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

March 27, 2018 updated by: Casper Emil Christensen, Danish Headache Center

Provoked Migraine Attacks With Calcitonin Gene-related Peptide (CGRP) in Patients Who Have Tried Preventive Treatment With Anti-CGRP Monoclonal Antibodies.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • CGRP
Experimental: Placebo
Infusion with placebo (isotonic saline)
Other: Placebo
Isotonic saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of migraine
Time Frame: From 0 to 12 hours after CGRP infusion
Incidence of migraine after CGRP infusion
From 0 to 12 hours after CGRP infusion
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
From 0 to 90 minutes after infusion and from 90 minutes to 12 hours after infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate
Time Frame: From 0 to 90 minutes after infusion
Heart rate (beats per minute)
From 0 to 90 minutes after infusion
Blood pressure
Time Frame: From 0 to 90 minutes after infusion
Blood pressure (millimeter of mercury)
From 0 to 90 minutes after infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish Headache Center

Investigators

  • Study Director: Messoud Ashina, prof., Danish Headache Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

March 13, 2018

First Submitted That Met QC Criteria

March 27, 2018

First Posted (Actual)

March 29, 2018

Study Record Updates

Last Update Posted (Actual)

March 29, 2018

Last Update Submitted That Met QC Criteria

March 27, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-16014580

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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