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

Last updated on December 16, 2017

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Study Location
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
18-78 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.

NCT01978496
Pfizer
Completed
Efficacy, Safety, and Tolerability of Oral Eletriptan for Treatment of Acute Migraine

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Efficacy, Safety, and Tolerability of Oral Eletriptan for Treatment of Acute Migraine
A Multicenter Double-blind, Randomized Placebo Controlled, Parallel Group, Study of the Efficacy and Safety of Oral Eletriptan in Subjects With Acute Migraine
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Migraine With or Without Aura
  • Drug: Placebo
    matching placebo
  • Drug: Eletriptan 20 mg
    20mg oral
  • Drug: Eletriptan 40 mg
    40mg oral
  • Drug: Eletriptan 80 mg
    80mg oral
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1334
December 1997
December 1997   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 78 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01978496
A160-102
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2013

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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