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

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.

• 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,
• Surgically sterile (hysterectomy or tubal ligation or otherwise incapable of pregnancy); or,
• Sterilization of male partner; or,
• Intrauterine device with published data showing lowest expected failure rate is less than 1% per year; or,
• 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,
• 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 pregnant, or breast-feeding.
• Has a significant systemic disease that is equally painful or more painful than migraine.
• Has a progressive neurological disorder such as MS.
• Has a history of chronic disease of the immune system other than MS or a known immunodeficiency syndrome such as HIV.
• Has sensitivity to proteins of porcine origin.
• Has a known or 'new' diagnosis of diabetes mellitus (if screening blood glucose is suspicious for diabetes [> or equal to 126 mg/dL or > or equal to 7 mmol/L if fasting;> or equal to 200 mg/dL or 11.1 mmol/L if random testing] a patient should be further evaluated for diabetes mellitus), or a known or 'new' diagnosis of hypothyroidism not adequately controlled with medication.
• Has previously taken Acthar for any reason.
• Has any contraindications listed on the Acthar PI.
• Has a history of cluster headache, chronic tension type headache, or headache due to medication over use according to IHS guidelines, in the 3 months prior to study enrollment or during the baseline phase.
• Has received any other investigative drug 30 days prior to enrollment in this study.
• Who in the opinion of the Principal Investigator has a condition for which they should not be enrolled in the study.