A Two-Arm Study Evaluation H.P. Acthar Injection Gel in Treatment of Chronic Migraines
CompletedPhase 2NCT01813591
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- 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
- Conditions
- Interventions
- Drug: H.P. Acthar Gel
- Sponsor
- Dent Neuroscience Research Center
- Start date
- 2013-04
- Primary completion
- 2014-12
- Sex
- All
- Age range
- from 18 Years to 60 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 4
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Is male or female, 18 to 60 years of age. * Has a history of chronic migraine as classified by the International Headache Classification, ICHD-2R (i.e. must demonstrate an average of \>=15 headache days per month, of which \>=8 must be migraine days or \>=8 days of migraine-specific acute medication-ergotamine or triptans for at least 3 months prior to study. * Must demonstrate at least \>=8 migraine days or \>=8 days of migraine specific acute medications- ergotamine or triptans during 30 day baseline screening. * 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. * Must be considered a non-responder to previous treatment with Botox. Botox failure will be defined by previous documentation (at the discretion of the PI) or as having less than 30% reduction of headache days per month on Botox. * Will have not had botulinum toxin with in 4 months before study enrollment. * If female of childbearing potential, will have a negative urine pregnancy test at Visits 1 and 7, and uses, or agrees to use, for the duration of the study, a medically acceptable form of contraception as determined by the investigator. 1. Complete abstinence from intercourse from 2 weeks prior to administration of study drug throughout the study, and for a time interval after completion or premature discontinuation from the study to account for elimination of the study drug (a minimum of 7 days); or, 2. Surgically sterile (hysterectomy or tubal ligation or otherwise incapable of pregnancy); or, 3. Sterilization of male partner; or, 4. Intrauterine device with published data showing lowest expected failure rate is less than 1% per year; or, 5. Double barrier method (i.e., 2 physical barriers OR 1 physical barrier plus spermicide) for a least 1 month prior to Visit 1 and throughout study; or, 6. Hormonal contraceptives for at least 3 months prior to Visit 1 and throughout study. Protocol Number/v.1/06 Jun 2012 7 * Must be in generally good health as confirmed by medical history, baseline physical exam, baseline neurological exam and vital signs. Exclusion Criteria: * Is unable to understand the study requirements, the informed consent, or complete headache records as required per protocol. * Is pregnant, actively trying to become p…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01813591