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Trial record 13 of 179 for:    Migraine AND migraine with or without aura

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

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ClinicalTrials.gov Identifier: NCT01978496
Recruitment Status : Completed
First Posted : November 7, 2013
Last Update Posted : November 13, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Migraine With or Without Aura Drug: Placebo Drug: Eletriptan 20 mg Drug: Eletriptan 40 mg Drug: Eletriptan 80 mg Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1334 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter Double-blind, Randomized Placebo Controlled, Parallel Group, Study of the Efficacy and Safety of Oral Eletriptan in Subjects With Acute Migraine
Study Start Date : July 1996
Actual Primary Completion Date : December 1997
Actual Study Completion Date : December 1997

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
matching placebo

Experimental: Eletriptan 20 mg Drug: Eletriptan 20 mg
20mg oral

Experimental: Eletriptan 40 mg Drug: Eletriptan 40 mg
40mg oral

Experimental: Eletriptan 80 mg Drug: Eletriptan 80 mg
80mg oral




Primary Outcome Measures :
  1. Headache responder rate at two hours after the first dose for the first attack. [ Time Frame: 2 hours ]
    A headache response was defined as a subject having improvement in headache severity from grade 2 or 3 at baseline to 0 or 1 at two hours post-dose.


Secondary Outcome Measures :
  1. Pain free responder rate at two hours after the first dose for the first attack. [ Time Frame: 2 hours ]
    Pain free response was defined as improvement from grade 2 or 3 at baseline to grade 0 at two hours post-dose.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 78 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01978496


Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01978496     History of Changes
Other Study ID Numbers: A160-102
First Posted: November 7, 2013    Key Record Dates
Last Update Posted: November 13, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Eletriptan
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs