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

Migraine Without Aura Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02158221
• Other study ID #: H-2-2013-043
• Status: Completed
• Phase: N/A
• First received: June 5, 2014
• Last updated: February 9, 2015
• Start date: June 2014
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Migraine Disorders
• Migraine without Aura

Intervention

Drug:
• PACAP
Pituitary adenylate cyclase-activating polypeptide (PACAP)

Locations

Country	Name	City	State
Denmark	Danish Headache Center & Department of Neurology	Copenhagen	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of migraine attacks induced by PACAP in patients with high and low genetic load.	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).	Change from baseline in headache intensity at 12 hours after the start of infusion of PACAP	No
Secondary	Incidence of headache induced by PACAP in patients with high and low genetic load.	The difference in area under the curve (AUC) for headache intensity scores (0-12 hours) after infusion of PACAP	Change from baseline in headache intensity at 12 hours after the start of infusion of PACAP	No