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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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).

Detailed Summary:

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.


Sponsor: Danish Headache Center

Current Primary Outcome: 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).


Original Primary Outcome: Same as current

Current Secondary Outcome: 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)


Original Secondary Outcome: Same as current

Information By: Danish Headache Center

Dates:
Date Received: August 10, 2013
Date Started: June 2013
Date Completion:
Last Updated: August 14, 2013
Last Verified: August 2013