Zolmitriptan Nasal Spray Versus Eletriptan in the Acute Treatment of Migraine - Full Text View

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 Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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


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


Ages Eligible for Study:	15 Years to 70 Years
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided


Responsible Party:	David Kudrow, M.D., California Medical Clinic for Headache
ClinicalTrials.gov Identifier:	NCT01276977 History of Changes
Other Study ID Numbers:	IRUSZOLM0028
Study First Received:	January 11, 2011
Last Updated:	January 13, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by California Medical Clinic for Headache:


Migraine Acute Migraine Headache

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on February 25, 2015