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A Trial to Study of the Effects of Eletriptan 40mg on Mild vs Moderate to Severe Pain Intensity of Migraine

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: September 9, 2005
Last updated: October 31, 2007
Last verified: October 2007
To evaluate the efficacy of early intervention (dosing within 2 hours of onset of the migraine attack) with eletriptan 40mg on mild versus moderate to severe pain intensity of migraine.

Condition Intervention Phase
Drug: eletriptan
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Center, Open-Label, Randomized, Parallel-Group Study of the Effects of Eletriptan 40mg on Mild vs Moderate to Severe Pain Intensity of Migraine in Early Intervention.

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • To evaluate pain free response at 2 hours with eletriptan 40mg in mild pain compared to moderate to severe pain intensity of migraine in early intervention.

Secondary Outcome Measures:
  • To demonstrate the efficacy of early intervention with eletriptan 40mg on mild compared to moderate to severe migraine pain include the following clinical outcomes: pain-free at 0.5, 1, 1.5, 4 and 24 hours; sustained pain-free, migraine recurrence

Estimated Enrollment: 220
Study Start Date: March 2005
Study Completion Date: October 2006

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of migraine with or without aura according to the recent IHS criteria.
  • Migraine headaches must have been present for more than one year.
  • History in the last 3 months of 1 to 4 acute attacks of migraine headache per month.

Exclusion Criteria:

  • Subjects with current or past history of coronary artery disease.
  • Pregnant or breastfeeding women.
  • Subjects who have chronic daily headaches.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00174395

  Show 33 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information: Identifier: NCT00174395     History of Changes
Other Study ID Numbers: A1601107
Study First Received: September 9, 2005
Last Updated: October 31, 2007

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on May 25, 2017