Ignite Creation Date:
2024-05-06 @ 1:27 AM
Last Modification Date:
2024-10-26 @ 11:04 AM
Study NCT ID:
NCT01813591
Status:
COMPLETED
Last Update Posted:
2018-07-26
First Post:
2013-03-15
Brief Title:
A Two-Arm Study Evaluation HP Acthar Injection Gel in Treatment of Chronic Migraines
Sponsor:
Dent Neuroscience Research Center
Organization:
Dent Neuroscience Research Center
Study Overview
Official Title:
A Randomized Open-Label Parallel Two-Arm Study Evaluating the Efficacy of HP Acthar Injection Gel in the Treatment of Adults With Intractable Chronic Migraine
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None