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Sponsored by: |
Thomas Jefferson University |
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Information provided by: | Thomas Jefferson University |
ClinicalTrials.gov Identifier: | NCT00443352 |
This is a single-center, open-label, pilot trial to collect and evaluate data on the safety and efficacy of duloxetine in the preventive treatment of subjects experiencing episodic migraine headaches. Following a 28-day baseline period, qualifying subjects will be entered into an 84-day treatment period. Subjects will be titrated over the first four weeks to a dose of 120mg or their maximally tolerated dose (MTD). The dose adjustments will be based on individual subject response and/or subject's tolerability. Subjects will maintain a daily diary capturing detailed information on migraine headache days.
Condition | Intervention |
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Migraine |
Drug: Duloxetine |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Single-Center, Open Label Pilot Study Examining The Use Of Duloxetine In The Prevention Of Episodic Migraine |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
EXCLUSION CRITERIA:
Contact: Meryl Latsko, MD, MPH | 215-955-9477 | meryl.latsko@jefferson.edu |
United States, Pennsylvania | |
Jefferson Headache Center | Recruiting |
Philadelphia, Pennsylvania, United States, 19107 | |
Contact: Meryl Latsko, MD, MPH 215-955-9477 Meryl.Latsko@jefferson.edu | |
Principal Investigator: William B. Young, MD |
Principal Investigator: | William B. Young, MD | Thomas Jefferson University |
Study ID Numbers: | Protocol #: F1J-MC-I |
Study First Received: | March 5, 2007 |
Last Updated: | January 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00443352 History of Changes |
Health Authority: | United States: Institutional Review Board |
Dopamine Uptake Inhibitors Neurotransmitter Agents Adrenergic Agents Psychotropic Drugs Central Nervous System Diseases Headache Disorders, Primary Brain Diseases Serotonin Uptake Inhibitors |
Duloxetine Serotonin Headache Disorders Dopamine Migraine Disorders Headache Dopamine Agents Antidepressive Agents |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Adrenergic Uptake Inhibitors Physiological Effects of Drugs Nervous System Diseases Psychotropic Drugs Central Nervous System Diseases Headache Disorders, Primary |
Brain Diseases Serotonin Uptake Inhibitors Duloxetine Pharmacologic Actions Headache Disorders Serotonin Agents Migraine Disorders Therapeutic Uses Dopamine Agents Central Nervous System Agents Antidepressive Agents |