NCT00541736

Brief Summary

The aim of the present study is to explore the importance of migraine genes on the headache/migraine responses after GTN in FHM-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 Oct 2007

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

October 1, 2007

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 10, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

May 29, 2008

Status Verified

May 1, 2008

Enrollment Period

7 months

First QC Date

October 9, 2007

Last Update Submit

May 28, 2008

Conditions

Familial Hemiplegic Migraine

Keywords

Familial Hemiplegic Migraine

Outcome Measures

Primary Outcomes (2)

  • Migraine and associated symptoms

    0-14 h

  • Migraine aura

    0 - 14 h

Study Arms (2)

Patients

EXPERIMENTAL

GTN-infusion

Drug: Nitroglycerine

Controls

ACTIVE COMPARATOR

GTN-infusion

Drug: Nitroglycerine

Interventions

NitroglycerineDRUG

Nitroglycerine infusion over 20 minutes: 0.5 ug/kg/min

ControlsPatients

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)

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

MeSH Terms

Conditions

Migraine with Aura

Interventions

Nitroglycerin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nitro CompoundsOrganic Chemicals

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

October 9, 2007

First Posted

October 10, 2007

Study Start

October 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

May 29, 2008

Record last verified: 2008-05

Locations

DK(1)