Familial Hemiplegic MigraineNCT00541736
Glyceryl-Trinitrate-Induced Headache in Patients With Familial Hemiplegic Migraine
A study testing Nitroglycerine in people with Familial Hemiplegic Migraine, run by Danish Headache Center at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Familial Hemiplegic Migraine
- What is being tested?
- Nitroglycerine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2007to May 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of familial hemiplegic migraine (IHS-classification criteria)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Danish Headache Center, University of Copenhagen, Faculty of Health Sciences, Department of Neurology, Glostrup Hospital
Glostrup, Copenhagen, 2600
About this study
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.
Read the 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.
- Conditions
- Familial Hemiplegic Migraine
- Being tested
- Nitroglycerine
- Keywords
- Familial Hemiplegic Migraine
- Medical subject headings
- Migraine with Aura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitroglycerineDrug
Nitroglycerine infusion over 20 minutes: 0.5 ug/kg/min
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | GTN-infusion Receives: Drug: Nitroglycerine |
| Controls | Active comparator | GTN-infusion Receives: Drug: Nitroglycerine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migraine and associated symptoms
Measured: 0-14 h
Migraine aura
Measured: 0 - 14 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial Hemiplegic MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Collaborators
- EUROHEAD
- Investigators
- Jakob Møller Hansen, MD, Principal investigator, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00541736
- Sponsor's protocol ID
- FHM-GTN-2007-08
- Status last verified
- May 2008
- First submitted
- 9 Oct 2007
- Last updated
- 29 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glyceryl-Trinitrate-Induced Headache in Patients With Familial Hemiplegic Migraine
- ClinicalTrials.gov ID
- NCT00541736
- Acronym / sponsor ID
- FHM-GTN-2007-08
- Conditions
- Familial Hemiplegic Migraine
- Keywords
- Familial Hemiplegic Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Collaborators
- EUROHEAD
- Study start
- Oct 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 10 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Drug: NitroglycerineGTN-infusion |
| Controls | Active comparator | Drug: NitroglycerineGTN-infusion |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of familial hemiplegic migraine (IHS-classification criteria)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NitroglycerineNitroglycerine infusion over 20 minutes: 0.5 ug/kg/min | Drug | Controls, Patients |
Primary outcome
Migraine and associated symptoms
Time frame: 0-14 h
Migraine aura
Time frame: 0 - 14 h
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2008.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jakob Møller Hansen, MD principal investigator
Danish Headache Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nitroglycerine in people with Familial Hemiplegic Migraine, run by Danish Headache Center at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Migraine and associated symptoms (time frame: 0-14 h). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2008.