<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/NCT03244735</url>
  </required_header>
  <id_info>
    <org_study_id>CCHDiet</org_study_id>
    <nct_id>NCT03244735</nct_id>
  </id_info>
  <brief_title>Efficacy of Modified Atkins Ketogenic Diet in Chronic Cluster Headache: a Prospective Case Series</brief_title>
  <acronym>CCHD</acronym>
  <official_title>Efficacy of Modified Atkins Ketogenic Diet in Chronic Cluster Headache. A Prospective Case Series</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Roma La Sapienza</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Roma La Sapienza</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Atkins diet is a nutritional regimen characterized by ad libitum protein and fat intake, but&#xD;
      carbohydrate restriction. It is followed by millions of people around the word as a&#xD;
      life-style, but in the last years was proposed as a treatment for the epilepsy, by its&#xD;
      capacity to induce the state of ketosis.&#xD;
&#xD;
      Since Authors observed that ketosis could be also useful in migraine, and migraine shares&#xD;
      some pathophysiological features with cluster headache, The aim of the study is to test the&#xD;
      efficacy of Atkins diet in Cluster Headache by an open label one harm observational study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Atkins diet is a ketogenic high-fat, low-carbohydrate diet for long adopted as lifestyle&#xD;
      by people that dislike have an high carbohydrate intake. This nutritional life style seems to&#xD;
      account for more energy in the daily activity and an easy weight control. In the last years,&#xD;
      researchers showed that a modified Atkins diet (MAD) can be useful to treat drug resistant&#xD;
      epilepsy, maybe by the induction of ketogenesis.&#xD;
&#xD;
      Ketogenesis, ketone-body formation, is a physiologic phenomenon also observed in patients&#xD;
      following low-carbohydrate high fat diets. Different Authors evidenced a protective effect of&#xD;
      ketone bodies also on migraine that shares some pathophysiological features with cluster&#xD;
      headache (CH).&#xD;
&#xD;
      CH is the worst form of headache, also called as &quot;suicide headache&quot;; in particular its&#xD;
      unremitting form, called Chronic CH (CCH) is regarded as a clinical challenge for&#xD;
      neurologist, if refractory to pharmacological treatments. So far, no data are available about&#xD;
      a beneficial effect of ketogenesis in CH. However, the beta hydroxybutyrate (BHB) has a&#xD;
      chemical formula similar to gamma hydroxybutyrate (GHB) that has shown to be effective in CH.&#xD;
      Moreover, ketosis has also a beneficial effect on hypothalamic dysfunctions that are shared&#xD;
      by some form of epilepsy and CH.&#xD;
&#xD;
      Aim of this study is verify in an open label observational study if a MAD can be useful in&#xD;
      the treatment of CCH. In case of positive outcome, the results could be used as preliminary&#xD;
      data to design a double blind versus placebo study, to asses definitively if ketogenesis is&#xD;
      really able to prevent/avoid headache attacks in CH.&#xD;
&#xD;
      Methods: By the Italian branch of the Organization for the Understanding of Cluster Headache&#xD;
      (OUCH), there will be recruited CCH volunteers that accept to modify their diet according to&#xD;
      Atkins Diet for at least three months.&#xD;
&#xD;
      Headache attack frequency will be collected on specific headache-calendars and a comparison&#xD;
      between the pre-diet phase and the during-the-diet- phase will be performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">August 2017</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>Case series</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Attack frequency</measure>
    <time_frame>3 months</time_frame>
    <description>Reduction of at least 50% of number of attacks per month</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Chronic Cluster Headache</condition>
  <arm_group>
    <arm_group_label>Modified Atkins Diet (MAD)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CCH patients that follows at least 3 months of MAD</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Atkins diet</intervention_name>
    <description>A nutritional regimen characterized by high fat low carbohydrate intake.</description>
    <arm_group_label>Modified Atkins Diet (MAD)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of CCH (less than 30 consecutive days of attacks remission in the last year)&#xD;
&#xD;
          -  kept a headache diary for at least 1 month&#xD;
&#xD;
          -  CH onset before the age of 50&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  over consumption of acute pain-killers (triptan, analgesic, or ergotamine)&#xD;
&#xD;
          -  pregnancy or lactation&#xD;
&#xD;
          -  type I diabetes&#xD;
&#xD;
          -  serious organic or psychiatric disorders that the investigators judged as having the&#xD;
             potential to influence the trial evaluation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Francesco Pierelli, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Sapienza Univeristy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Policlinico Umberto I</name>
      <address>
        <city>Rome</city>
        <zip>00161</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Di Lorenzo C, Coppola G, Sirianni G, Rossi P, Pierelli F. O045. Cluster headache improvement during Ketogenic Diet. J Headache Pain. 2015 Dec;16(Suppl 1):A99. doi: 10.1186/1129-2377-16-S1-A99. No abstract available. Erratum In: J Headache Pain. 2017 Dec;18(1):11.</citation>
    <PMID>28132289</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 5, 2017</study_first_submitted>
  <study_first_submitted_qc>August 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>August 10, 2017</last_update_submitted>
  <last_update_submitted_qc>August 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Roma La Sapienza</investigator_affiliation>
    <investigator_full_name>Cherubino DI LORENZO</investigator_full_name>
    <investigator_title>Research Fellow</investigator_title>
  </responsible_party>
  <keyword>Ketogenic Diet</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cluster Headache</mesh_term>
    <mesh_term>Headache</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>We do not share data</ipd_description>
  </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/NCT03244735
org study id: CCHDiet
nct id: NCT03244735
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Atkins diet is a nutritional regimen characterized by ad libitum protein and fat intake, but
      carbohydrate restriction. It is followed by millions of people around the word as a
      life-style, but in the last years was proposed as a treatment for the epilepsy, by its
      capacity to induce the state of ketosis.

      Since Authors observed that ketosis could be also useful in migraine, and migraine shares
      some pathophysiological features with cluster headache, The aim of the study is to test the
      efficacy of Atkins diet in Cluster Headache by an open label one harm observational study.
The Atkins diet is a ketogenic high-fat, low-carbohydrate diet for long adopted as lifestyle
      by people that dislike have an high carbohydrate intake. This nutritional life style seems to
      account for more energy in the daily activity and an easy weight control. In the last years,
      researchers showed that a modified Atkins diet (MAD) can be useful to treat drug resistant
      epilepsy, maybe by the induction of ketogenesis.

      Ketogenesis, ketone-body formation, is a physiologic phenomenon also observed in patients
      following low-carbohydrate high fat diets. Different Authors evidenced a protective effect of
      ketone bodies also on migraine that shares some pathophysiological features with cluster
      headache (CH).

      CH is the worst form of headache, also called as "suicide headache"; in particular its
      unremitting form, called Chronic CH (CCH) is regarded as a clinical challenge for
      neurologist, if refractory to pharmacological treatments. So far, no data are available about
      a beneficial effect of ketogenesis in CH. However, the beta hydroxybutyrate (BHB) has a
      chemical formula similar to gamma hydroxybutyrate (GHB) that has shown to be effective in CH.
      Moreover, ketosis has also a beneficial effect on hypothalamic dysfunctions that are shared
      by some form of epilepsy and CH.

      Aim of this study is verify in an open label observational study if a MAD can be useful in
      the treatment of CCH. In case of positive outcome, the results could be used as preliminary
      data to design a double blind versus placebo study, to asses definitively if ketogenesis is
      really able to prevent/avoid headache attacks in CH.

      Methods: By the Italian branch of the Organization for the Understanding of Cluster Headache
      (OUCH), there will be recruited CCH volunteers that accept to modify their diet according to
      Atkins Diet for at least three months.

      Headache attack frequency will be collected on specific headache-calendars and a comparison
      between the pre-diet phase and the during-the-diet- phase will be performed.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Case series
primary purpose: Treatment
masking: None (Open Label)
measure: Attack frequency
time frame: 3 months
description: Reduction of at least 50% of number of attacks per month
arm group label: Modified Atkins Diet (MAD)
arm group type: Experimental
description: CCH patients that follows at least 3 months of MAD
intervention type: Other
intervention name: Atkins diet
description: A nutritional regimen characterized by high fat low carbohydrate intake.
arm group label: Modified Atkins Diet (MAD)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Francesco Pierelli, MD
role: Study Chair
affiliation: Sapienza Univeristy
facility: 
country: Italy
citation: Di Lorenzo C, Coppola G, Sirianni G, Rossi P, Pierelli F. O045. Cluster headache improvement during Ketogenic Diet. J Headache Pain. 2015 Dec;16(Suppl 1):A99. doi: 10.1186/1129-2377-16-S1-A99. No abstract available. Erratum In: J Headache Pain. 2017 Dec;18(1):11.
PMID: 28132289
responsible party type: Principal Investigator
investigator affiliation: University of Roma La Sapienza
investigator full name: Cherubino DI LORENZO
investigator title: Research Fellow
mesh term: Cluster Headache
mesh term: Headache
sharing ipd: No
ipd description: We do not share data