The Effect of Anti-calcitonin Gene-related Peptide (CGRP) Receptor Antibodies on the Headache Inducing Properties of CGRP and Cilostazol in Migraine Patients

The Effect of Anti-calcitonin Gene-related Peptide (CGRP) Receptor Antibodies on the Headache Inducing Properties of CGRP and Cilostazol in Migraine Patients

A randomized, double-blind, placebo-controlled, parallel study to investigate the effect of erenumab in calcitonin-gene related peptide and cilostazol experimental models of migraine in humans. Followed by a 6-month open-label extension.

Inclusion Criteria:

• Patients with migraine with or without aura according to the International Classification of Headache Disorders with a frequency of ≥4 migraine days per month
• 50-100 kg weight
• Participants of childbearing potential must use safe contraception (birth control) or be sexually abstinent

Exclusion Criteria:

• Any other primary headache disorder according to the International Classification of Headache Disorders except for tension-type headache
• Any secondary headache disorder according to the International Classification of Headache Disorders
• Migraine attack during the preceding 48 hours on provocation day
• Headache during the preceding 24 hours on provocation day
• Treatment with monoclonal antibodies or participation in clinical trials with monoclonal antibodies during the preceding year
• Daily consumption of any other drug/medication than oral contraception (birth control)
• Consumption of any other drug/medication later than four times the plasma half-time of the drug on provocation day except for oral contraception
• Pregnant or active breastfeeding participants
• Any cardiovascular diseases including cerebrovascular disorders
• Information in patient history or during physical examination indicating psychiatric disorders or substance abuse
• Information in patient history or during physical examination that the screening physician deems relevant for participation in the study