Study of Intravenous Erenumab in Patients With Status Migrainosus

This is an interventional treatment trial for Status Migrainosus Read More

Inclusion Criteria:

• 18 years to 70 years.
• History of migraines (with or without aura) for ≥ 12 months and history of at least 1 episode of status migrainosus based on medical records and/or patient self-report in their lifetime.
• Currently experiencing an episode of status migrainosus (non-menstrually related) per ICHD3 criteria of ≥ 3 and < 6 days.
• Migraine frequency: ≥ 2 and < 10 migraine days per month on average across the 3 months prior to screening.
• Headache (i.e., migraine and non-migraine headache) frequency: < 15 headache days per month on average across the 3 months prior to screening.
• Agree to withhold acute treatments for 24 hours after receiving erenumab IV unless medically necessary.

Exclusion Criteria:

• Older than 50 years of age at migraine onset.
• History of cluster headache or hemiplegic migraine headache.
• Past (within 4 months) or present exposure to a CGRP monoclonal antibody or CGRP small molecule receptor antagonist for migraine treatment.
• Present exposure to lasmiditan.
• New acute treatment within 7 days.
• New preventive treatment within 4 weeks.
• > 15 days acute treatment use, opioid or barbiturate use > 4 days per month.
• Use of acute treatment within 6 hours of the infusion.
• Unable to differentiate migraine from other headaches.
• Procedures (e.g., nerve blocks) or neuromodulatory devices within 7 days.
• History of major psychiatric disorder.
• History or evidence of any unstable or clinically significant medical condition, that in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
• History of myocardial infarction, stroke, transient ischemic attack, unstable angina, coronary artery bypass surgery, or other revascularization procedures within 12 months prior to screening.
• Females who are pregnant, breastfeeding, or who are trying to become pregnant.
• Not willing to use a reliable form of contraception (for women of childbearing potential) through 16 weeks after the last dose of erenumab. Acceptable methods of birth control include not having intercourse, hormonal birth control methods, intrauterine devices, surgical contraceptive methods, or two barrier methods (each partner must use a barrier method) with spermicide. A reliable form of contraception must be started prior to or at the time of starting the run-in phase. Not being of childbearing potential is defined as any woman who:
• Is post-menopausal by history, defined as:
• At least 55 years of age with cessation of menses for 12 or more months; OR
• Younger than 55 years of age but no spontaneous menses for at least 2 years; OR
• Younger than 55 years of age and spontaneous menses within the past 1 year, but currently amenorrheic (e.g., spontaneous or secondary to hysterectomy), AND with postmenopausal gonadotropin levels (luteinizing hormone and follicle-stimulating hormone levels at least 40 IU/L) or postmenopausal estradiol level (less than 5 ng/dL) or according to the definition of "postmenopausal range" for the laboratory involved; OR
• Underwent bilateral oophorectomy; OR
• Underwent hysterectomy; OR
• Underwent bilateral salpingectomy.
• Currently receiving treatment in another drug study or an investigational device study, or less than 90 days prior to screening since ending treatment on another investigational device or drug study(-ies).
• Unable to provide informed consent.
• Unlikely to be able to complete all protocol required study visits or procedures, and/or to comply with all required study procedures.