NCT01813591

A Two-Arm Study Evaluation H.P. Acthar Injection Gel in Treatment of Chronic Migraines

A Randomized, Open-Label, Parallel Two-Arm Study Evaluating the Efficacy of H.P. Acthar Injection Gel in the Treatment of Adults With Intractable Chronic Migraine

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Dent Neuroscience Research Center · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Migraine

Interventions

Type	Name	Description
DRUG	H.P. Acthar Gel	Acthar (40IU or 80IU) given subcutaneously for 5 days in the 1st week, followed by every other day (3 times per week for the next 3 weeks)

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-12-01
• Completion: 2015-11-01
• First posted: 2013-03-19
• Last updated: 2018-07-26

Locations

4 sites across 1 country: United States