Comparator
description: Sham RINCE - sham RINCE therapy involving 24 total sham applications from NeuroPoint device
intervention type: Device
intervention name: RINCE
description: The NeuroPoint device is used to deliver repeat applications of RINCE therapy
arm group label: 12-week RINCE
arm group label: Sham RINCE
other name: RINCE therapy
other name: RINCE therapy delivered by the NeuroPoint device
criteria: 
gender: All
minimum age: 22 Years
maximum age: 65 Years
healthy volunteers: No
last name: R. Michael Gendreau, MD PhD
role: Study Director
affiliation: Cerephex Corporation
facility: 
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country: United States
citation: Hargrove JB, Bennett RM, Simons DG, Smith SJ, Nagpal S, Deering DE. A randomized placebo-controlled study of noninvasive cortical electrostimulation in the treatment of fibromyalgia patients. Pain Med. 2012 Jan;13(1):115-24. doi: 10.1111/j.1526-4637.2011.01292.x.
PMID: 22233397
citation: Hargrove JB, Bennett RM, Clauw DJ. Long-term outcomes in fibromyalgia patients treated with noninvasive cortical electrostimulation. Arch Phys Med Rehabil. 2012 Oct;93(10):1868-71. doi: 10.1016/j.apmr.2012.04.006. Epub 2012 Apr 21.
PMID: 22525670
responsible party type: Sponsor
mesh term: Fibromyalgia
mesh term: Myofascial Pain Syndromes