Management of Migraine Using Enerumab and Traditional Therapy at the Time of COVID-19

Migraine prevention is an area of a large unmet medical need, with existing prophylactic therapies often having modest efficacy and poor tolerability. Calcitonin gene-related peptide (CGRP) receptor antagonism is a novel approach to migraine preventive therapy. Erenumab is a human monoclonal antibody against CGRP receptor. The present study is a phase 3 trial intended to assess the efficacy and safety of erenumab for prevention of migraine in Egyptian adults with chronic migraine (CM).

The study consists of a screening period (up to 24 weeks, including at baseline period), a 12-week period and a 24-week period ,.

Inclusion Criteria:

• -Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All

• History of at least 5 attacks of migraine

  -≥ 15 headache days of which ≥ 8 headache days meet criteria as migraine days during the baseline period

• chronic migraineurs with failure to more than 2 preventive treatments
• chronic migraineurs without any preventive treatments
• Naive to anti CGRP monclonal antibodies

Exclusion Criteria:

• Participants are excluded from the study if any of the following criteria apply:

  • unable to understand the study requirements, the informed consent, or complete headache records as required per protocol;

• History of cluster or hemiplegic headache
• Evidence of seizure or major psychiatric disorder Cardiac or active hepatic disease
• pregnant, actively trying to become pregnant, or breast-feeding;
• episodic migraineurs,
• Other headache types
• allergy to latex;
• received nerve blocks or trigger point injections in the previous 8 weeks or plans to receive them during the study;
• prior exposure in the last 6 months to biologics or drugs specifically targeting the calcitonin gene-related peptide (CGRP) pathway;
• a psychiatric condition, that may affect the interpretation of efficacy and safety data or contraindicates the participant's participation in the study