NCT00358839

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2006

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 31, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

November 10, 2006

Status Verified

November 1, 2006

First QC Date

July 31, 2006

Last Update Submit

November 9, 2006

Conditions

Familial Hemiplegic Migraine

Keywords

Familial hemiplegic migraine type 1 and 2CGRPmiddle cerebral arterysuperficial temporal arteryheadachegenotypeHealthy Volunteers

Outcome Measures

Primary Outcomes (3)

  • headache and associated symptoms

  • blood flow velocity of the middle cerebral artery

  • diameter of the superficial temporal artery

Secondary Outcomes (2)

  • MAP

  • HR

Interventions

CGRPDRUG

Eligibility Criteria

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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danish Headache Center

Glostrup, Copenhagen, 2600, Denmark

Location

MeSH Terms

Conditions

Migraine with AuraHemiplegic migraine, familial type 1Headache

Condition Hierarchy (Ancestors)

Migraine DisordersHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic 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
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 31, 2006

First Posted

August 1, 2006

Study Start

July 1, 2006

Study Completion

October 1, 2006

Last Updated

November 10, 2006

Record last verified: 2006-11

Locations

DK(1)