NCT00687947

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 2, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

August 3, 2009

Status Verified

July 1, 2009

Enrollment Period

3 months

First QC Date

May 28, 2008

Last Update Submit

July 31, 2009

Conditions

Keywords

FHMMAhealthy controlsCGRP

Outcome Measures

Primary Outcomes (1)

  • Migraine and associated symptoms

    0-14 h

Secondary Outcomes (1)

  • Migraine aura

    0 - 14 h

Study Arms (3)

1

EXPERIMENTAL

MA-patients

Drug: CGRP

2

EXPERIMENTAL

FHM-patients

Drug: CGRP

3

ACTIVE COMPARATOR

Healthy controls

Drug: CGRP

Interventions

CGRPDRUG

CGRP (0.5 ug/min) infused intravenously over 20 min

123

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of familial hemiplegic migraine (IHS-classification criteria)
  • Diagnosis of migraine with aura(IHS-classification criteria)
  • Healthy controls

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Glostrup, Copenhagen, 2600, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 18384418BACKGROUND
  • 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.

    PMID: 18294248BACKGROUND

Related Links

MeSH Terms

Conditions

Migraine with Aura

Condition Hierarchy (Ancestors)

Migraine DisordersHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Jakob Møller Hansen, MD

    Danish Headache Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 28, 2008

First Posted

June 2, 2008

Study Start

May 1, 2008

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

August 3, 2009

Record last verified: 2009-07

Locations