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

Last updated: October 6, 2020
Sponsor: Danish Headache Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Pain

Oral Facial Pain

Pain (Pediatric)

Treatment

N/A

Clinical Study ID

NCT04452929
CGRP2020
  • Ages 18-60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with migraine with or without aura according to the InternationalClassification 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) orbe sexually abstinent

Exclusion

Exclusion Criteria:

  • Any other primary headache disorder according to the International Classification ofHeadache Disorders except for tension-type headache

  • Any secondary headache disorder according to the International Classification ofHeadache 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 withmonoclonal 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 ofthe 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 psychiatricdisorders or substance abuse

  • Information in patient history or during physical examination that the screeningphysician deems relevant for participation in the study

Study Design

Total Participants: 72
Study Start date:
July 22, 2020
Estimated Completion Date:
July 31, 2022

Connect with a study center

  • Danish Headache Center

    Glostrup, 2600
    Denmark

    Active - Recruiting

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