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

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Danish Headache Center
• Collaborator: Novartis Pharmaceuticals
• Treatments: Calcitonin; Calcitonin Gene-Related Peptide; Cilostazol; Erenumab; Katacalcin; Salmon calcitonin

Criteria

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