Zolmitriptan Nasal Spray Versus Eletriptan in the Acute Treatment of Migraine

Overview

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.

Full Title of Study: “Zolmitriptan Nasal Spray VS Eletriptan in the Acute Treatment of Migraine”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2010

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

  • Drug: Zolmitriptan 5 mg Nasal Spray
    • Patients will treat 2 migraine attacks with zolmitriptan 5 mg nasal spray and 2 migraine attacks with eletriptan.
  • Drug: Eletriptan 40 mg tablet
    • Patients will treat 2 migraine attacks with Eletriptan and 2 migraine attacks with zolmitriptan 5 mg nasal spray

Arms, Groups and Cohorts

  • Experimental: Zolmitriptan 5 mg nasal spray
  • Active Comparator: Eletriptan 40 mg Tablet

Clinical Trial Outcome Measures

Primary Measures

  • Reduction of migraine headache pain from mild, moderate or severe to pain free.
    • Time Frame: 30 minutes post-dose

Secondary Measures

  • Reduction of migraine headache pain from mild, moderate or severe to pain free.
    • Time Frame: 15 minutes post-dose

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 15 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • California Medical Clinic for Headache
  • Provider of Information About this Clinical Study
    • David Kudrow, M.D., California Medical Clinic for Headache
  • Overall Official(s)
    • David B Kudrow, MD, Principal Investigator, California Medical Clinic for Headache

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