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Zolmitriptan Nasal Spray Versus Eletriptan in the Acute Treatment of Migraine

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01276977

First Posted: January 14, 2011

Last Update Posted: January 14, 2011

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

California Medical Clinic for Headache

Purpose

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.

Condition	Intervention
Acute Migraine Migraine Headache Headache Disorders	Drug: Zolmitriptan 5 mg Nasal Spray Drug: Eletriptan 40 mg tablet


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Zolmitriptan Nasal Spray VS Eletriptan in the Acute Treatment of Migraine

Resource links provided by NLM:

MedlinePlus related topics: Headache Migraine

Drug Information available for: Zolmitriptan Eletriptan Eletriptan Hydrobromide

U.S. FDA Resources

Further study details as provided by California Medical Clinic for Headache:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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


Enrollment:	80
Study Start Date:	April 2008
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Zolmitriptan 5 mg nasal spray	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
Active Comparator: Eletriptan 40 mg Tablet	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

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.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	15 Years to 70 Years (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01276977

Locations


United States, California
California Medical Clinic for Headache
Santa Monica, California, United States, 90404

Sponsors and Collaborators

California Medical Clinic for Headache

Investigators


Principal Investigator:	David B Kudrow, MD	California Medical Clinic for Headache

More Information


Responsible Party:	David Kudrow, M.D., California Medical Clinic for Headache
ClinicalTrials.gov Identifier:	NCT01276977 History of Changes
Other Study ID Numbers:	IRUSZOLM0028
First Submitted:	January 11, 2011
First Posted:	January 14, 2011
Last Update Posted:	January 14, 2011
Last Verified:	January 2011

Keywords provided by California Medical Clinic for Headache:


Migraine Acute Migraine Headache

Additional relevant MeSH terms:


Migraine Disorders Headache Headache Disorders Headache Disorders, Primary Brain Diseases Central Nervous System Diseases Nervous System Diseases Pain Neurologic Manifestations Signs and Symptoms Eletriptan	Zolmitriptan Oxazolidinones Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Serotonin 5-HT1 Receptor Agonists Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors

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