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
  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:


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

ClinicalTrials.gov processed this record on April 14, 2014