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

Last updated on November 19, 2019

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Study Location
Arhus Kommunehospital
Arhus C, , 8000 Denmark
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Migraine With or Without Aura
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-68 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01989936
Pfizer
Completed
Eletriptan for the Treatment of Migraine in Patients With Previous Poor Response or Tolerance to Oral Sumatriptan

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Descriptive Information
Brief Title  ICMJE Eletriptan for the Treatment of Migraine in Patients With Previous Poor Response or Tolerance to Oral Sumatriptan
Official Title  ICMJE 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
Brief SummaryTo 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).
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Migraine With or Without Aura
Intervention  ICMJE
  • 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.
  • Drug: 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.
  • Drug: 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.
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: Eletriptan 40 mg
    Intervention: Drug: Eletriptan 40 mg
  • Experimental: Eletriptan 80 mg
    Intervention: Drug: Eletriptan 80 mg
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 20, 2013)
446
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2000
Actual Primary Completion DateSeptember 2000   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 68 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark,   Finland,   Netherlands,   Norway,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01989936
Other Study ID Numbers  ICMJE A1601006
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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