Zolmitriptan Nasal Spray Versus Eletriptan in the Acute Treatment of Migraine

Study Overview
=================
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.

Official Title
-----------------
Zolmitriptan Nasal Spray VS Eletriptan in the Acute Treatment of Migraine

Conditions
-----------------
Acute Migraine, Migraine Headache, Headache Disorders

Intervention / Treatment
-----------------
* Drug: Zolmitriptan 5 mg Nasal Spray
* Drug: Eletriptan 40 mg tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zolmitriptan 5 mg nasal spray<br> | Drug: Zolmitriptan 5 mg Nasal Spray<br>* Patients will treat 2 migraine attacks with zolmitriptan 5 mg nasal spray and 2 migraine attacks with eletriptan.<br>Drug: Eletriptan 40 mg tablet<br>* Patients will treat 2 migraine attacks with Eletriptan and 2 migraine attacks with zolmitriptan 5 mg nasal spray<br>|
| Active Comparator: Eletriptan 40 mg Tablet<br> | Drug: Zolmitriptan 5 mg Nasal Spray<br>* Patients will treat 2 migraine attacks with zolmitriptan 5 mg nasal spray and 2 migraine attacks with eletriptan.<br>Drug: Eletriptan 40 mg tablet<br>* Patients will treat 2 migraine attacks with Eletriptan and 2 migraine attacks with zolmitriptan 5 mg nasal spray<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of migraine headache pain from mild, moderate or severe to pain free. |  | 30 minutes post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of migraine headache pain from mild, moderate or severe to pain free. |  | 15 minutes post-dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Migraine, Acute Migraine, Headache