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Zolmitriptan Nasal Spray Versus Eletriptan in the Acute Treatment of Migraine

Primary Purpose

Acute Migraine, Migraine Headache, Headache Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Zolmitriptan 5 mg Nasal Spray
Eletriptan 40 mg tablet
Sponsored by
California Medical Clinic for Headache
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Migraine focused on measuring Migraine, Acute Migraine, Headache

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • California Medical Clinic for Headache

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Zolmitriptan 5 mg nasal spray

Eletriptan 40 mg Tablet

Arm Description

Outcomes

Primary Outcome Measures

Reduction of migraine headache pain from mild, moderate or severe to pain free.

Secondary Outcome Measures

Reduction of migraine headache pain from mild, moderate or severe to pain free.

Full Information

First Posted
January 11, 2011
Last Updated
January 13, 2011
Sponsor
California Medical Clinic for Headache
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1. Study Identification

Unique Protocol Identification Number
NCT01276977
Brief Title
Zolmitriptan Nasal Spray Versus Eletriptan in the Acute Treatment of Migraine
Official Title
Zolmitriptan Nasal Spray VS Eletriptan in the Acute Treatment of Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
California Medical Clinic for Headache

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Migraine, Migraine Headache, Headache Disorders
Keywords
Migraine, Acute Migraine, Headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zolmitriptan 5 mg nasal spray
Arm Type
Experimental
Arm Title
Eletriptan 40 mg Tablet
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Zolmitriptan 5 mg Nasal Spray
Intervention Description
Patients will treat 2 migraine attacks with zolmitriptan 5 mg nasal spray and 2 migraine attacks with eletriptan.
Intervention Type
Drug
Intervention Name(s)
Eletriptan 40 mg tablet
Intervention Description
Patients will treat 2 migraine attacks with Eletriptan and 2 migraine attacks with zolmitriptan 5 mg nasal spray
Primary Outcome Measure Information:
Title
Reduction of migraine headache pain from mild, moderate or severe to pain free.
Time Frame
30 minutes post-dose
Secondary Outcome Measure Information:
Title
Reduction of migraine headache pain from mild, moderate or severe to pain free.
Time Frame
15 minutes post-dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David B Kudrow, MD
Organizational Affiliation
California Medical Clinic for Headache
Official's Role
Principal Investigator
Facility Information:
Facility Name
California Medical Clinic for Headache
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States

12. IPD Sharing Statement

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Zolmitriptan Nasal Spray Versus Eletriptan in the Acute Treatment of Migraine

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