Zolmitriptan Nasal Spray Versus Eletriptan in the Acute Treatment of Migraine

NCT ID: NCT01276977

Last Updated: 2011-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2010-12-31

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.

Conditions

Acute Migraine; Migraine Headache; Headache Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Zolmitriptan 5 mg nasal spray

Group Type: EXPERIMENTAL

Zolmitriptan 5 mg Nasal Spray

Intervention Type: DRUG

Patients will treat 2 migraine attacks with zolmitriptan 5 mg nasal spray and 2 migraine attacks with eletriptan.

Eletriptan 40 mg tablet

Intervention Type: DRUG

Patients will treat 2 migraine attacks with Eletriptan and 2 migraine attacks with zolmitriptan 5 mg nasal spray

Eletriptan 40 mg Tablet

Group Type: ACTIVE_COMPARATOR

Zolmitriptan 5 mg Nasal Spray

Intervention Type: DRUG

Patients will treat 2 migraine attacks with zolmitriptan 5 mg nasal spray and 2 migraine attacks with eletriptan.

Eletriptan 40 mg tablet

Intervention Type: DRUG

Patients will treat 2 migraine attacks with Eletriptan and 2 migraine attacks with zolmitriptan 5 mg nasal spray

Interventions

Zolmitriptan 5 mg Nasal Spray

Patients will treat 2 migraine attacks with zolmitriptan 5 mg nasal spray and 2 migraine attacks with eletriptan.

Intervention Type: DRUG

Eletriptan 40 mg tablet

Patients will treat 2 migraine attacks with Eletriptan and 2 migraine attacks with zolmitriptan 5 mg nasal spray

Intervention Type: DRUG

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

California Medical Clinic for Headache

OTHER

Sponsor Role: lead

Responsible Party

California Medical Clinic for Headache

Principal Investigators

David B Kudrow, MD

Role: PRINCIPAL_INVESTIGATOR

California Medical Clinic for Headache

Locations

California Medical Clinic for Headache

Santa Monica, California, United States

Countries

United States

Other Identifiers

IRUSZOLM0028

Identifier Type: -

Identifier Source: org_study_id