Zolmitriptan Nasal Spray Versus Eletriptan in the Acute Treatment of Migraine

Completed · Not applicable

Conditions studied: Acute Migraine, Migraine Headache, Headache Disorders

In brief

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.

Key facts

Study ID

NCT01276977

Run by

California Medical Clinic for Headache

People needed

80

Starts

2008-04-01

Expected to finish

2010-12-01

Last updated by the study team

2011-01-14

Who can join

Age: 15 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• California Medical Clinic for Headache — Santa Monica, California, United States

Full record on ClinicalTrials.gov

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