Zolmitriptan Nasal Spray Versus Eletriptan in the Acute Treatment of Migraine

Not Applicable

Completed

• Conditions: Migraine Headache; Acute Migraine; Headache Disorders
• Interventions: Drug: Zolmitriptan 5 mg Nasal Spray; Drug: Eletriptan 40 mg tablet

• Registration Number: NCT01276977
• Lead Sponsor: California Medical Clinic for 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.

Study Timeline

• Study Start: 2008-04
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-01
• Study First Submitted: 2011-01-11
• Study First Submitted QC: 2011-01-13
• Last Update Submitted: 2011-01-13
• Study First Posted: 2011-01-14
• Last Update Posted: 2011-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Zolmitriptan 5 mg nasal spray	Eletriptan 40 mg tablet	-
Eletriptan 40 mg Tablet	Eletriptan 40 mg tablet	-
Zolmitriptan 5 mg nasal spray	Zolmitriptan 5 mg Nasal Spray	-
Eletriptan 40 mg Tablet	Zolmitriptan 5 mg Nasal Spray	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

California Medical Clinic for Headache; 🇺🇸 Santa Monica, California, United States