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Sponsored by: |
Thomas Jefferson University |
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Information provided by: | Thomas Jefferson University |
ClinicalTrials.gov Identifier: | NCT00335777 |
This is a research study looking at Migranal (study drug) in the treatment of two migraine attacks in patients who have a history of cutaneous allodynia (pronounced q-tay-nee-us al-o-din-ee-a). Cutaneous allodynia is an increased skin sensitivity experienced during a headache. It has been noted in several studies that in patients with migraine, seventy nine percent of the patients experienced allodynia on the facial skin on the same side as the headache. Understanding more about allodynia may help us understand how the pain system works in migraine.
This study will compare the differences, if any, in attacks treated early with study drug (at 1-hour from onset) and attacks treated later (at 4-hours). You will be asked to treat one attack early and one attack late for this study. If the first attack you treat is early (at 1 hour following onset of throbbing pain) then the second attack you treat should be late (at 4 hours following onset of throbbing pain).
It is hoped that this study will provide information on the use of Migranal in subjects who have cutaneous allodynia. The results from this study may be used in the development of larger clinical trials. The study drug is a medication that is taken in the form of nasal spray.
Condition | Intervention | Phase |
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Migraine |
Drug: Migranal |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label Pilot Trial To Collect And Evaluate Data On The Use Of Migranal® In The Treatment Of Two Acute Migraine Attacks Associated With Cutaneous Allodynia |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Aamir Hussain, M.D. | 215-955-2243 | aamirgul@gmail.com |
Contact: Cheryl Gebeline-Myers, B.S., CRCC | 215-955-2243 | cheryl.gebeline-myers@jefferson.edu |
United States, Pennsylvania | |
Jefferson Headache Center | Recruiting |
Philadelphia, Pennsylvania, United States, 19107 | |
Principal Investigator: Stephen D. Silberstein, M.D. |
Principal Investigator: | Stephen D. Silberstein, M.D. | Jefferson Headache Center |
Study ID Numbers: | SDS/MIG-CA/ 01 |
Study First Received: | June 9, 2006 |
Last Updated: | October 11, 2006 |
ClinicalTrials.gov Identifier: | NCT00335777 |
Health Authority: | United States: Institutional Review Board |
Dopamine Migraine Disorders Headache Central Nervous System Diseases |
Dihydroergotamine Headache Disorders, Primary Brain Diseases Headache Disorders |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Cardiovascular Agents Dopamine Agonists Pharmacologic Actions Analgesics, Non-Narcotic |
Sensory System Agents Therapeutic Uses Vasoconstrictor Agents Dopamine Agents Analgesics Peripheral Nervous System Agents Central Nervous System Agents |