Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-24 @ 10:23 PM
NCT ID:
NCT00126035
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00126035
Study Brief:
Protocol Section:
NCT00126035