Efficacy, Safety, and Tolerability of Oral Eletriptan for Treatment of Acute Migraine

NCT01978496

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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
18-78 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- History of at least one typical attack of migraine with or without aura every 6 weeks, as defined by the International Headache Society (IHS) criteria.

- Capable of taking study medication as outpatients and recording its effects.

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


- Pregnant or breast-feeding women


- Migraine subjects who also suffered from concomitant frequent (non-migraine) headache,
defined as more than six headaches per month on average


- Migraine attacks that were thought to be atypical and had consistently failed to
respond to medical therapy.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Efficacy, Safety, and Tolerability of Oral Eletriptan for Treatment of Acute Migraine
Official Title  ICMJE A Multicenter Double-blind, Randomized Placebo Controlled, Parallel Group, Study of the Efficacy and Safety of Oral Eletriptan in Subjects With Acute Migraine
Brief Summary To confirm the efficacy of three dose levels of oral eletriptan relative to placebo in relieving symptoms of acute migraine and to further explore the dose response relationship of eletriptan.
Detailed Description Not 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
    matching placebo
  • Drug: Eletriptan 20 mg
    20mg oral
  • Drug: Eletriptan 40 mg
    40mg oral
  • Drug: Eletriptan 80 mg
    80mg oral
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: Eletriptan 20 mg
    Intervention: Drug: Eletriptan 20 mg
  • 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: October 31, 2013)
1334
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 1997
Actual Primary Completion Date December 1997   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • History of at least one typical attack of migraine with or without aura every 6 weeks, as defined by the International Headache Society (IHS) criteria.
  • Capable of taking study medication as outpatients and recording its effects.

Exclusion Criteria:

  • Pregnant or breast-feeding women
  • Migraine subjects who also suffered from concomitant frequent (non-migraine) headache, defined as more than six headaches per month on average
  • Migraine attacks that were thought to be atypical and had consistently failed to respond to medical therapy.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 78 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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01978496
Other Study ID Numbers  ICMJE A160-102
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP