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/NCT06018025</url>
    </required_header>
    <id_info>
      <org_study_id>Pro00113907</org_study_id>
      <nct_id>NCT06018025</nct_id>
    </id_info>
    <brief_title>NDPH Biomarker Study in Children and Adolescents</brief_title>
    <official_title>New Daily Persistent Headache (NDPH): Biomarker Study and Therapy in Children and Adolescents</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Duke University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>International Headache Society</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Duke 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>
        This study will recruit pediatric patients with NDPH (New Daily Persistent Headache),&#xD;
        characterize their headache in a standard manner, and treat the NDPH with standard&#xD;
        medications used for treatment of headaches in this population. Response to treatment with&#xD;
        CGRP blocking Ab medications will be evaluated. Biomarkers related to headache disorders will&#xD;
        be measured before and after treatment.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Subjects age 12-18 with diagnosis of NDPH (International Classification of Headache Disorders&#xD;
        D ICHD-3 criteria) will be recruited for the study. Consenting subjects will receive standard&#xD;
        headache care and treatment, including treatment with CGRP Blocking Ab medications. Blood&#xD;
        will be drawn before and after treatment, with assessment of Calcitonin Gene Related Peptid,&#xD;
        Pituitary Adenylate Cyclase Activating Peptid (PACAP), Brain derived Neurotrophic factor&#xD;
        (BDNF), Nerve Growth Factor (NGF), and Tumor Necrosis Factor alpha, and Vasointestinal peptic&#xD;
        (VIP) before and after treatment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">July 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">July 1, 2025</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>4 Months</target_duration>
    <primary_outcome>
      <measure>Change in Calcitonin Gene Related Peptide (CGRP) levels in blood</measure>
      <time_frame>baseline and 4 months</time_frame>
      <description>biomarker</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Pituitary Adenylate Cyclase-activating Peptide (PACAP) levels in blood</measure>
      <time_frame>baseline and 4 months</time_frame>
      <description>protein biomarker</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Brain derived Neurotrophic factor (BDNF) levels in blood</measure>
      <time_frame>baseline and 4 months</time_frame>
      <description>protein biomarker</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Nerve Growth Factor (NGF) levels in blood</measure>
      <time_frame>baseline and 4 months</time_frame>
      <description>protein biomarker</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Tumor Necrosis Factor alpha levels in blood</measure>
      <time_frame>baseline and 4 months</time_frame>
      <description>protein biomarker</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Vaso Intestinal peptide(VIP) levels in blood</measure>
      <time_frame>baseline and 4 months</time_frame>
      <description>protein biomarker</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Disability Scoring</measure>
      <time_frame>0 to 4 months</time_frame>
      <description>Changes in the Disability Scoring using the Pediatric Migraine Disability Assessment(PedMIDAS) will be recorded at the baseline visit (prior to first CGRP-AB treatment) and 4 months after receiving CGRP-AB treatment. Disability Grade ; 0 to 10. Little to none ; 11 to 30. Mild ; 31 to 50. Moderate ; Greater than 50. Severe</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Headache frequency</measure>
      <time_frame>0 to 4 months</time_frame>
      <description>Self-reported headache frequency will be recorded as the number of headaches in the prior month, collected at baseline and 4 months after last CGRP-AB treatment. The patients will be encouraged to keep a headache diary.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Screen for Child Anxiety Related Disorders (SCARED)</measure>
      <time_frame>at enrollment</time_frame>
      <description>41 items and 5 factors that parallel the DSM-IV classification of anxiety disorders. A total score of 0-9, normal or no anxiety; 10-18, mild to moderate anxiety; 19-29, moderate to severe anxiety; and 30-63, severe anxiety.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Health Questionnaire-9 modified for Adolescents administered after recruitment</measure>
      <time_frame>at enrollment</time_frame>
      <description>Scores of 0-4 points normal or minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression and 20-27 severe depression</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Headache Pain Intensity</measure>
      <time_frame>0 to 4 months</time_frame>
      <description>Average severity will be measured using a 10-point pain scale, where a higher score indicates greater pain.</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">150</enrollment>
    <condition>New Persistent Daily Headache</condition>
    <arm_group>
      <arm_group_label>NPDH (New Persistent Daily Headache)</arm_group_label>
      <description>Patients with new persistent daily headache (NDPH) ages 12-18 years will be recruited and consented by the study coordinator. Patients will be recruited from patients already established with the Duke Pediatric Neurology clinic with a diagnosis of NDPH, or after their initial visit to establish the diagnosis of NDPH through the Duke, pediatric neurology clinics, personal communication and networking, and through the Duke adult headache clinic.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Healthy (Normal) Controls</arm_group_label>
      <description>Children with normal development, aged 12-18 years, will be identified via the electronic health records of well-child visits in Duke Children's Hospital, community advertising and through networking with colleagues and friends.&#xD;
  Exclusion: 1) History of concussion or head injury 2) Psychiatric disorders 3) History of migraines or other headache disorder treated in the past 4) Known structural brain lesions (tumor, hydrocephalus, congenital anomalies)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Chronic Migraine</arm_group_label>
      <description>Patients between 12-18 yrs of age:&#xD;
  A) Headache (migraine-like or tension-type-like) on ≥15 days/month for &gt;3 months, and fulfilling criteria B and C, B) Occurring in a patient who has had at least five attacks fulfilling criteria B-D for 1.1 Migraine without aura and/or criteria B and C for 1.2 Migraine with aura C) On ≥8 days/month for &gt;3 months, fulfilling any of the following (1) criteria C and D for 1.1 Migraine without aura 2) criteria B and C for 1.2 Migraine with aura 3) believed by the patient to be migraine at onset and relieved by a triptan or ergot derivative D) Not better accounted for by another ICHD-3 diagnosis</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>CGRP antibody</intervention_name>
      <description>treatment with CGRP antibody for 4 months</description>
      <arm_group_label>Chronic Migraine</arm_group_label>
      <arm_group_label>NPDH (New Persistent Daily Headache)</arm_group_label>
    </intervention>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        whole blood, serum,&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          50 patients with NPDH age 12-18yrs 50 patients with chronic migraine age 12-18 yrs 50&#xD;
          normal controls age 12-18 yrs&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients between 12-18 yo with diagnosis of new daily persistent headache (ICHD-3&#xD;
               criteria) who have normal developmental history for age&#xD;
  &#xD;
            -  Subject and parent legal guardian able to communicate in English, understand and&#xD;
               consent to study&#xD;
  &#xD;
            -  Subject will to undergo monthly injections at home for treatment of NDPH&#xD;
  &#xD;
            -  Normal neuro imaging&#xD;
  &#xD;
            -  No prior treatment with CGRP blocking medications or botulinum toxin&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of Reynauds syndrome&#xD;
  &#xD;
            -  History of concussion or prior neurosurgery&#xD;
  &#xD;
            -  Any structural brain lesion including hydrocephalus, congenital anomalies (including&#xD;
               chiari malformation)&#xD;
  &#xD;
            -  History of psychiatric disorders&#xD;
  &#xD;
            -  History of any headache disorder (including migraine) prior to the diagnosis of NDPH&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Prior treatment with any CGRP blocking medication&#xD;
  &#xD;
            -  Treatment with Botulinum toxin injections previously&#xD;
  &#xD;
            -  Any other condition that in the opinion of the PI would interfere with the planned&#xD;
               study treatment&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Klaus Werner, MD</last_name>
      <phone>3157480357</phone>
      <email>klaus.werner@duke.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Carlene Moore, PhD</last_name>
      <phone>2053350947</phone>
      <email>carlene.moore@duke.edu</email>
    </overall_contact_backup>
    <reference>
      <citation>Greene KA, Gentile CP, Szperka CL, Yonker M, Gelfand AA, Grimes B, Irwin SL. Calcitonin Gene-Related Peptide Monoclonal Antibody Use for the Preventive Treatment of Refractory Headache Disorders in Adolescents. Pediatr Neurol. 2021 Jan;114:62-67. doi: 10.1016/j.pediatrneurol.2020.09.014. Epub 2020 Oct 5.</citation>
      <PMID>33232919</PMID>
    </reference>
    <reference>
      <citation>Demartini C, Francavilla M, Zanaboni AM, Facchetti S, De Icco R, Martinelli D, Allena M, Greco R, Tassorelli C. Biomarkers of Migraine: An Integrated Evaluation of Preclinical and Clinical Findings. Int J Mol Sci. 2023 Mar 10;24(6):5334. doi: 10.3390/ijms24065334.</citation>
      <PMID>36982428</PMID>
    </reference>
    <reference>
      <citation>Gelfand AA, Robbins MS, Szperka CL. New Daily Persistent Headache-A Start With an Uncertain End. JAMA Neurol. 2022 Aug 1;79(8):733-734. doi: 10.1001/jamaneurol.2022.1727. No abstract available.</citation>
      <PMID>35788252</PMID>
    </reference>
    <reference>
      <citation>Goadsby PJ. New daily persistent headache: a syndrome, not a discrete disorder. Headache. 2011 Apr;51(4):650-3. doi: 10.1111/j.1526-4610.2011.01872.x.</citation>
      <PMID>21457252</PMID>
    </reference>
    <reference>
      <citation>Peng KP, Rozen TD. Update in the understanding of new daily persistent headache. Cephalalgia. 2023 Feb;43(2):3331024221146314. doi: 10.1177/03331024221146314.</citation>
      <PMID>36759317</PMID>
    </reference>
    <reference>
      <citation>Gladstein J, Holden EW. Chronic daily headache in children and adolescents: a 2-year prospective study. Headache. 1996 Jun;36(6):349-51. doi: 10.1046/j.1526-4610.1996.3606349.x.</citation>
      <PMID>8707551</PMID>
    </reference>
    <reference>
      <citation>Hanci F, Kilinc YB, Kilinc E, Turay S, Dilek M, Kabakus N. Plasma levels of vasoactive neuropeptides in pediatric patients with migraine during attack and attack-free periods. Cephalalgia. 2021 Feb;41(2):166-175. doi: 10.1177/0333102420957588. Epub 2020 Sep 9.</citation>
      <PMID>32903061</PMID>
    </reference>
    <reference>
      <citation>Evers S. CGRP in Childhood and Adolescence Migraine: (Patho)physiological and Clinical Aspects. Curr Pain Headache Rep. 2022 Jun;26(6):475-480. doi: 10.1007/s11916-022-01047-5. Epub 2022 Mar 30.</citation>
      <PMID>35353359</PMID>
    </reference>
    <reference>
      <citation>Christensen CE, Ashina M, Amin FM. Calcitonin Gene-Related Peptide (CGRP) and Pituitary Adenylate Cyclase-Activating Polypeptide (PACAP) in Migraine Pathogenesis. Pharmaceuticals (Basel). 2022 Sep 27;15(10):1189. doi: 10.3390/ph15101189.</citation>
      <PMID>36297301</PMID>
    </reference>
    <reference>
      <citation>Vollesen ALH, Amin FM, Ashina M. Targeted Pituitary Adenylate Cyclase-Activating Peptide Therapies for Migraine. Neurotherapeutics. 2018 Apr;15(2):371-376. doi: 10.1007/s13311-017-0596-x.</citation>
      <PMID>29464574</PMID>
    </reference>
    <reference>
      <citation>Sarchielli P, Caproni S, Costa C, Szok D, Tajti J. Chapter 10: Biochemistry of Primary Headaches. Pathophysiology of Headaches 2015: 185-216.</citation>
    </reference>
    <reference>
      <citation>Ashina M, Terwindt GM, Al-Karagholi MA, de Boer I, Lee MJ, Hay DL, Schulte LH, Hadjikhani N, Sinclair AJ, Ashina H, Schwedt TJ, Goadsby PJ. Migraine: disease characterisation, biomarkers, and precision medicine. Lancet. 2021 Apr 17;397(10283):1496-1504. doi: 10.1016/S0140-6736(20)32162-0. Epub 2021 Mar 25.</citation>
      <PMID>33773610</PMID>
    </reference>
    <reference>
      <citation>Moyes C, Belaghi R, Webster RJ, Whitley N, Pohl D. Cognitive Behavioral Therapy for Children With Headaches: Will an App Do the Trick? J Child Neurol. 2023 Mar;38(3-4):169-177. doi: 10.1177/08830738231170067. Epub 2023 Apr 25.</citation>
      <PMID>37097885</PMID>
    </reference>
    <reference>
      <citation>McAbee GN, Morse AM, Assadi M. Pediatric Aspects of Headache Classification in the International Classification of Headache Disorders-3 (ICHD-3 beta version). Curr Pain Headache Rep. 2016 Jan;20(1):7. doi: 10.1007/s11916-015-0537-5.</citation>
      <PMID>26749046</PMID>
    </reference>
    <reference>
      <citation>Begasse de Dhaem O, Rizzoli P. Refractory Headaches. Semin Neurol. 2022 Aug;42(4):512-522. doi: 10.1055/s-0042-1757925. Epub 2022 Nov 2.</citation>
      <PMID>36323303</PMID>
    </reference>
    <reference>
      <citation>Nierenburg H, Newman LC. Update on New Daily Persistent Headache. Curr Treat Options Neurol. 2016 Jun;18(6):25. doi: 10.1007/s11940-016-0408-3.</citation>
      <PMID>27080086</PMID>
    </reference>
    <reference>
      <citation>Mack KJ. What incites new daily persistent headache in children? Pediatr Neurol. 2004 Aug;31(2):122-5. doi: 10.1016/j.pediatrneurol.2004.02.006.</citation>
      <PMID>15301832</PMID>
    </reference>
    <reference>
      <citation>Li D, Rozen TD. The clinical characteristics of new daily persistent headache. Cephalalgia. 2002 Feb;22(1):66-9. doi: 10.1046/j.1468-2982.2002.00326.x.</citation>
      <PMID>11993616</PMID>
    </reference>
    <reference>
      <citation>Baron EP, Rothner AD. New daily persistent headache in children and adolescents. Curr Neurol Neurosci Rep. 2010 Mar;10(2):127-32. doi: 10.1007/s11910-010-0097-3.</citation>
      <PMID>20425237</PMID>
    </reference>
    <reference>
      <citation>Mozafarihashjin M, Togha M, Ghorbani Z, Farbod A, Rafiee P, Martami F. Assessment of peripheral biomarkers potentially involved in episodic and chronic migraine: a case-control study with a focus on NGF, BDNF, VEGF, and PGE2. J Headache Pain. 2022 Jan 6;23(1):3. doi: 10.1186/s10194-021-01377-6.</citation>
      <PMID>34991456</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>NPDH CGRP PACAP BDNF NGF TNF-alpha VIP</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Headache</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Antibodies</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06018025
  org study id: Pro00113907
  nct id: NCT06018025
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  This study will recruit pediatric patients with NDPH (New Daily Persistent Headache),
        characterize their headache in a standard manner, and treat the NDPH with standard
        medications used for treatment of headaches in this population. Response to treatment with
        CGRP blocking Ab medications will be evaluated. Biomarkers related to headache disorders will
        be measured before and after treatment.
  Subjects age 12-18 with diagnosis of NDPH (International Classification of Headache Disorders
        D ICHD-3 criteria) will be recruited for the study. Consenting subjects will receive standard
        headache care and treatment, including treatment with CGRP Blocking Ab medications. Blood
        will be drawn before and after treatment, with assessment of Calcitonin Gene Related Peptid,
        Pituitary Adenylate Cyclase Activating Peptid (PACAP), Brain derived Neurotrophic factor
        (BDNF), Nerve Growth Factor (NGF), and Tumor Necrosis Factor alpha, and Vasointestinal peptic
        (VIP) before and after treatment.
  observational model: Cohort
  time perspective: Prospective
  measure: Change in Calcitonin Gene Related Peptide (CGRP) levels in blood
  time frame: baseline and 4 months
  description: biomarker
  measure: Change in Pituitary Adenylate Cyclase-activating Peptide (PACAP) levels in blood
  time frame: baseline and 4 months
  description: protein biomarker
  measure: Change in Brain derived Neurotrophic factor (BDNF) levels in blood
  time frame: baseline and 4 months
  description: protein biomarker
  measure: Change in Nerve Growth Factor (NGF) levels in blood
  time frame: baseline and 4 months
  description: protein biomarker
  measure: Change in Tumor Necrosis Factor alpha levels in blood
  time frame: baseline and 4 months
  description: protein biomarker
  measure: Change in Vaso Intestinal peptide(VIP) levels in blood
  time frame: baseline and 4 months
  description: protein biomarker
  measure: Disability Scoring
  time frame: 0 to 4 months
  description: Changes in the Disability Scoring using the Pediatric Migraine Disability Assessment(PedMIDAS) will be recorded at the baseline visit (prior to first CGRP-AB treatment) and 4 months after receiving CGRP-AB treatment. Disability Grade ; 0 to 10. Little to none ; 11 to 30. Mild ; 31 to 50. Moderate ; Greater than 50. Severe
  measure: Change in Headache frequency
  time frame: 0 to 4 months
  description: Self-reported headache frequency will be recorded as the number of headaches in the prior month, collected at baseline and 4 months after last CGRP-AB treatment. The patients will be encouraged to keep a headache diary.
  measure: Screen for Child Anxiety Related Disorders (SCARED)
  time frame: at enrollment
  description: 41 items and 5 factors that parallel the DSM-IV classification of anxiety disorders. A total score of 0-9, normal or no anxiety; 10-18, mild to moderate anxiety; 19-29, moderate to severe anxiety; and 30-63, severe anxiety.
  measure: Patient Health Questionnaire-9 modified for Adolescents administered after recruitment
  time frame: at enrollment
  description: Scores of 0-4 points normal or minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression and 20-27 severe depression
  measure: Change in Headache Pain Intensity
  time frame: 0 to 4 months
  description: Average severity will be measured using a 10-point pain scale, where a higher score indicates greater pain.
  arm group label: NPDH (New Persistent Daily Headache)
  description: Patients with new persistent daily headache (NDPH) ages 12-18 years will be recruited and consented by the study coordinator. Patients will be recruited from patients already established with the Duke Pediatric Neurology clinic with a diagnosis of NDPH, or after their initial visit to establish the diagnosis of NDPH through the Duke, pediatric neurology clinics, personal communication and networking, and through the Duke adult headache clinic.
  arm group label: Healthy (Normal) Controls
  description: Children with normal development, aged 12-18 years, will be identified via the electronic health records of well-child visits in Duke Children's Hospital, community advertising and through networking with colleagues and friends.
  Exclusion: 1) History of concussion or head injury 2) Psychiatric disorders 3) History of migraines or other headache disorder treated in the past 4) Known structural brain lesions (tumor, hydrocephalus, congenital anomalies)
  arm group label: Chronic Migraine
  description: Patients between 12-18 yrs of age:
  A) Headache (migraine-like or tension-type-like) on ≥15 days/month for >3 months, and fulfilling criteria B and C, B) Occurring in a patient who has had at least five attacks fulfilling criteria B-D for 1.1 Migraine without aura and/or criteria B and C for 1.2 Migraine with aura C) On ≥8 days/month for >3 months, fulfilling any of the following (1) criteria C and D for 1.1 Migraine without aura 2) criteria B and C for 1.2 Migraine with aura 3) believed by the patient to be migraine at onset and relieved by a triptan or ergot derivative D) Not better accounted for by another ICHD-3 diagnosis
  intervention type: Drug
  intervention name: CGRP antibody
  description: treatment with CGRP antibody for 4 months
  arm group label: Chronic Migraine
  arm group label: NPDH (New Persistent Daily Headache)
  whole blood, serum,
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 12 Years
  maximum age: 18 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Klaus Werner, MD
  phone: 3157480357
  email: klaus.werner@duke.edu
  last name: Carlene Moore, PhD
  phone: 2053350947
  email: carlene.moore@duke.edu
  citation: Greene KA, Gentile CP, Szperka CL, Yonker M, Gelfand AA, Grimes B, Irwin SL. Calcitonin Gene-Related Peptide Monoclonal Antibody Use for the Preventive Treatment of Refractory Headache Disorders in Adolescents. Pediatr Neurol. 2021 Jan;114:62-67. doi: 10.1016/j.pediatrneurol.2020.09.014. Epub 2020 Oct 5.
  PMID: 33232919
  citation: Demartini C, Francavilla M, Zanaboni AM, Facchetti S, De Icco R, Martinelli D, Allena M, Greco R, Tassorelli C. Biomarkers of Migraine: An Integrated Evaluation of Preclinical and Clinical Findings. Int J Mol Sci. 2023 Mar 10;24(6):5334. doi: 10.3390/ijms24065334.
  PMID: 36982428
  citation: Gelfand AA, Robbins MS, Szperka CL. New Daily Persistent Headache-A Start With an Uncertain End. JAMA Neurol. 2022 Aug 1;79(8):733-734. doi: 10.1001/jamaneurol.2022.1727. No abstract available.
  PMID: 35788252
  citation: Goadsby PJ. New daily persistent headache: a syndrome, not a discrete disorder. Headache. 2011 Apr;51(4):650-3. doi: 10.1111/j.1526-4610.2011.01872.x.
  PMID: 21457252
  citation: Peng KP, Rozen TD. Update in the understanding of new daily persistent headache. Cephalalgia. 2023 Feb;43(2):3331024221146314. doi: 10.1177/03331024221146314.
  PMID: 36759317
  citation: Gladstein J, Holden EW. Chronic daily headache in children and adolescents: a 2-year prospective study. Headache. 1996 Jun;36(6):349-51. doi: 10.1046/j.1526-4610.1996.3606349.x.
  PMID: 8707551
  citation: Hanci F, Kilinc YB, Kilinc E, Turay S, Dilek M, Kabakus N. Plasma levels of vasoactive neuropeptides in pediatric patients with migraine during attack and attack-free periods. Cephalalgia. 2021 Feb;41(2):166-175. doi: 10.1177/0333102420957588. Epub 2020 Sep 9.
  PMID: 32903061
  citation: Evers S. CGRP in Childhood and Adolescence Migraine: (Patho)physiological and Clinical Aspects. Curr Pain Headache Rep. 2022 Jun;26(6):475-480. doi: 10.1007/s11916-022-01047-5. Epub 2022 Mar 30.
  PMID: 35353359
  citation: Christensen CE, Ashina M, Amin FM. Calcitonin Gene-Related Peptide (CGRP) and Pituitary Adenylate Cyclase-Activating Polypeptide (PACAP) in Migraine Pathogenesis. Pharmaceuticals (Basel). 2022 Sep 27;15(10):1189. doi: 10.3390/ph15101189.
  PMID: 36297301
  citation: Vollesen ALH, Amin FM, Ashina M. Targeted Pituitary Adenylate Cyclase-Activating Peptide Therapies for Migraine. Neurotherapeutics. 2018 Apr;15(2):371-376. doi: 10.1007/s13311-017-0596-x.
  PMID: 29464574
  citation: Sarchielli P, Caproni S, Costa C, Szok D, Tajti J. Chapter 10: Biochemistry of Primary Headaches. Pathophysiology of Headaches 2015: 185-216.
  citation: Ashina M, Terwindt GM, Al-Karagholi MA, de Boer I, Lee MJ, Hay DL, Schulte LH, Hadjikhani N, Sinclair AJ, Ashina H, Schwedt TJ, Goadsby PJ. Migraine: disease characterisation, biomarkers, and precision medicine. Lancet. 2021 Apr 17;397(10283):1496-1504. doi: 10.1016/S0140-6736(20)32162-0. Epub 2021 Mar 25.
  PMID: 33773610
  citation: Moyes C, Belaghi R, Webster RJ, Whitley N, Pohl D. Cognitive Behavioral Therapy for Children With Headaches: Will an App Do the Trick? J Child Neurol. 2023 Mar;38(3-4):169-177. doi: 10.1177/08830738231170067. Epub 2023 Apr 25.
  PMID: 37097885
  citation: McAbee GN, Morse AM, Assadi M. Pediatric Aspects of Headache Classification in the International Classification of Headache Disorders-3 (ICHD-3 beta version). Curr Pain Headache Rep. 2016 Jan;20(1):7. doi: 10.1007/s11916-015-0537-5.
  PMID: 26749046
  citation: Begasse de Dhaem O, Rizzoli P. Refractory Headaches. Semin Neurol. 2022 Aug;42(4):512-522. doi: 10.1055/s-0042-1757925. Epub 2022 Nov 2.
  PMID: 36323303
  citation: Nierenburg H, Newman LC. Update on New Daily Persistent Headache. Curr Treat Options Neurol. 2016 Jun;18(6):25. doi: 10.1007/s11940-016-0408-3.
  PMID: 27080086
  citation: Mack KJ. What incites new daily persistent headache in children? Pediatr Neurol. 2004 Aug;31(2):122-5. doi: 10.1016/j.pediatrneurol.2004.02.006.
  PMID: 15301832
  citation: Li D, Rozen TD. The clinical characteristics of new daily persistent headache. Cephalalgia. 2002 Feb;22(1):66-9. doi: 10.1046/j.1468-2982.2002.00326.x.
  PMID: 11993616
  citation: Baron EP, Rothner AD. New daily persistent headache in children and adolescents. Curr Neurol Neurosci Rep. 2010 Mar;10(2):127-32. doi: 10.1007/s11910-010-0097-3.
  PMID: 20425237
  citation: Mozafarihashjin M, Togha M, Ghorbani Z, Farbod A, Rafiee P, Martami F. Assessment of peripheral biomarkers potentially involved in episodic and chronic migraine: a case-control study with a focus on NGF, BDNF, VEGF, and PGE2. J Headache Pain. 2022 Jan 6;23(1):3. doi: 10.1186/s10194-021-01377-6.
  PMID: 34991456
  responsible party type: Sponsor
  mesh term: Headache
  mesh term: Antibodies
  sharing ipd: No