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.

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 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.