Zolmitriptan Nasal Spray Versus Eletriptan in the Acute Treatment of Migraine

This study has been completed.

Sponsor:

Information provided by:

California Medical Clinic for Headache

ClinicalTrials.gov Identifier:

NCT01276977

First received: January 11, 2011

Last updated: January 13, 2011

Last verified: January 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

January 11, 2011

Last Updated Date

January 13, 2011

Start Date ^ICMJE

April 2008

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Reduction of migraine headache pain from mild, moderate or severe to pain free. [ Time Frame: 30 minutes post-dose ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01276977 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Reduction of migraine headache pain from mild, moderate or severe to pain free. [ Time Frame: 15 minutes post-dose ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Zolmitriptan Nasal Spray Versus Eletriptan in the Acute Treatment of Migraine

Official Title ^ICMJE

Zolmitriptan Nasal Spray VS Eletriptan in the Acute Treatment of Migraine

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Acute Migraine
Migraine Headache
Headache Disorders

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Zolmitriptan 5 mg nasal spray
Interventions:
- Drug: Zolmitriptan 5 mg Nasal Spray
- Drug: Eletriptan 40 mg tablet
Active Comparator: Eletriptan 40 mg Tablet
Interventions:
- Drug: Zolmitriptan 5 mg Nasal Spray
- Drug: Eletriptan 40 mg tablet

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2010

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

15 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01276977

Other Study ID Numbers ^ICMJE

IRUSZOLM0028

Has Data Monitoring Committee

Responsible Party

David Kudrow, M.D., California Medical Clinic for Headache

Study Sponsor ^ICMJE

California Medical Clinic for Headache

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

David B Kudrow, MD

California Medical Clinic for Headache

Information Provided By

California Medical Clinic for Headache

Verification Date

January 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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