NCT00257985

Brief Summary

The aim of the present study is to explore functional consequences of migraine gene mutations on their responses to GTN infusion.

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 Apr 2005

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

April 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 24, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

August 1, 2006

Status Verified

November 1, 2005

First QC Date

November 22, 2005

Last Update Submit

July 31, 2006

Conditions

Familial Hemiplegic Migraine Type 1 and 2Healthy Volunteers

Keywords

Familial hemiplegic migraine type 1 and 2GTNmiddle cerebral arterysuperficial temporal arteryheadachegenotype

Outcome Measures

Primary Outcomes (1)

  • headache and associated symptoms , blood flow velocity of the middle cerebral artery, diameter of the superficial temporal artery

Secondary Outcomes (1)

  • MAP, HR

Interventions

GTNDRUG

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Controls: No primary headache in their own history
  • 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, Department of Neurology, Glostrup Hospital

Glostrup, Copenhagen, DK-2600, Denmark

Location

MeSH Terms

Conditions

Hemiplegic migraine, familial type 1Headache

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jakob Møller Hansen, MD

    Danish Headache Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Purpose
ECT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 22, 2005

First Posted

November 24, 2005

Study Start

April 1, 2005

Study Completion

March 1, 2006

Last Updated

August 1, 2006

Record last verified: 2005-11

Locations

DK(1)