Glyceryl-Trinitrate-Induced Headache in Patients With Familial Hemiplegic Migraine
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Familial Hemiplegic Migraine |
Drug: Nitroglycerine |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Glyceryl-Trinitrate-Induced Headache in Patients With Familial Hemiplegic Migraine |
- Migraine and associated symptoms [ Time Frame: 0-14 h ]
- Migraine aura [ Time Frame: 0 - 14 h ]
| Enrollment: | 30 |
| Study Start Date: | October 2007 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Patients
GTN-infusion
|
Drug: Nitroglycerine
Nitroglycerine infusion over 20 minutes: 0.5 ug/kg/min
|
|
Active Comparator: Controls
GTN-infusion
|
Drug: Nitroglycerine
Nitroglycerine infusion over 20 minutes: 0.5 ug/kg/min
|
Detailed Description:
Glyceryl trinitrate (GTN) induces migraine attacks indistinguishable from spontaneous attacks in approximately 80% of migraine sufferers. After systemic administration GTN is transformed to nitric oxide (NO). Treatment of spontaneous migraine attacks with an inhibitor of NO is effective in 60% of patients. These data show that NO is involved in both initiation and maintenance of migraine attack.
The importance of migraine genes 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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Diagnosis of familial hemiplegic migraine (IHS-classification criteria)
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
Contacts and Locations| Denmark | |
| Danish Headache Center, University of Copenhagen, Faculty of Health Sciences, Department of Neurology, Glostrup Hospital | |
| Glostrup, Copenhagen, Denmark, 2600 | |
| Principal Investigator: | Jakob Møller Hansen, MD | Danish Headache Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00541736 History of Changes |
| Other Study ID Numbers: | FHM-GTN-2007-08 |
| Study First Received: | October 9, 2007 |
| Last Updated: | May 28, 2008 |
| Health Authority: | Denmark: Ethics Committee |
Keywords provided by Danish Headache Center:
|
Familial Hemiplegic Migraine |
Additional relevant MeSH terms:
|
Headache Migraine Disorders Migraine with Aura Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Headache Disorders, Primary |
Headache Disorders Brain Diseases Central Nervous System Diseases Nitroglycerin Vasodilator Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013