Calcitonin Gene-related Peptide in Familial Hemiplegic Migraine (FHM) and Migraine With Aura (MA)

Healthy Clinical Trial

— CGRP-2008  

Official title:

CGRP-induced Headache in Patients With Familial Hemiplegic Migraine, Migraine With Aura and Healthy Controls

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00687947
• Other study ID #: FHM-CGRP-MA-2008
• Status: Completed
• Phase: N/A
• First received: May 28, 2008
• Last updated: July 31, 2009
• Start date: May 2008
• Est. completion date: August 2008

Study information

• Verified date: July 2009
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The aim of the present study is to explore the importance of migraine phenotype on the headache/migraine responses after CGRP in FHM-patients, MA-patients and healthy volunteers.

Description:

Calcitonin gene-related peptide (CGRP) induces migraine attacks indistinguishable from spontaneous attacks in a large proportion of migraine sufferers. Treatment of spontaneous migraine attacks with an inhibitor of CGRP is effective in many patients. These data show that CGRP is involved in migraine pathophysiology.

The importance of migraine genetics is disputed. Evidence from FHM patients with known mutations indicates that migraine pathways in FHM may be different from normal migraine. The aim of the present study is to examine whether this difference also exists in FHM patients without known mutations. The project will improve our understanding of the neurobiology of migraine and stimulate development of new treatment targets.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Diagnosis of familial hemiplegic migraine (IHS-classification criteria)

• Diagnosis of migraine with aura(IHS-classification criteria)

• Healthy controls

Exclusion Criteria:

Patients and controls:

• A history of cerebrovascular disease and other CNS- disease

• A history of serious somatic and mental disease

• A history suggesting ischaemic heart disease

• A history of hypo- or hypertension

• Daily intake of medication apart from oral contraceptives

• Abuse of alcohol or medicine (opioid analgesics).

• Pregnant or breastfeeding women.

• On the study day:

• No intake of a simple analgesic in the previous 48 hours

• No headache in the previous 48 hours

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Familial Hemiplegic Migraine
• Healthy
• Migraine Disorders
• Migraine with Aura

Intervention

Drug:
• CGRP
CGRP (0.5 ug/min) infused intravenously over 20 min

Locations

Country	Name	City	State
Denmark	Danish Headache Center, University of Copenhagen, Faculty of Health Sciences, Department of Neurology, Glostrup Hospital	Glostrup, Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Danish Headache Center	EUROHEAD

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

Hansen JM, Thomsen LL, Marconi R, Casari G, Olesen J, Ashina M. Familial hemiplegic migraine type 2 does not share hypersensitivity to nitric oxide with common types of migraine. Cephalalgia. 2008 Apr;28(4):367-75. doi: 10.1111/j.1468-2982.2008.01542.x. Epub 2008 Feb 22. — View Citation

Hansen JM, Thomsen LL, Olesen J, Ashina M. Familial hemiplegic migraine type 1 shows no hypersensitivity to nitric oxide. Cephalalgia. 2008 May;28(5):496-505. doi: 10.1111/j.1468-2982.2008.01559.x. Epub 2008 Mar 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Migraine and associated symptoms		0-14 h	No
Secondary	Migraine aura		0 - 14 h	No