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THE HEART AND MIGRAINE CONNECTION Retrospective research has shown that a significant number of people who have had PFO closure for health reasons other than migraines have reported a reduction in frequency, or cessation of migraine attacks. For this reason, further knowledge on the relationship between PFO and migraine is being sought.
The Premium Trial is designed to evaluate the effectiveness of PFO closure as a treatment for migraine. PFO closure is performed by placing an occlusion device into the PFO through a catheter in a catheterization laboratory setting. Approximately 466 patients will be enrolled in the Premium Trial at 35 sites around the US. TRIAL DESIGN The trial is a prospective, randomized, sham-controlled, double blind, multi-center study to evaluate safety and efficacy. RANDOMIZATION ARMS Closure of the PFO with the AMPLATZER® PFO Occluder and standard of care medical treatment, or standard of care medical treatment only. PATIENT POPULATION Patients 18-55 years of age with migraine (with or without aura) reported to have a 3 month retrospective history of 6-14 headache days per month and who also demonstrate the same during a one month baseline phase; failure/refractory/unresponsive to two previous commonly accepted medication treatments; and demonstrated presence of PFO with significant shunt (greater than or equal to grade 5 with Transcranial Doppler). Other inclusion and exclusion criteria must be met to qualify for the Trial. Contact AGA Medical or a Trial site for more information. |
BASELINE TESTING (INCLUDED, BUT NOT LIMITED TO) Initial testing for inclusion in the Trial includes: Medical history, 1 month headache diary, quality-of-life questionnaire, depression (BDI) and migraine disability assessment (MIDAS) survey, clinical neurological assessment, routine blood workup, EKG, and Transcranial Doppler (TCD) evaluation for PFO. FOLLOW-UP Patients will keep a headache diary and be evaluated by the investigating neurologist every month for six months following randomization, and every other month for the following six months. END POINTS Comparison of reduction in the number of reported headache attacks between the baseline phase and treatment phase in both groups. LOCATE A PREMIUM TRIAL SITE To locate trial sites in your area and for more information on the Premium Trial, please complete the Premium Information form here. You will receive a listing of sites, and referring physician information about the Premium Trial. Please send me a clinical trial site listing and additional information about the Premium Trial. |
