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

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.

Study Overview

• Status: Completed
• Conditions: Familial Hemiplegic Migraine
• Intervention / Treatment: Drug: CGRP

Detailed 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.

• Study Type: Interventional
• Enrollment: 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Glostrup, Copenhagen, Denmark, 2600
    • Danish Headache Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Educational/Counseling/Training
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
headache and associated symptoms
blood flow velocity of the middle cerebral artery
diameter of the superficial temporal artery

Secondary Outcome Measures

Outcome Measure
MAP
HR

Collaborators and Investigators

• Sponsor: Danish Headache Center
• Collaborators: EUROHEAD

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion: December 7, 2022
• Study Completion: October 1, 2006

Study Registration Dates

• First Submitted: July 31, 2006
• First Submitted That Met QC Criteria: July 31, 2006
• First Posted (Estimate): August 1, 2006

Study Record Updates

• Last Update Posted (Estimate): November 10, 2006
• Last Update Submitted That Met QC Criteria: November 9, 2006
• Last Verified: November 1, 2006

More Information

Terms related to this study

• Keywords: Healthy Volunteers; middle cerebral artery; headache; CGRP; Familial hemiplegic migraine type 1 and 2; superficial temporal artery; genotype
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache; Migraine with Aura
• Other Study ID Numbers: FHM-CGRP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No