Acute Migraine, Headache Disorders, Migraine Headache
Conditions
Keywords
Migraine, Acute Migraine, Headache
Brief summary
The purpose of this study is to Compare the efficacy of zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg tablet in the acute treatment of migraine. To develop and evaluate a set of importance weights for a predefined set of treatment attributes for migraine suffers using zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg tablet. To contrast the efficacy of zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg tablet at early time points. To analyze the patterns of self-reported tolerability of migraine sufferers using zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg tablet.
Detailed description
An open-label, randomized, cross-over study comparing the efficacy of zolmitriptan 5 mg nasal spray with eletriptan 40 mg tablet at early time points. Satisfaction endpoints include global assessment of preference, overall satisfaction and effectiveness as well as tolerability of both medications.
Interventions
DRUGZolmitriptan 5 mg Nasal Spray
Patients will treat 2 migraine attacks with zolmitriptan 5 mg nasal spray and 2 migraine attacks with eletriptan.
DRUGEletriptan 40 mg tablet
Patients will treat 2 migraine attacks with Eletriptan and 2 migraine attacks with zolmitriptan 5 mg nasal spray
Sponsors
California Medical Clinic for Headache
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 15 to 70 years old * Migraine attacks according to the criteria proposed by the IHS * 3-12 Migraine attacks per month * adequate contraception * Willing and able to give written informed consent * Willing and able to complete the entire course of the study & comply with instructions * Stable dose of preventive medication for at least 4 weeks
Exclusion criteria
* Disorders listen in groups 5-11 of the IHS Classification * Subject is pregnant or lactating. * Significant medical or psychiatric disease * Subject has a history of symptoms suggestive of ischemic heart disease (angina, myocardial infarction, documented silent ischemia) or other vascular disease, including Prinzmetal angina, claudication, Wolff-Parkinson-White syndrome, or other cardiac accessory conduction pathway arrhythmia * Subject has uncontrolled hypertension. * Subject has history of basilar, ophthalmoplegic, or hemiplegic migraine or serious neurologic condition associated with headache * Subject has used monoamine oxidase A inhibitors (MAOI-As) within 2 weeks of randomization * Subject has had serious adverse event while using another 5-HT agonist, or previous serious adverse event while using zolmitriptan or hypersensitivity to zolmitriptan or eletriptan * Using CYP3A4 inhibitors listed by the FDA as contraindicated with eletriptan * Moderate/severe hepatic/renal impairment * Subject currently using cimetidine * Concomitant medication treatment with a triptan, ergotamine or methysergide.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of migraine headache pain from mild, moderate or severe to pain free. | 30 minutes post-dose |
Secondary
| Measure | Time frame |
|---|---|
| Reduction of migraine headache pain from mild, moderate or severe to pain free. | 15 minutes post-dose |
Countries
United States
Outcome results
None listed