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Eletriptan for the Treatment of Migraine in Patients With Previous Poor Response or Tolerance to Oral Sumatriptan

Primary Purpose

Migraine With or Without Aura

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Eletriptan 40 mg
Eletriptan 80 mg
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 With or Without Aura

Eligibility Criteria

18 Years - 68 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and female subjects age ≥ 18 years who met the International Headache Society (IHS) diagnostic criteria for migraine, with or without aura, and could reasonably expect to suffer at least one acute attack of migraine every 6 weeks.
  • Subjects required to have discontinued therapy with oral sumatriptan at least 2 weeks, but not longer than 2 years, prior to the screening visit.
  • Female subjects required to be adequately protected against pregnancy.

Exclusion Criteria:

  • pregnancy or breastfeeding, known coronary artery disease, significant arrhythmias, heart failure, significant ECG abnormalities, and uncontrolled hypertension.
  • Any significant systemic, organ, neurological, endocrine, metabolic, and psychological disorders reported by the patient or discovered during the physical examination
  • Subjects considered to have atypical migraine such as frequent attacks, prolonged aura or any migraine that was considered atypical.
  • Subjects who, during the course of the trial, required treatment with sumatriptan or any other 5-HT1B/1D agonist in addition to study medication.

Sites / Locations

  • Arhus Kommunehospital
  • Centralsygehuset I Esbjerg
  • Kas Glostrup
  • Hilleroed Sygehus
  • Knud Kjaersgaard Pedersen
  • Bispebjerg Hospital
  • Neubauer, Ole (Private Practice)
  • Korsgaard, Anne G. (Private Practice)
  • Haukiputaan Laakarikeskus
  • Helsinki University Central Hospital
  • Hyvinkaa District Hospital
  • Torikeskuksen Laakariasema
  • Mikkelin Paansarkypoliklinikka (Mikkeli Headache)
  • Porin Laakarikeskus
  • Turku Headache Centre
  • Bosch Medicentrum (Locatie Willem Alexander Ziekenhuis)
  • Sint Lucas Andreas Ziekenhuis (Location: St.Lucas)
  • Sentralsykehuset I Akershus
  • Private Practice, Oyvind Rosjo
  • Volvat Medisinske Senter
  • Strandquist, Dr. Stein Bror
  • Migranklinik-Goeteborg
  • Neurologsektionen, Lasarettet
  • Neuro Kliniken, Helsingborg
  • Medicin Kliniken, Sjukhuset
  • Medicin Kliniken, Universitetssjukhuset
  • St Gorans Sjukhus
  • Kronobergskliniken
  • Danderydssjukhus
  • Foretagshalsovarden Linden
  • Fylkessjukehuset I Molde
  • Huslakargruppen
  • Lakarhuset Hermelinen
  • Lakarhuset
  • Limhamns Lakargrupp, Tarnan
  • Lundsbysjukhus
  • Medicinskt Centrum
  • Nijmeegs Interkonfessioneel Ziekenhuis Canisius-Wilhelmina
  • Primarvarden
  • Regionsykehuset I Trondheim
  • Sentralsjukehuset I Hedmark
  • Sint Anna Ziekenhuis
  • Vardcentralen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Eletriptan 40 mg

Eletriptan 80 mg

Arm Description

Outcomes

Primary Outcome Measures

The primary efficacy endpoint was 2-h headache response after taking the first dose of study medication for the first attack
Subjects recorded the intensity of each migraine headache in the diary based on a 4-point scale: 0, pain absent; 1, mild pain; 2, moderate pain; 3, severe pain. A response was considered a change from severe or moderate pain to mild or absent at various time points after dosing with study medication

Secondary Outcome Measures

Sustained response was defined as achieving a headache response within 2 h post dose, with no recurrence or rescue medication needed
Recurrence was defined as a return of headache to moderate or severe intensity within 2-24 h if the subject had an initial response within 2 h of taking the study medication.

Full Information

First Posted
October 30, 2013
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
NCT01989936
Brief Title
Eletriptan for the Treatment of Migraine in Patients With Previous Poor Response or Tolerance to Oral Sumatriptan
Official Title
A Multicenter, Double - Blind, Randomized, Placebo - Controlled Parallel Group Study of the Efficacy and Safety of Oral Eletriptan (40 and 80mg) Given for the Treatment of Acute Migraine in Subjects Discontinued From Oral Sumatriptan
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 1999 (undefined)
Primary Completion Date
September 2000 (Actual)
Study Completion Date
September 2000 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To determine the tolerability and efficacy of eletriptan in patients who had discontinued oral sumatriptan due to lack of efficacy or intolerable adverse events (AEs) during previous clinical treatment (not a controlled trial).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine With or Without Aura

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
446 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Eletriptan 40 mg
Arm Type
Experimental
Arm Title
Eletriptan 80 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subjects were randomized to one of the 3 treatment groups (eletriptan 40 mg, eletriptan 80 mg, or placebo) in a 2:2:1 ratio and were given sufficient medication to treat 3 migraine attacks (including a second dose for each attack for recurrence) within 18 weeks of the initial visit. Subjects were instructed to treat a moderate to severe migraine within 6 hours of the onset of pain provided the headache was not decreasing in severity, the aura phase had ended and they had taken no analgesic or antiemetic within 6 hours. Efficacy data was collected in a diary. Subjects were allowed to take rescue medication if they had no response to the study medication within 4 hours of onset.
Intervention Type
Drug
Intervention Name(s)
Eletriptan 40 mg
Intervention Description
Subjects were randomized to one of the 3 treatment groups (eletriptan 40 mg, eletriptan 80 mg, or placebo) in a 2:2:1 ratio and were given sufficient medication to treat 3 migraine attacks (including a second dose for each attack for recurrence) within 18 weeks of the initial visit. Subjects were instructed to treat a moderate to severe migraine within 6 hours of the onset of pain provided the headache was not decreasing in severity, the aura phase had ended and they had taken no analgesic or antiemetic within 6 hours. Efficacy data was collected in a diary. Subjects were allowed to take rescue medication if they had no response to the study medication within 4 hours of onset.
Intervention Type
Drug
Intervention Name(s)
Eletriptan 80 mg
Intervention Description
Subjects were randomized to one of the 3 treatment groups (eletriptan 40 mg, eletriptan 80 mg, or placebo) in a 2:2:1 ratio and were given sufficient medication to treat 3 migraine attacks (including a second dose for each attack for recurrence) within 18 weeks of the initial visit. Subjects were instructed to treat a moderate to severe migraine within 6 hours of the onset of pain provided the headache was not decreasing in severity, the aura phase had ended and they had taken no analgesic or antiemetic within 6 hours. Efficacy data was collected in a diary. Subjects were allowed to take rescue medication if they had no response to the study medication within 4 hours of onset.
Primary Outcome Measure Information:
Title
The primary efficacy endpoint was 2-h headache response after taking the first dose of study medication for the first attack
Description
Subjects recorded the intensity of each migraine headache in the diary based on a 4-point scale: 0, pain absent; 1, mild pain; 2, moderate pain; 3, severe pain. A response was considered a change from severe or moderate pain to mild or absent at various time points after dosing with study medication
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
Sustained response was defined as achieving a headache response within 2 h post dose, with no recurrence or rescue medication needed
Description
Recurrence was defined as a return of headache to moderate or severe intensity within 2-24 h if the subject had an initial response within 2 h of taking the study medication.
Time Frame
18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female subjects age ≥ 18 years who met the International Headache Society (IHS) diagnostic criteria for migraine, with or without aura, and could reasonably expect to suffer at least one acute attack of migraine every 6 weeks. Subjects required to have discontinued therapy with oral sumatriptan at least 2 weeks, but not longer than 2 years, prior to the screening visit. Female subjects required to be adequately protected against pregnancy. Exclusion Criteria: pregnancy or breastfeeding, known coronary artery disease, significant arrhythmias, heart failure, significant ECG abnormalities, and uncontrolled hypertension. Any significant systemic, organ, neurological, endocrine, metabolic, and psychological disorders reported by the patient or discovered during the physical examination Subjects considered to have atypical migraine such as frequent attacks, prolonged aura or any migraine that was considered atypical. Subjects who, during the course of the trial, required treatment with sumatriptan or any other 5-HT1B/1D agonist in addition to study medication.
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
Arhus Kommunehospital
City
Arhus C
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Centralsygehuset I Esbjerg
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
Facility Name
Kas Glostrup
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Hilleroed Sygehus
City
Hilleroed
ZIP/Postal Code
3400
Country
Denmark
Facility Name
Knud Kjaersgaard Pedersen
City
Hjorring
ZIP/Postal Code
9800
Country
Denmark
Facility Name
Bispebjerg Hospital
City
København
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Neubauer, Ole (Private Practice)
City
Nykoebing F
ZIP/Postal Code
4800
Country
Denmark
Facility Name
Korsgaard, Anne G. (Private Practice)
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Haukiputaan Laakarikeskus
City
Haukipudas
ZIP/Postal Code
90830
Country
Finland
Facility Name
Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
Hyvinkaa District Hospital
City
Hyvinkaa
ZIP/Postal Code
05850
Country
Finland
Facility Name
Torikeskuksen Laakariasema
City
Jyvaskyla
ZIP/Postal Code
40100
Country
Finland
Facility Name
Mikkelin Paansarkypoliklinikka (Mikkeli Headache)
City
Mikkeli
ZIP/Postal Code
50100
Country
Finland
Facility Name
Porin Laakarikeskus
City
Pori
ZIP/Postal Code
28100
Country
Finland
Facility Name
Turku Headache Centre
City
Turku
ZIP/Postal Code
20110
Country
Finland
Facility Name
Bosch Medicentrum (Locatie Willem Alexander Ziekenhuis)
City
's-hertogenbosch
ZIP/Postal Code
5223GV
Country
Netherlands
Facility Name
Sint Lucas Andreas Ziekenhuis (Location: St.Lucas)
City
Amsterdam
ZIP/Postal Code
1061 AE
Country
Netherlands
Facility Name
Sentralsykehuset I Akershus
City
Nordbyhagen
ZIP/Postal Code
1474
Country
Norway
Facility Name
Private Practice, Oyvind Rosjo
City
Oslo
ZIP/Postal Code
0166
Country
Norway
Facility Name
Volvat Medisinske Senter
City
Oslo
ZIP/Postal Code
0303
Country
Norway
Facility Name
Strandquist, Dr. Stein Bror
City
Tonsberg
ZIP/Postal Code
3111
Country
Norway
Facility Name
Migranklinik-Goeteborg
City
Goeteborg
ZIP/Postal Code
SE-411 17
Country
Sweden
Facility Name
Neurologsektionen, Lasarettet
City
Helsingborg
ZIP/Postal Code
251 87
Country
Sweden
Facility Name
Neuro Kliniken, Helsingborg
City
Helsingborg
ZIP/Postal Code
25221
Country
Sweden
Facility Name
Medicin Kliniken, Sjukhuset
City
Kristinehamn
ZIP/Postal Code
681 80
Country
Sweden
Facility Name
Medicin Kliniken, Universitetssjukhuset
City
Lund
ZIP/Postal Code
22185
Country
Sweden
Facility Name
St Gorans Sjukhus
City
Stockholm
ZIP/Postal Code
SE-112 81
Country
Sweden
Facility Name
Kronobergskliniken
City
Vaexjoe
ZIP/Postal Code
SE-352 34
Country
Sweden
Facility Name
Danderydssjukhus
Facility Name
Foretagshalsovarden Linden
Facility Name
Fylkessjukehuset I Molde
Facility Name
Huslakargruppen
Facility Name
Lakarhuset Hermelinen
Facility Name
Lakarhuset
Facility Name
Limhamns Lakargrupp, Tarnan
Facility Name
Lundsbysjukhus
Facility Name
Medicinskt Centrum
Facility Name
Nijmeegs Interkonfessioneel Ziekenhuis Canisius-Wilhelmina
Facility Name
Primarvarden
Facility Name
Regionsykehuset I Trondheim
Facility Name
Sentralsjukehuset I Hedmark
Facility Name
Sint Anna Ziekenhuis
Facility Name
Vardcentralen

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1601006&StudyName=Eletriptan%20for%20the%20Treatment%20of%20Migraine%20in%20Patients%20with%20Previous%0APoor%20Response%20or%20Tolerance%20to%20Oral%20Sumatriptan
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Eletriptan for the Treatment of Migraine in Patients With Previous Poor Response or Tolerance to Oral Sumatriptan

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