Calcitonin Gene Related Peptide-Induced Headache in Patients With Familial Hemiplegic Migraine Type 1 and 2.

Familial Hemiplegic Migraine Clinical Trial

Official title:

Calcitonin Gene Related Peptide-Induced Headache in Patients With Familial Hemiplegic Migraine Type 1 and 2.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00358839
• Other study ID #: FHM-CGRP
• Status: Completed
• Phase: N/A
• First received: July 31, 2006
• Last updated: November 9, 2006
• Start date: July 2006
• Est. completion date: October 2006

Study information

• Verified date: November 2006
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Den Centrale Videnskabsetiske Komité
• Study type: Interventional

Clinical Trial Summary

The aim of the present study is to explore functional consequences of migraine gene mutations on their responses to Calcitonin Gene Related Peptide (CGRP)infusion.

Description:

Calcitonin Gene Related Peptide (CGRP) induces migraine attacks indistinguishable from spontaneous attacks in approximately 50% of migraine sufferers. Treatment of spontaneous migraine attacks with an antagonist to CGRP is effective in many patients. These data show that CGRP is involved in both initiation and maintenance of migraine attack.

The consequence of migraine gene mutations on relevant migraine pathways has never been tested. The aim of the present study is to explore functional consequences of migraine gene mutations on their responses to CGRP infusion. The project will improve our understanding of the neurobiology of migraine and stimulate development of new treatment targets.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Patients: Diagnosis of familial hemiplegic migraine (IHS-classification criteria) caused by mutations in the CACNA1A gene and the ATP1A2 gene.

Controls: Healthy volunteers

Exclusion Criteria:

Controls: No primary headache in their own history 2) 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: Single Blind, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Familial Hemiplegic Migraine
• Headache
• Migraine Disorders
• Migraine with Aura

Intervention

Drug:
• CGRP

Locations

Country	Name	City	State
Denmark	Danish Headache Center	Glostrup, Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Danish Headache Center	EUROHEAD

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	headache and associated symptoms
Primary	blood flow velocity of the middle cerebral artery
Primary	diameter of the superficial temporal artery
Secondary	MAP
Secondary	HR