Clinical Trial for a New Acute Treatment for Migraine
We are seeking patients with 1 to 8 days of migraine headaches per month and who currently treat their migraines with Fioricet® and/or other butalbital-containing combination medications (BCM) to participate in a research study evaluating TreximaTM, a new investigational medication for the acute treatment of migraine. BCMs and other barbiturates are among the most commonly prescribed medications for the treatment of migraine headaches; however, they are often associated with many serious and undesirable side effects. Participants in this study will be asked to treat 3 separate migraine attacks within a 19 week period with one of three study medications: TreximaTM, a BCM, or placebo. Qualified participants will receive all study-related care at no charge. Reimbursement for time and travel may also be available.
For more information, please contact our research coordinators at (718) 405-8007. Principal Investigator: Brian Grosberg, MD; IRB#: 07-02-268-01; IRB approved through 2/13/2009.
Pilot Study Evaluating the Safety and Effectiveness of BOTOX® in the Treatment of Patients with Chronic Migraine and Co-Morbid Depressive Disorders
Migraine has been linked to depression, anxiety, and other mental health issues. Some studies suggest that migraine may provoke depression, or alternatively that a depressed mood and the associated tension may precipitate migraine attacks. The primary objective of this study is to determine the safety and effectiveness of BOTOX® injections when used as a preventative treatment in patients who suffer from chronic migraine and associated depressive disorders. Recent clinical studies do suggest that BOTOX® may be capable of preventing migraine attacks, but this is not yet conclusively proven. Also being assessed, is whether or not fewer headaches will translate into less severe depressive symptoms. The Montefiore Headache Center is seeking patients with 15 or more days of migraine a month and have a current diagnosis of a Mood Disorder to participate in this study. The study duration is approximately 28 weeks in which patients will receive two consecutive treatments of BOTOX® 12 weeks apart. In addition, psychological and emotional functioning will be assessed and monitored at every visit. Qualified participants will receive all study-related care at no charge. Reimbursement for time and travel may also be available.
For more information, please contact our research coordinators at (718) 405-8007 or email headacheresearch@gmail.com
Principal Investigator:
Brian Grosberg, MD
Montefiore Headache Center
1575 Blondell Avenue, Suite 225
Bronx, New York, 10461
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