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Safety and Efficacy of Eletriptan for the Treatment of Migraine in Subjects Unsuccessfully Treated With Nonsteroidal Anti-inflammatory Drugs

Primary Purpose

Migraine

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
eletriptan
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Met International Headache Society diagnostic criteria for migraine with or without aura
  • Expected to suffer one to six acute migraine attacks per month based on past history
  • Experienced migraines for at least one year prior to entering study, and historically have not responded to NSAIDs

Exclusion Criteria:

  • Frequent migraine or frequent concomitant non-migrainous headache (average of >6 attacks per month)
  • Atypical migraines that consistently failed to respond to adequate medical therapy
  • Migraine with prolonged aura, familial hemiplegic migraine, basilar migraine, migrainous infarction, migraine aura without headache, or migraine with acute-onset aura

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

Outcomes

Primary Outcome Measures

Headache severity and response post-treatment
Functional response post-treatment

Secondary Outcome Measures

Presence of associated symptoms including, nausea, vomiting, phonophobia, and photophobia at baseline and post-treatment
Migraine recurrence post-treatment
Time loss (from normal activities and from work) post-treatment
Subject preference and acceptability post-treatment
Subject satisfaction post-treatment
Adverse events
Physical examination
Vital signs
Electrocardiogram
Headache severity and response at baseline and post-treatment
Functional impairment severity and response at baseline and post-treatment

Full Information

First Posted
March 3, 2008
Last Updated
January 26, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00634985
Brief Title
Safety and Efficacy of Eletriptan for the Treatment of Migraine in Subjects Unsuccessfully Treated With Nonsteroidal Anti-inflammatory Drugs
Official Title
A Multicentre, Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Eletriptan 40 Mg for the Treatment of Migraine (With or Without Aura) in Subjects Unsuccessfully Treated With NSAIDS
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To assess the safety and efficacy of eletriptan for the treatment of migraine in subjects who had not been adequately treated with non-steroidal antiinflammatory drugs (NSAIDs)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
eletriptan
Intervention Description
40 mg oral tablet for migraine attack; additional 40 mg oral tablet >2 hours from first dose if migraine reoccurred within 24 hours of achieving response
Primary Outcome Measure Information:
Title
Headache severity and response post-treatment
Time Frame
2 hours
Title
Functional response post-treatment
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Presence of associated symptoms including, nausea, vomiting, phonophobia, and photophobia at baseline and post-treatment
Time Frame
1, 2, 4, and 24 hours
Title
Migraine recurrence post-treatment
Time Frame
1, 2, 4, and 24 hours
Title
Time loss (from normal activities and from work) post-treatment
Time Frame
24 hours
Title
Subject preference and acceptability post-treatment
Time Frame
24 hours and 12 weeks
Title
Subject satisfaction post-treatment
Time Frame
2 and 24 hours
Title
Adverse events
Time Frame
Week 12
Title
Physical examination
Time Frame
Week 12
Title
Vital signs
Time Frame
Week 12
Title
Electrocardiogram
Time Frame
Week 12
Title
Headache severity and response at baseline and post-treatment
Time Frame
1, 4 and 24 hours
Title
Functional impairment severity and response at baseline and post-treatment
Time Frame
1, 4 and 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Met International Headache Society diagnostic criteria for migraine with or without aura Expected to suffer one to six acute migraine attacks per month based on past history Experienced migraines for at least one year prior to entering study, and historically have not responded to NSAIDs Exclusion Criteria: Frequent migraine or frequent concomitant non-migrainous headache (average of >6 attacks per month) Atypical migraines that consistently failed to respond to adequate medical therapy Migraine with prolonged aura, familial hemiplegic migraine, basilar migraine, migrainous infarction, migraine aura without headache, or migraine with acute-onset aura
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Capa
State/Province
Istanbul
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Gaziantep
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Istanbul
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Izmir
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Samsun
Country
Turkey
Facility Name
Pfizer Investigational Site

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1601085&StudyName=Safety%20and%20Efficacy%20of%20Eletriptan%20for%20the%20Treatment%20of%20Migraine%20in%20Subjects%20Unsuccessfuly%20Treated%20with%20Nonsteroidal%20Anti-inflammatory%20Drugs
Description
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Safety and Efficacy of Eletriptan for the Treatment of Migraine in Subjects Unsuccessfully Treated With Nonsteroidal Anti-inflammatory Drugs

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