Zolmitriptan Nasal Spray Versus Eletriptan in the Acute Treatment of Migraine

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: California Medical Clinic for Headache
• Treatments: Eletriptan; Oxazolidinones; Zolmitriptan

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.