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

Migraine With or Without Aura Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01989936
• Other study ID #: A1601006
• Status: Completed
• Phase: Phase 3
• Start date: January 1999
• Est. completion date: September 2000

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 446
• Est. completion date: September 2000
• Est. primary completion date: September 2000
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 68 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine Disorders
• Migraine With or Without Aura

Intervention

Drug:
• Placebo
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.
• Eletriptan 40 mg
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.
• Eletriptan 80 mg
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.

Locations

Country	Name	City	State
	Danderydssjukhus
	Foretagshalsovarden Linden
	Fylkessjukehuset I Molde
	Huslakargruppen
	Lakarhuset
	Lakarhuset Hermelinen
	Limhamns Lakargrupp, Tarnan
	Lundsbysjukhus
	Medicinskt Centrum
	Nijmeegs Interkonfessioneel Ziekenhuis Canisius-Wilhelmina
	Primarvarden
	Regionsykehuset I Trondheim
	Sentralsjukehuset I Hedmark
	Sint Anna Ziekenhuis
	Vardcentralen
Denmark	Arhus Kommunehospital	Arhus C
Denmark	Centralsygehuset I Esbjerg	Esbjerg
Denmark	Kas Glostrup	Glostrup
Denmark	Hilleroed Sygehus	Hilleroed
Denmark	Knud Kjaersgaard Pedersen	Hjorring
Denmark	Bispebjerg Hospital	København
Denmark	Neubauer, Ole (Private Practice)	Nykoebing F
Denmark	Korsgaard, Anne G. (Private Practice)	Odense C
Finland	Haukiputaan Laakarikeskus	Haukipudas
Finland	Helsinki University Central Hospital	Helsinki
Finland	Hyvinkaa District Hospital	Hyvinkaa
Finland	Torikeskuksen Laakariasema	Jyvaskyla
Finland	Mikkelin Paansarkypoliklinikka (Mikkeli Headache)	Mikkeli
Finland	Porin Laakarikeskus	Pori
Finland	Turku Headache Centre	Turku
Netherlands	Bosch Medicentrum (Locatie Willem Alexander Ziekenhuis)	's-hertogenbosch
Netherlands	Sint Lucas Andreas Ziekenhuis (Location: St.Lucas)	Amsterdam
Norway	Sentralsykehuset I Akershus	Nordbyhagen
Norway	Private Practice, Oyvind Rosjo	Oslo
Norway	Volvat Medisinske Senter	Oslo
Norway	Strandquist, Dr. Stein Bror	Tonsberg
Sweden	Migranklinik-Goeteborg	Goeteborg
Sweden	Neuro Kliniken, Helsingborg	Helsingborg
Sweden	Neurologsektionen, Lasarettet	Helsingborg
Sweden	Medicin Kliniken, Sjukhuset	Kristinehamn
Sweden	Medicin Kliniken, Universitetssjukhuset	Lund
Sweden	St Gorans Sjukhus	Stockholm
Sweden	Kronobergskliniken	Vaexjoe

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

Denmark,  Finland,  Netherlands,  Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	18 weeks
Secondary	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.	18 weeks

External Links

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