CGRP Induced Migraine Attacks in Patients With High and Low Genetic Load

July 31, 2022 updated by: Song Guo, Danish Headache Center
The investigators hypothesized that migraine without patients with many genetic loci associated with migraine (high genetic load) would be more sensitive and get provoked more migraine attacks by calcitonin gene-related peptide (CGRP) compared to patients with few genetic loci associated with migraine (low genetic load).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Migraine is a very prevalent neurological disorder with a strong genetic factor. The common forms of migraine have a multifactorial and polygenic pattern of inheritance and genetics research is crucial for a deeper understanding of migraine mechanisms. Recently, 12 genetic loci have been identified to be associated with migraine with (MA) and without aura (MA) in four large genome-wide association studies (GWAS). The functional consequences of these genetic loci in humans are yet unknown.

Calcitonin gene-related peptide (CGRP) is a neuropeptide which plays a crucial role in the pathophysiology of migraine and is present in migraine relevant structures. CGRP can induce migraine attacks in MO patients via an adenosine monophosphate (cAMP) dependent pathway and CGRP antagonism is efficient in the treatment of migraine attacks. Also, a recent study has showed that intracellular accumulation of cAMP is crucial for the induction of migraine attacks. However, CGRP does not cause migraine attacks in familial hemiplegic migraine (FHM), an autosomal dominant subtype of MA.

The phenotype of the migraine inducing effects of CGRP might therefore be linked to some of the 12 genetic susceptibility loci that have been identified. One of the genetic loci (rs13208321) is located in a gene (FHL5) that is associated with the regulation of cAMP-responsive elements.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

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:

- Migraine without aura patients genotyped for the 12 newly idetified gene variants associated with migraine.

Exclusion Criteria:

  • Other primary headache
  • A history of cerebrovascular disease and other CNS- disease
  • A history suggesting ischaemic heart disease
  • Serious somatic and mental disease
  • Hypo- or hypertension
  • Abuse of alcohol or medicine (opioid analgesics).
  • Pregnant or breastfeeding women.

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Migraine patients with high genetic load
CGRP intravenous infusion 1.5 microgram/min for 20 min
Drug: CGRP
Calcitonin-gene-related-peptide (CGRP)
Other Names:
  • calcitonin-gene-related peptide
Active Comparator: Migraine patients with low genetic load
CGRP intravenous infusion 1.5 microgram/min for 20 min
Drug: CGRP
Calcitonin-gene-related-peptide (CGRP)
Other Names:
  • calcitonin-gene-related peptide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CGRP induced migraine attacks in patients with high and low genetic load
Time Frame: Change from baseline in headache intensity at 12 hours after the start of infusion of CGRP
The difference in incidence of migraine-like attacks between patients with high genetic load and patients with low genetic load using verbal rating scale (VRS).
Change from baseline in headache intensity at 12 hours after the start of infusion of CGRP

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CGRP induced migraine attacks in patients with high and low genetic load
Time Frame: Change from baseline in headache intensity at 12 hours after the start of infusion of CGRP
The difference in area under the curve (AUC) for headache intensity scores (0-12 hours)
Change from baseline in headache intensity at 12 hours after the start of infusion of CGRP

Collaborators and Investigators

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

Sponsor

Danish Headache Center

Investigators

  • Principal Investigator: Song Guo, MD, Danish Headache Center & Department of Neurology

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

June 1, 2013

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

August 10, 2013

First Submitted That Met QC Criteria

August 14, 2013

First Posted (Estimate)

August 16, 2013

Study Record Updates

Last Update Posted (Actual)

August 2, 2022

Last Update Submitted That Met QC Criteria

July 31, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2-2011-141

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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