<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/NCT03791515</url>
  </required_header>
  <id_info>
    <org_study_id>H-18011477</org_study_id>
    <nct_id>NCT03791515</nct_id>
  </id_info>
  <brief_title>Clinical Characteristics and Pathophysiology of Post-Traumatic Headache</brief_title>
  <official_title>Clinical Characteristics and Pathophysiology of Post-Traumatic Headache</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Danish Headache Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Danish Headache Center</source>
  <oversight_info>
    <has_dmc>Yes</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>
      To better understand the clinical characteristics and complex pathophysiological events that&#xD;
      constitute persistent post-traumatic headache (PPTH) and to identify possible calcitonin&#xD;
      gene-related peptide (CGRP) hypersensitivity in PPTH patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The present project will embark upon identifying novel PTH-specific biomarkers by&#xD;
      incorporating a plethora of scientific approaches. First, clinical biomarkers will be&#xD;
      assessed by deep phenotyping of clinical characteristics and associated comorbidities using a&#xD;
      semi-structured interview and multiple validated questionnaires. Second, biochemical&#xD;
      biomarkers will be determined by plasma levels measurements of blood markers for headache&#xD;
      hypersensitivity and neuronal/axonal damage. Third, imaging biomarkers will be established by&#xD;
      magnetic resonance imaging (MRI) to assess structural and functional changes in the brain.&#xD;
      Lastly, molecular biomarkers will be identified by examining whether intravenous infusion of&#xD;
      calcitonin gene-related peptide (CGRP) provokes headache attacks mimicking the usual headache&#xD;
      phenotype in subjects with PTH. This would determine whether PTH patients exhibit&#xD;
      hypersensitivity to CGRP (molecular biomarker) and advance our understanding of the complex&#xD;
      pathophysiological events that constitute the headache phenotypes in PTH sufferers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 26, 2018</start_date>
  <completion_date type="Actual">December 1, 2019</completion_date>
  <primary_completion_date type="Actual">December 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>100 patients with PPTH and 100 healthy controls will undergo a deep phenotyping of clinical characteristics and associated comorbidities. This is followed by a single MRI-session for all subjects.&#xD;
Lastly, the 30 patients with PPTH will participate in a randomized, double-blind, placebo-controlled, 2-way crossover study. These patients will be allocated to receive intravenous infusion of CGRP or placebo (isotonic saline) over 20 minutes on 2 study days.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Headache Characteristics</measure>
    <time_frame>50 minutes</time_frame>
    <description>Headache characteristics will be assessed using a semi-structured interview.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Headache Characteristics</measure>
    <time_frame>10 minutes</time_frame>
    <description>Headache characteristics will be assessed using Headache Under-Response to Treatment Index (HURT-Index) questionnaire. The total score ranges from 0 to 24 with a higher score indicating a lower effectiveness of intervention against headache.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cognitive Function</measure>
    <time_frame>10 minutes</time_frame>
    <description>Cognitive function will be assessed using Montreal Cognitive Assessment (MoCA) questionnaire. The total score ranges from 0 to 30 points. The MoCA is divided into 7 subscores: visuospatial/executive (5 points); naming (3 points); memory (5 points for delayed recall); attention (6 points); language (3 points); abstraction (2 points); and orientation (6 points). One point is added if the subject has ≤12 years of education. A total of 30 points may be given. A score ≤25 indicates some degree of cognitive impairment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Depression</measure>
    <time_frame>10 minutes</time_frame>
    <description>Depression will be assessed using Hospital Anxiety and Depression Scale (HADS) questionnaire. The total score ranges from 0-21.&#xD;
A score of 0-7 points is regarded as being in the normal range. A score of 8-10 points is suggestive of a depressive state (borderline abnormal).&#xD;
A score of 11-21 points indicates a probable presence of a depressive state (abnormal).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety</measure>
    <time_frame>10 minutes</time_frame>
    <description>Anxiety will be assessed using Hospital Anxiety and Depression Scale (HADS) questionnaire.&#xD;
The total score ranges from 0-21. A score of 0-7 points is regarded as being in the normal range. A score of 8-10 points is suggestive of a state of anxiety (borderline abnormal).&#xD;
A score of 11-21 points indicates a probable presence of an anxiety disorder (abnormal).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Allodynia</measure>
    <time_frame>10 minutes</time_frame>
    <description>Allodynia will be assessed using Allodynia Symptom Checklist (ASC-12) questionnaire. The total score ranges from 0-24 points.&#xD;
A score of 0-2 suggests no allodynia. A score of 3-5 suggests mild allodynia. A score of 6-8 suggests moderate allodynia. A score of 9 or more suggests severe allodynia.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-Traumatic Stress Disorder</measure>
    <time_frame>10 minutes</time_frame>
    <description>Post-traumatic stress disorder will be assessed using Harvard Trauma Questionnaire (HTQ). The total score ranges from 16-64. The total score is divided with 16 and a clinical cut-off score of 2.5 is set to be indicative of PTSD.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of Sleep: Pittsburgh Sleep Quality Index (PSQ-I)</measure>
    <time_frame>10 minutes</time_frame>
    <description>Quality of Sleep will be assessed using Pittsburgh Sleep Quality Index (PSQ-I). The measure consists of 19 individual items, creating 7 components that produce one global score. The total PSQ-I score ranges from 0 to 21 with lower scores indicating a healthier sleep quality.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Muscle Tenderness</measure>
    <time_frame>10 minutes</time_frame>
    <description>Muscle tenderness will be assessed using Total Tenderness Score (TTS). The total score ranges from 0-48 with higher scores indicating a higher degree of muscle tenderness.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pressure Pain Threshold</measure>
    <time_frame>10 minutes</time_frame>
    <description>Pressure Pain Threshold will be assessed using an Algometer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cortical Density</measure>
    <time_frame>10 minutes</time_frame>
    <description>Cortical density will be assessed using Voxel-Based Morphometry.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cortical Thickness</measure>
    <time_frame>10 minutes</time_frame>
    <description>Cortical thickness will be assessed using Surface-Based Morphometry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number and Location of Microhemorrhages</measure>
    <time_frame>6 minutes</time_frame>
    <description>The number and location of microhemorrhages will be assessed using Susceptibility-Weighted Imaging.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>White Matter Structural Fiber Integrity</measure>
    <time_frame>10 minutes</time_frame>
    <description>The white matter structural fiber integrity will be assessed using Diffusion Tensor Imaging</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number and Location of White Matter Lesions</measure>
    <time_frame>6 minutes</time_frame>
    <description>The number and location of white matter lesions will be assessed using T2-weighted Fluid-Attenuated Inversion Recovery.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cerebral Blood Flow</measure>
    <time_frame>7 minutes</time_frame>
    <description>Cerebral blood flow will be assessed using arterial spin labelling (ASL).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Brain Network Functional Connectivity</measure>
    <time_frame>11 minutes</time_frame>
    <description>Brain network functional connectivity will be assessed using blood oxygen level-dependent functional magnetic resonance imaging.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of Headache Exacerbation with Migraine-Like Features</measure>
    <time_frame>60 minutes</time_frame>
    <description>Migraine-like features are defined as headache fulfilling at least two of the following four characteristics:&#xD;
Unilateral location&#xD;
Pulsating quality&#xD;
Moderate or severe pain intensity&#xD;
Aggravation by or causing avoidance of routine physical activity (e.g. walking or climbing stairs)&#xD;
And during headache at least one of the following must be fulfilled:&#xD;
Nausea and/or vomiting&#xD;
Photophobia and phonophobia&#xD;
Headache mimicking the usual exacerbated headache with migraine-like features&#xD;
If the participant fulfills these criteria at baseline, then incidence of exacerbated headache with migraine-like features is defined as:&#xD;
- An increase in headache intensity combined with an increase in the degree nausea and/or photophobia and phonophobia (based on a mild / moderate / severe scale)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Headache Area under the Curve</measure>
    <time_frame>12 hours</time_frame>
    <description>Headache area under the curve is defined as headache intensity x duration up to 12 h after CGRP infusion</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Maximum Headache</measure>
    <time_frame>12 hours</time_frame>
    <description>Time to maximum headache score on CGRP day compared to placebo day will be assessed using a headache questionnaire</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Post-Traumatic Headache</condition>
  <condition>Concussion, Mild</condition>
  <arm_group>
    <arm_group_label>Calcitonin Gene-Related Peptide (CGRP)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>30 patients with PPTH will be allocated to receive intravenous infusion of 1.5 µg/min calcitonin-gene related peptide over 20 minutes&#xD;
Other Name: CGRP</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>30 patients with PPTH wil be allocated to receive 40 mL Placebo (isotonic saline) over 20 minutes.&#xD;
Other Name: Isotonic Saline</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Calcitonin Gene-Related Peptide</intervention_name>
    <description>A randomized clinical trial with a double-blinded, randomized, placebo-controlled crossover design. 30 PPTH patients will be included. All participants will receive continuous intravenous infusion of 1.5 µg/min CGRP over 20 min.&#xD;
The following variables will be recorded before, during and after infusion (every 10 min over 60 min): headache intensity on a verbal rating scale from 0 to 10 and headache characteristics. At 90 min, participants will be discharged and instructed to fill out a headache diary for 24 hours from start of infusion.</description>
    <arm_group_label>Calcitonin Gene-Related Peptide (CGRP)</arm_group_label>
    <other_name>CGRP</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>A randomized clinical trial with a double-blinded, randomized, placebo-controlled crossover design. 30 PPTH patients will be included. All participants will receive continuous intravenous infusion of 40 mL placebo (isotonic saline) over 20 min.&#xD;
The following variables will be recorded before, during and after infusion (every 10 min over 60 min): headache intensity on a verbal rating scale from 0 to 10 and headache characteristics. At 90 min, participants will be discharged and instructed to fill out a headache diary for 24 hours from start of infusion.</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Isotonic Saline</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for PPTH patients:&#xD;
&#xD;
          -  18-65 years of age&#xD;
&#xD;
          -  Subject has PPTH in accordance with the diagnostic criteria of the International&#xD;
             Headache Society (IHS)&#xD;
&#xD;
          -  Concussion (mild traumatic brain injury) occured &gt; 12 months ago&#xD;
&#xD;
          -  Subject, who are fertile women, must be on safe contraceptives&#xD;
&#xD;
        Exclusion Criteria for PPTH patients:&#xD;
&#xD;
          -  Pre-trauma existing primary headache disorder (maximum 1 day/per month with&#xD;
             tension-type headache) and medication-overuse headache&#xD;
&#xD;
          -  &gt; 1 episode with a sustained concussion&#xD;
&#xD;
          -  Whiplash&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Cardiovascular disease of any kind&#xD;
&#xD;
          -  Hypertension on the experimental day&#xD;
&#xD;
          -  Hypotension on the experimental day&#xD;
&#xD;
          -  Pre-trauma existing psychiatric disorder of any kind - unless well-regulated&#xD;
&#xD;
          -  Any anamnestic or clinical signs of any kind deemed relevant for the study by the&#xD;
             physician examining the subject&#xD;
&#xD;
          -  Any MRI contraindication and a wish of not being informed about unexpected MRI changes&#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>Henrik Schytz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Associate Professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Danish Headache Center</name>
      <address>
        <city>Glostrup</city>
        <zip>2600</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>July 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 2, 2019</study_first_posted>
  <last_update_submitted>January 27, 2020</last_update_submitted>
  <last_update_submitted_qc>January 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Danish Headache Center</investigator_affiliation>
    <investigator_full_name>Henrik Schytz</investigator_full_name>
    <investigator_title>Associate Professor of Neurology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Post-Traumatic Headache</mesh_term>
    <mesh_term>Brain Concussion</mesh_term>
    <mesh_term>Headache</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcitonin</mesh_term>
    <mesh_term>Salmon calcitonin</mesh_term>
    <mesh_term>Calcitonin Gene-Related Peptide</mesh_term>
    <mesh_term>Katacalcin</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/NCT03791515
org study id: H-18011477
nct id: NCT03791515
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To better understand the clinical characteristics and complex pathophysiological events that
      constitute persistent post-traumatic headache (PPTH) and to identify possible calcitonin
      gene-related peptide (CGRP) hypersensitivity in PPTH patients.
The present project will embark upon identifying novel PTH-specific biomarkers by
      incorporating a plethora of scientific approaches. First, clinical biomarkers will be
      assessed by deep phenotyping of clinical characteristics and associated comorbidities using a
      semi-structured interview and multiple validated questionnaires. Second, biochemical
      biomarkers will be determined by plasma levels measurements of blood markers for headache
      hypersensitivity and neuronal/axonal damage. Third, imaging biomarkers will be established by
      magnetic resonance imaging (MRI) to assess structural and functional changes in the brain.
      Lastly, molecular biomarkers will be identified by examining whether intravenous infusion of
      calcitonin gene-related peptide (CGRP) provokes headache attacks mimicking the usual headache
      phenotype in subjects with PTH. This would determine whether PTH patients exhibit
      hypersensitivity to CGRP (molecular biomarker) and advance our understanding of the complex
      pathophysiological events that constitute the headache phenotypes in PTH sufferers.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: 100 patients with PPTH and 100 healthy controls will undergo a deep phenotyping of clinical characteristics and associated comorbidities. This is followed by a single MRI-session for all subjects.
Lastly, the 30 patients with PPTH will participate in a randomized, double-blind, placebo-controlled, 2-way crossover study. These patients will be allocated to receive intravenous infusion of CGRP or placebo (isotonic saline) over 20 minutes on 2 study days.
primary purpose: Other
masking: None (Open Label)
measure: Headache Characteristics
time frame: 50 minutes
description: Headache characteristics will be assessed using a semi-structured interview.
measure: Headache Characteristics
time frame: 10 minutes
description: Headache characteristics will be assessed using Headache Under-Response to Treatment Index (HURT-Index) questionnaire. The total score ranges from 0 to 24 with a higher score indicating a lower effectiveness of intervention against headache.
measure: Cognitive Function
time frame: 10 minutes
description: Cognitive function will be assessed using Montreal Cognitive Assessment (MoCA) questionnaire. The total score ranges from 0 to 30 points. The MoCA is divided into 7 subscores: visuospatial/executive (5 points); naming (3 points); memory (5 points for delayed recall); attention (6 points); language (3 points); abstraction (2 points); and orientation (6 points). One point is added if the subject has ≤12 years of education. A total of 30 points may be given. A score ≤25 indicates some degree of cognitive impairment.
measure: Depression
time frame: 10 minutes
description: Depression will be assessed using Hospital Anxiety and Depression Scale (HADS) questionnaire. The total score ranges from 0-21.
A score of 0-7 points is regarded as being in the normal range. A score of 8-10 points is suggestive of a depressive state (borderline abnormal).
A score of 11-21 points indicates a probable presence of a depressive state (abnormal).
measure: Anxiety
time frame: 10 minutes
description: Anxiety will be assessed using Hospital Anxiety and Depression Scale (HADS) questionnaire.
The total score ranges from 0-21. A score of 0-7 points is regarded as being in the normal range. A score of 8-10 points is suggestive of a state of anxiety (borderline abnormal).
A score of 11-21 points indicates a probable presence of an anxiety disorder (abnormal).
measure: Allodynia
time frame: 10 minutes
description: Allodynia will be assessed using Allodynia Symptom Checklist (ASC-12) questionnaire. The total score ranges from 0-24 points.
A score of 0-2 suggests no allodynia. A score of 3-5 suggests mild allodynia. A score of 6-8 suggests moderate allodynia. A score of 9 or more suggests severe allodynia.
measure: Post-Traumatic Stress Disorder
time frame: 10 minutes
description: Post-traumatic stress disorder will be assessed using Harvard Trauma Questionnaire (HTQ). The total score ranges from 16-64. The total score is divided with 16 and a clinical cut-off score of 2.5 is set to be indicative of PTSD.
measure: Quality of Sleep: Pittsburgh Sleep Quality Index (PSQ-I)
time frame: 10 minutes
description: Quality of Sleep will be assessed using Pittsburgh Sleep Quality Index (PSQ-I). The measure consists of 19 individual items, creating 7 components that produce one global score. The total PSQ-I score ranges from 0 to 21 with lower scores indicating a healthier sleep quality.
measure: Muscle Tenderness
time frame: 10 minutes
description: Muscle tenderness will be assessed using Total Tenderness Score (TTS). The total score ranges from 0-48 with higher scores indicating a higher degree of muscle tenderness.
measure: Pressure Pain Threshold
time frame: 10 minutes
description: Pressure Pain Threshold will be assessed using an Algometer.
measure: Cortical Density
time frame: 10 minutes
description: Cortical density will be assessed using Voxel-Based Morphometry.
measure: Cortical Thickness
time frame: 10 minutes
description: Cortical thickness will be assessed using Surface-Based Morphometry
measure: Number and Location of Microhemorrhages
time frame: 6 minutes
description: The number and location of microhemorrhages will be assessed using Susceptibility-Weighted Imaging.
measure: White Matter Structural Fiber Integrity
time frame: 10 minutes
description: The white matter structural fiber integrity will be assessed using Diffusion Tensor Imaging
measure: Number and Location of White Matter Lesions
time frame: 6 minutes
description: The number and location of white matter lesions will be assessed using T2-weighted Fluid-Attenuated Inversion Recovery.
measure: Cerebral Blood Flow
time frame: 7 minutes
description: Cerebral blood flow will be assessed using arterial spin labelling (ASL).
measure: Brain Network Functional Connectivity
time frame: 11 minutes
description: Brain network functional connectivity will be assessed using blood oxygen level-dependent functional magnetic resonance imaging.
measure: Incidence of Headache Exacerbation with Migraine-Like Features
time frame: 60 minutes
description: Migraine-like features are defined as headache fulfilling at least two of the following four characteristics:
Unilateral location
Pulsating quality
Moderate or severe pain intensity
Aggravation by or causing avoidance of routine physical activity (e.g. walking or climbing stairs)
And during headache at least one of the following must be fulfilled:
Nausea and/or vomiting
Photophobia and phonophobia
Headache mimicking the usual exacerbated headache with migraine-like features
If the participant fulfills these criteria at baseline, then incidence of exacerbated headache with migraine-like features is defined as:
- An increase in headache intensity combined with an increase in the degree nausea and/or photophobia and phonophobia (based on a mild / moderate / severe scale)
measure: Headache Area under the Curve
time frame: 12 hours
description: Headache area under the curve is defined as headache intensity x duration up to 12 h after CGRP infusion
measure: Time to Maximum Headache
time frame: 12 hours
description: Time to maximum headache score on CGRP day compared to placebo day will be assessed using a headache questionnaire
arm group label: Calcitonin Gene-Related Peptide (CGRP)
arm group type: Active Comparator
description: 30 patients with PPTH will be allocated to receive intravenous infusion of 1.5 µg/min calcitonin-gene related peptide over 20 minutes
Other Name: CGRP
arm group label: Placebo
arm group type: Placebo Comparator
description: 30 patients with PPTH wil be allocated to receive 40 mL Placebo (isotonic saline) over 20 minutes.
Other Name: Isotonic Saline
intervention type: Drug
intervention name: Calcitonin Gene-Related Peptide
description: A randomized clinical trial with a double-blinded, randomized, placebo-controlled crossover design. 30 PPTH patients will be included. All participants will receive continuous intravenous infusion of 1.5 µg/min CGRP over 20 min.
The following variables will be recorded before, during and after infusion (every 10 min over 60 min): headache intensity on a verbal rating scale from 0 to 10 and headache characteristics. At 90 min, participants will be discharged and instructed to fill out a headache diary for 24 hours from start of infusion.
arm group label: Calcitonin Gene-Related Peptide (CGRP)
other name: CGRP
intervention type: Drug
intervention name: Placebo
description: A randomized clinical trial with a double-blinded, randomized, placebo-controlled crossover design. 30 PPTH patients will be included. All participants will receive continuous intravenous infusion of 40 mL placebo (isotonic saline) over 20 min.
The following variables will be recorded before, during and after infusion (every 10 min over 60 min): headache intensity on a verbal rating scale from 0 to 10 and headache characteristics. At 90 min, participants will be discharged and instructed to fill out a headache diary for 24 hours from start of infusion.
arm group label: Placebo
other name: Isotonic Saline
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Henrik Schytz, MD
role: Principal Investigator
affiliation: Associate Professor
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Danish Headache Center
investigator full name: Henrik Schytz
investigator title: Associate Professor of Neurology
mesh term: Post-Traumatic Headache
mesh term: Brain Concussion
mesh term: Headache
mesh term: Calcitonin
mesh term: Salmon calcitonin
mesh term: Calcitonin Gene-Related Peptide
mesh term: Katacalcin
sharing ipd: No