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

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

NCT04452929•Danish Headache Center

View on ClinicalTrials.gov

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

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

Locations (1)

Danish Headache Center

Glostrup Municipality, Denmark

Key Dates

Start Date

July 22, 2020

Primary Completion Date

February 1, 2022

Completion Date

July 1, 2022

Last Updated

October 8, 2020

Enrollment

ESTIMATED participants

Conditions

MigraineMigraine Without AuraMigraine With Aura

Interventions

Erenumab

DRUG

Placebo

DRUG

Calcitonin gene-related peptide

DRUG

Cilostazol

DRUG

Contacts

Thien P Do, MD

CONTACT

004541414117 tdoo0001@regionh.dk

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 8, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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