search
Back to results

Calcitonin Gene-related Peptide in Familial Hemiplegic Migraine (FHM) and Migraine With Aura (MA) (CGRP-2008)

Primary Purpose

Familial Hemiplegic Migraine, Migraine With Aura, Healthy

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
CGRP
Sponsored by
Danish Headache Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Familial Hemiplegic Migraine focused on measuring FHM, MA, healthy controls, CGRP

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Danish Headache Center, University of Copenhagen, Faculty of Health Sciences, Department of Neurology, Glostrup Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

1

2

3

Arm Description

MA-patients

FHM-patients

Healthy controls

Outcomes

Primary Outcome Measures

Migraine and associated symptoms

Secondary Outcome Measures

Migraine aura

Full Information

First Posted
May 28, 2008
Last Updated
July 31, 2009
Sponsor
Danish Headache Center
Collaborators
EUROHEAD
search

1. Study Identification

Unique Protocol Identification Number
NCT00687947
Brief Title
Calcitonin Gene-related Peptide in Familial Hemiplegic Migraine (FHM) and Migraine With Aura (MA)
Acronym
CGRP-2008
Official Title
CGRP-induced Headache in Patients With Familial Hemiplegic Migraine, Migraine With Aura and Healthy Controls
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Danish Headache Center
Collaborators
EUROHEAD

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Familial Hemiplegic Migraine, Migraine With Aura, Healthy
Keywords
FHM, MA, healthy controls, CGRP

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
MA-patients
Arm Title
2
Arm Type
Experimental
Arm Description
FHM-patients
Arm Title
3
Arm Type
Active Comparator
Arm Description
Healthy controls
Intervention Type
Drug
Intervention Name(s)
CGRP
Intervention Description
CGRP (0.5 ug/min) infused intravenously over 20 min
Primary Outcome Measure Information:
Title
Migraine and associated symptoms
Time Frame
0-14 h
Secondary Outcome Measure Information:
Title
Migraine aura
Time Frame
0 - 14 h

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jakob Møller Hansen, MD
Organizational Affiliation
Danish Headache Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Danish Headache Center, University of Copenhagen, Faculty of Health Sciences, Department of Neurology, Glostrup Hospital
City
Glostrup, Copenhagen
ZIP/Postal Code
2600
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
18384418
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.
Results Reference
background
PubMed Identifier
18294248
Citation
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.
Results Reference
background
Links:
URL
http://www.glostruphospital.dk/danishheadachecenter/menu
Description
The homepage of the Danish headache center, Glostrup, Copenhagen, Denmark

Learn more about this trial

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

We'll reach out to this number within 24 hrs