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Sponsors and Collaborators: |
Thomas Jefferson University Valeant Pharmaceuticals International |
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Information provided by: | Thomas Jefferson University |
ClinicalTrials.gov Identifier: | NCT00203268 |
This is a research study examining a migraine medicine called DHE-45.It will be used to treat two migraine attacks in subjects who have a history of skin sensitivity associated with their headaches.This skin sensitivity is called cutaneous allodynia (pronounced q-tay-nee-us al-o-din-ee-uh).It has been noted in several studies that in subjects with migraine, seventy nine percent of the subjects experienced allodynia on the facial skin on the same side as the headache. It has also been shown that that once allodynia develops, other migraine medicines that would normally be very effective for migraine pain, become much less effective or ineffective. This study will compare the differences,if any, in attacks treated early with this study drug and treated later with the same study drug. It is hoped that that this trial will provide information on the use of DHE-45 in subjects who have cutaneous allodynia. Understanding more about allodynia may help us understand how the pain system works in migraine.
Condition | Intervention |
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Migraine Cutaneous Allodynia |
Drug: dihydroergotamine mesylate |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | An Open Label Pilot Trial to Collect and Evaluate Data on the Use of Dihydroergotamine Mesylate in the Treatment of Two Migraine Attacks Associated With Cutaneous Allodynia |
Estimated Enrollment: | 10 |
Study Start Date: | December 2003 |
Estimated Study Completion Date: | March 2005 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
Jefferson Headache Center | |
Philadelphia, Pennsylvania, United States, 19107 |
Principal Investigator: | Stephen D Silberstein, MD | Thomas Jefferson University, Jefferson Headache Center |
Study ID Numbers: | SDS/DHE/01 |
Study First Received: | September 13, 2005 |
Last Updated: | January 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00203268 History of Changes |
Health Authority: | United States: Food and Drug Administration |
migraine cutaneous allodynia |
Neurotransmitter Agents Central Nervous System Diseases Headache Disorders, Primary Dihydroergotamine Cardiovascular Agents Brain Diseases Dopamine Agonists Headache Disorders |
Dopamine Migraine Disorders Analgesics, Non-Narcotic Headache Vasoconstrictor Agents Dopamine Agents Peripheral Nervous System Agents Analgesics |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Central Nervous System Diseases Headache Disorders, Primary Dihydroergotamine Cardiovascular Agents Brain Diseases Dopamine Agonists Pharmacologic Actions |
Headache Disorders Sensory System Agents Analgesics, Non-Narcotic Migraine Disorders Therapeutic Uses Vasoconstrictor Agents Dopamine Agents Peripheral Nervous System Agents Analgesics Central Nervous System Agents |