Migraine Clinical Trials

We are currently enrolling in the Premium II trial (“a randomized, multicenter, double-blind, parallel, sham-controlled study of non-invasive vagus nerve stimulation (nvns) for the prevention of migraines”). This is a study testing a device called gammaCore Sapphire, a non-invasive vagus nerve stimulator, for the prevention of migraines. It is currently cleared by the FDA for use of treatment of episodic cluster headaches and migraines in adults, but in this study is being used to see if daily use can prevent migraines. This study has a four-week “run-in” period which will allow the study team to establish a baseline of the patient’s migraine history. This will be followed by a 12-week randomized period in which the patient will either be randomized to active treatment with the gammaCore Sapphire or a sham, inactive device.

You may qualify for this study if:

  • You are between the ages of 18 and 75
  • You have been diagnosed with migraine and have between 8 and 20 migraines per month
  • You do not have certain medical conditions or medical history such as stroke, brain tumor, brain aneurysm, seizure or uncontrolled high blood pressure

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