A Two-Arm Study Evaluation H.P. Acthar Injection Gel in Treatment of Chronic Migraines
Status:
Completed
Trial end date:
2015-11-01
Target enrollment:
Participant gender:
Summary
This small study is to investigate the efficacy of Acthar in the treatment of chronic
migraine in patients who have failed multiple treatments, including Botox (which is defined
as having <30% reduction from baseline in the number of headache days per month). Despite the
widespread use of anti-seizure medications, there remain a significant number of patient
whose migraines are refractory to these agents. The pathophysiology of migraine is such that
the neural substances calcitonin G related protein (CGRP), substance P, and neurokinin A are
released at the trigeminal nerve endings innervating the large cranial and dura mater blood
vessels and this neurotrasmission generates migraine associated pain. Because of this,
treatment for migraine can be directed towards down regulating those receptor sites
accordingly. Acthar may provide pain relief through this mechanist, as ACTH has been shown to
inhibit the release of CGRP and may also provide relief through a negative feedback loop as
exogenous ACTH inhibits CRH release and mast cell degranulation.