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

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

Official Title: PACAP 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 PACAP 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 this genetic variant in humans are yet unknown.

PACAP is a neuropeptide which plays a crucial role in the pathophysiology of migraine and is present in migraine relevant structures. PACAP can induce migraine attacks in MO patients via an adenosine monophosphate (cAMP) dependent pathway. Also, a recent study has showed that intracellular accumulation of cAMP is crucial for the induction of migraine attacks.

The phenotype of the migraine inducing effects of PACAP might therefore be linked to some of the 12 genetic susceptibility loci that have been identified.


Sponsor: Danish Headache Center

Current Primary Outcome: Incidence of migraine attacks induced by PACAP 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 PACAP ]

The difference in incidence of migraine-like attacks after PACAP between patients with and without high genetic load and patients with low genetic load using verbal rating scale (VRS).


Original Primary Outcome: PACAP 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 PACAP ]

The difference in incidence of migraine-like attacks between patients with and without high genetic load and patients with low genetic load using verbal rating scale (VRS).


Current Secondary Outcome: Incidence of headache induced by PACAP 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 PACAP ]

The difference in area under the curve (AUC) for headache intensity scores (0-12 hours) after infusion of PACAP


Original Secondary Outcome: PACAP induced migraine attacks in patients with high and low genetic load [ Time Frame: hange from baseline in headache intensity at 12 hours after the start of infusion of PACAP ]

The difference in area under the curve (AUC) for headache intensity scores (0-12 hours)


Information By: Danish Headache Center

Dates:
Date Received: June 5, 2014
Date Started: June 2014
Date Completion:
Last Updated: February 9, 2015
Last Verified: February 2015