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Zolmitriptan Nasal Spray Versus Eletriptan in the Acute Treatment of Migraine

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ClinicalTrials.gov Identifier: NCT01276977
Recruitment Status : Completed
First Posted : January 14, 2011
Last Update Posted : January 14, 2011
Sponsor:
Information provided by:
California Medical Clinic for Headache

Study Description
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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.


Condition or disease Intervention/treatment Phase
Acute Migraine Migraine Headache Headache Disorders Drug: Zolmitriptan 5 mg Nasal Spray Drug: Eletriptan 40 mg tablet Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
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
Study Start Date : April 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arms and Interventions
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Arm Intervention/treatment
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


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

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

Eligibility Criteria
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Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Older Adult)
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
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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
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Responsible Party: David Kudrow, M.D., California Medical Clinic for Headache
ClinicalTrials.gov Identifier: NCT01276977     History of Changes
Other Study ID Numbers: IRUSZOLM0028
First Posted: January 14, 2011    Key Record Dates
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