Acute Migraine Clinical Trial Announcement

As of February 2017, Dr. Annette Toledano is recruiting patients for an acute migraine clinical trial in her North Miami office.

For more information please visit:

https://clinicaltrials.gov/ct2/show/NCT03061734?term=NCT03061734&rank=1

 

 

 

 

The product under investigation is an investigational combination of two marketed products in a low dose. The components of the combination inhibit two distinct targets in the same molecular pathway resulting in reduction in neuro-inflammation induced pain. We propose that migraine is caused by innate immune system-induced neuro-inflammation near the trigeminal nerve system.

The use of this combination product holds a strong biological rationale, acting synergistically, each component contributes to calming down of two distinct neuro-inflammation producing targets.

Utilizing previously unrecognized properties of the components, the components of the combination inhibits two distinct targets in the same molecular pathway resulting in reduction of neuro-inflammation induced pain. We propose that migraine is caused by innate immune system-induced neuro-inflammation near the trigeminal nerve system.

The use of this combination product holds a strong biological rationale, acting synergistically, each component contributes to calming down of two distinct neuro-inflammation producing targets.

The goal of this study is to establish that the investigational product addresses not only headache pain but also other migraine associated symptoms, especially, nausea. Nausea associated with acute Migraine represents a significant unmet treatment need. Significant efficacy for nausea may suggest that the product’s mechanism of action addresses the fundamental pathogenesis of migraine.