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
  • days left to enroll
    25
  • participants needed
    72
  • sponsor
    Danish Headache Center
Updated on 26 January 2021
headache
calcitonin gene-related peptide
cilostazol
erenumab
calcitonin

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.

Details
Condition Migraine, Migraine (Pediatric), Migraine (Adult), Migraine with Aura, Common Migraine, Primary Stabbing Headache, Migraine and Cluster Headaches, Migraine (Adult), Migraine and Cluster Headaches, Migraine (Pediatric), migraines, migraine aura
Treatment Placebo, Cilostazol, Calcitonin Gene-Related Peptide, Erenumab
Clinical Study IdentifierNCT04452929
SponsorDanish Headache Center
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

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
-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
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