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CGRP-induced Migraine Attacks in Patients Who Have Tried Anti-CGRP Monoclonal Antibody Treatment

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ClinicalTrials.gov Identifier: NCT03481400
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Casper Emil Christensen, Danish Headache Center

Brief Summary:
The investigators aim to investigate the incidence of migraine attacks after calcitonin gene-related peptide (CGRP) infusion in patients who have tried anti-CGRP monoclonal antibody treatment for the prevention of migraine.

Condition or disease Intervention/treatment Phase
Migraine Drug: Calcitonin Gene-Related Peptide Other: Placebo Not Applicable

Detailed Description:

Calcitonin gene-related peptide (CGRP) plays a role in migraine pathophysiology. Infusions of CGRP can trigger migraine-like attacks in migraine patients and antibodies against CGRP or the CGRP receptor significantly reduces the number of migraine days per month when administered regularly. Some patients however, do not experience migraine attack after CGRP infusion, and some do not experience migraine reduction with antibodies. The underlying mechanisms of these effects are largely unknown.

The purpose of this study is to examine CGRP-induced migraine in patients who have evaluated the efficacy of anti-CGRP monoclonal antibody treatment for migraine using a purpose-developed standardized interview. The investigators will use a double-blind, placebo-controlled crossover study design to examine migraine susceptibility to CGRP in these patients.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Placebo-controlled, crossover design.
Masking: Double (Participant, Investigator)
Masking Description: Double-blind study.
Primary Purpose: Other
Official Title: Provoked Migraine Attacks With Calcitonin Gene-related Peptide (CGRP) in Patients Who Have Tried Preventive Treatment With Anti-CGRP Monoclonal Antibodies.
Actual Study Start Date : July 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Calcitonin gene-related peptide
Calcitonin gene-related peptide infusion (1.5 micrograms/min for 20 mins)
Drug: Calcitonin Gene-Related Peptide
Calcitonin gene-related peptide intravenous infusion (1.5 micrograms/min for 20 mins)
Other Name: CGRP
Experimental: Placebo
Infusion with placebo (isotonic saline)
Other: Placebo
Isotonic saline



Primary Outcome Measures :
  1. Incidence of migraine [ Time Frame: From 0 to 12 hours after CGRP infusion ]
    Incidence of migraine after CGRP infusion

  2. Area under the curve of headache intensity [ Time Frame: From 0 to 90 minutes after infusion and from 90 minutes to 12 hours after infusion ]
    Area under the curve of headache intensity from 0-90 min and 90 min-12 hours post infusion


Secondary Outcome Measures :
  1. Heart rate [ Time Frame: From 0 to 90 minutes after infusion ]
    Heart rate (beats per minute)

  2. Blood pressure [ Time Frame: From 0 to 90 minutes after infusion ]
    Blood pressure (millimeter of mercury)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of migraine according to the international classification of headache disorders version 3-beta
  • Subject has tried anti-CGRP antibodies for migraine
  • Women of childbearing potential are on safe contraception

Exclusion Criteria:

  • Women of childbearing potential who do not use contraception. Includes non-hysterectomized women who have not been menopausal for at least two years. Safe contraception includes condoms, intrauterine devices, p-pills, surgical sterilization or gestagen injections.
  • Daily drug intake apart from contraceptives and preventive medication for migraine.
  • Ingestion of any drug 4 half-lifes before study start apart from contraceptives.
  • Pregnant or breast-feeding women
  • Migraine on the study day or less than 48 hours before CGRP infusion.
  • A history of cardiovascular and/or cerebrovascular disease
  • Systolic blood pressure >150 mmHg and/or diastolic blood pressure > 100 mmHg on study day.
  • Systolic blood pressure <90 mmHg and/or diastolic blood pressure < 50 mmHg on study day.
  • A history of mental illness
  • A history of any illness or condition that is deemed relevant for participation by the investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03481400


Contacts
Contact: Casper E Christensen, MD 38632027 casper.emil.christensen.03@regionh.dk
Contact: Samaira Younis, MD 38632176 samaira.younis.01@regionh.dk

Locations
Denmark
Danish Headache Center, Rigshospitalet Glostrup Recruiting
Copenhagen, Glostrup, Denmark, 2600
Contact: Casper E Christensen, MD    38632027    casper.emil.christensen.03@regionh.dk   
Contact: Samaira Younis, MD    38633863    samaira.younis.01@regionh.dk   
Sponsors and Collaborators
Danish Headache Center
Investigators
Study Director: Messoud Ashina, prof. Danish Headache Center

Responsible Party: Casper Emil Christensen, MD, PhD student, Danish Headache Center
ClinicalTrials.gov Identifier: NCT03481400     History of Changes
Other Study ID Numbers: H-16014580
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Casper Emil Christensen, Danish Headache Center:
Calcitonin gene-related peptide

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Antibodies
Antibodies, Monoclonal
Salmon calcitonin
Calcitonin
Calcitonin Gene-Related Peptide
Immunologic Factors
Physiological Effects of Drugs
Bone Density Conservation Agents
Vasodilator Agents