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.

First Received: September 9, 2005 Last Updated: October 31, 2007 History of Changes

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00174395

Purpose

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
Migraine	Drug: eletriptan	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
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:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Migraine

Drug Information available for: Eletriptan Eletriptan Hydrobromide

U.S. FDA Resources

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

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00174395

Show 33 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	A1601107
Study First Received:	September 9, 2005
Last Updated:	October 31, 2007
ClinicalTrials.gov Identifier:	NCT00174395 History of Changes
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

Serotonin Agonists
Eletriptan
Neurotransmitter Agents
Migraine Disorders
Headache
Central Nervous System Diseases

Headache Disorders, Primary
Pain
Brain Diseases
Serotonin
Headache Disorders

Additional relevant MeSH terms:

Eletriptan
Serotonin Agonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Central Nervous System Diseases

Headache Disorders, Primary
Brain Diseases
Pharmacologic Actions
Headache Disorders
Serotonin Agents
Migraine Disorders

ClinicalTrials.gov processed this record on September 02, 2009