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

What Was Tested

This registered phase 2 trial tested ACTH (Corticotropin) for migraine.

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.

It had two arms (groups): one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 20 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Is male or female, 18 to 60 years of age. Is able to differentiate migraine from any other headache they may experience (e.g., tension-type headache). Will have a previous history of failing at least one prophylactic treatment, which can include anti-seizure medications and/or TCA's prescribed for the treatment of chronic migraine. Will have not had botulinum toxin with in 4 months before study enrollment. Surgically sterile (hysterectomy or tubal ligation or otherwise incapable of pregnancy); or,.

The full record lists 15 inclusion and 12 exclusion criteria; among the exclusions: is unable to understand the study requirements, the informed consent, or complete headache records as required per protocol; is pregnant, actively trying to become pregnant, or breast-feeding; has a progressive neurological disorder such as ms.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The migraine participants were allocated by chance, so the ACTH (Corticotropin) group and the comparison group should start out alike.

The ACTH (Corticotropin) group and the comparison group ran side by side rather than switching.

Everyone knew when ACTH (Corticotropin) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2013-04 with completion listed for 2014-12.

It ran at 4 sites in United States (4).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Average total number of headache days (both [amount hidden] groups).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of ACTH (Corticotropin) in 20 people with migraine.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the ACTH (Corticotropin) compound page, Migraine research.