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Effect of Levcromakalim in Individuals With Migraine Pretreated With Erenumab

NCT05889442 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2023-10-24

No results posted yet for this study

Summary

An outstanding scientific question, that merits further investigation, is whether dilation of intracranial arteries is implicated in the pathogenesis of cephalic pain in migraine. Here, we hypothesize that experimentally-induced dilation of intracranial arteries using intravenous infusion of levcromakalim (a potent vasodilator) induces cephalic pain with migraine-like features in people with migraine, who prior to the infusion are administered erenumab (anti-calcitonin gene-related peptide (CGRP) receptor monoclonal antibody).

Conditions

  • Migraine Without Aura

Interventions

DRUG

Levcromakalim

Continuous intravenous infusion of 20 mL levcromakalim (0.05 mg/min (50 μg/ mL) over 20 minutes

OTHER

Placebo

Continuous intravenous infusion of 20 mL isotonic saline over 20 minutes

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Danish Headache Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-09
Primary Completion
2023-06-12
Completion
2023-06-12

Countries

  • Denmark

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05889442 on ClinicalTrials.gov