Status:
COMPLETED
Study With Migraid Device in Acute, Early Treatment of Migraine With Typical Aura
Lead Sponsor:
Profess Medical Consultancy
Conditions:
Migraine With Typical Aura
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The purpose of the study was to assess the efficacy of Migraid in terms of preventing headaches in patients with migraine with typical aura. The secondary objectives were to assess whether Migraid is ...
Detailed Description
Migraid is to be used only once during the aura phase of a migraine attack for a duration of 60 minutes. Reference therapy: No treatment. This means that at random the patient will be allocated to ei...
Eligibility Criteria
Inclusion
- Patients must have a current history of migraine with typical aura where the aura is usually followed by headache according to the International Headache Society (IHS) criteria.
- Patients are male or female. N.B. When female patients are treated for migraine attacks with triptans then the required precautions and safety measures should be taken in order to prevent pregnancy.
- Patients with an age between 18 and 65 years.
- Patients must have experienced 1-4 moderate (grade 2) or severe (grade 3) migraine attacks per month for at least two months prior to entry into the study.
- Patients must be willing to keep their prophylactic drug treatment for migraine unchanged.
- Patients must be able to distinguish migraine headaches from other headache types (e.g. tension-type headaches) at the onset of a migraine attack.
- Patients must be able to understand and complete the diary card
- Patients must be willing and able to give written informed consent prior to entry into the study.
- Patients must be willing and able to carry the Migraid and, if necessary, apply it in a public place.
Exclusion
- Migraine patients with a typical aura but without any migraine headache thereafter.
- Patients with a history suggestive of ischaemic heart disease (IHD) or any present evidence of ischaemic heart disease (like angina pectoris, previous myocardial infarction, documented silent ischaemia, Prinzmetal's angina), or symptoms consistent with IHD.
- Patients suffering from coronary vasospasm or any atherosclerotic disease (cerebrovascular disease \[CVD\], peripheral vascular disease \[PVD\] or Raynaud's disease) which places them at increased risk of coronary ischaemia.
- Patients with a history of cerebrovascular accident (CVA) or transient ischaemic attacks (TIA).
- Patients with a supine diastolic blood pressure of \> 95 mm Hg and/or systolic blood pressure \> 160 mm Hg (treated or untreated) at Visit 1.
- Patients with a history of epilepsy or structural brain lesions which lower their convulsion threshold.
- Patients with tension-type headaches \> 15 days/month in either of the two months prior to the study.
- Current abuse of opioid analgesics or other psychotropic drugs. History (within the past year) or current abuse of ergotamine (abuse as defined as \> 10 mg/week). Current abuse of alcohol (according to local recommendations) or other drugs.
- Patients suffering from any severe concurrent medical condition which may affect the interpretation of efficacy and safety data or which otherwise contraindicates participation in a clinical study.
- Patients with a history of ophthalmoplegic, basilar or hemiplegic migraine.
- Patients with a history of impaired hepatic or renal function.
- Patients who have participated in a clinical trial within the previous 3 months or are planning to participate in another clinical research study at any time during this study.
- Patients with any concurrent medical or psychiatric condition that, in the investigator's opinion, may affect the interpretation of efficacy or safety data or which otherwise contraindicates participation in a clinical trial.
- Patients cannot be participating investigators, study co-ordinators, employees of investigators, or family members of any of the aforementioned.
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2004
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT00126035
Start Date
February 1 2004
End Date
December 1 2004
Last Update
August 17 2005
Active Locations (1)
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1
Multicentre study with 21 General practitioners
Haarlem, North Holland, Netherlands