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

Danish Headache Center72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Enrollment

Conditions

Migraine Migraine Without Aura Migraine With Aura

Interventions

ErenumabDRUG

Subcutaneous injection of 140 mg erenumab.

PlaceboDRUG

Subcutaneous injection of saline placebo.

Calcitonin gene-related peptideDRUG

Intravenous infusion of 1.5ug/min calcitonin gene-related peptide over 20 minutes.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Danish Headache Center

Glostrup Municipality, Denmark

RECRUITING

Outcomes

Primary Outcomes

Migraine-like attack

The incidence of migraine-like attack after administration of calcitonin-gene related peptide or cilostazol in patients with migraine pretreated with erenumab compared to patients with migraine pretreated with placebo. A migraine-like attack is defined attack fulfilling either (i) or (ii): (i) Headache fulfilling criteria C and D for migraine without aura according to the International Headache Society criteria: C. Headache has at least two of the following characteristics: unilateral location; pulsating quality; moderate or severe pain intensity (moderate to severe pain intensity is considered ≥4 on verbal rating scale); aggravation by cough (in-hospital phase) or causing avoidance of routine physical activity (out-hospital phase); D. During headache at least one of the following: nausea and/or vomiting; photophobia and phonophobia; and (ii) Headache described as mimicking the patient's usual migraine attack and treated with acute migraine medication (rescue medication).

Time frame: Before (-5 min) and after administration of (+12 hours) of experimental trigger

Secondary Outcomes

Headache intensity

Change in headache intensity after administration of calcitonin-gene related peptide or cilostazol in patients with migraine pretreated with erenumab compared to patients with migraine pretreated with placebo. Headache intensity scores are measured by a numerical rating scale (NRS). It is a verbally declared scale from 0 to 10, where 0 is no pain; 10 is the worst pain imaginable.

Time frame: Before (-5 min) and after administration of (+12 hours) of experimental trigger

Hemodynamics (superficial temporal artery)

Change in diameter (mm) of superficial temporal artery after administration of calcitonin-gene related peptide or cilostazol in patients with migraine pretreated with erenumab compared to patients with migraine pretreated with placebo.

Time frame: Before (-5 min) and after administration of (+90 minutes) of experimental trigger

Hemodynamics (radial artery)

Central Contacts

Thien P Do, MD

CONTACT

004541414117 tdoo0001@regionh.dk

Data from ClinicalTrials.gov

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