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.