Induction of Migraine Aura With Sildenafil

Early Phase 1CompletedNCT02795351

Herlev Hospital16 enrolled

Overview

In a double blind placebo-controlled cross-over study the effect of Sildenafil on aura and migraine headache induction is tested in patient with migraine with aura.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Migraine With Aura

Interventions

SildenafilDRUG

Single oral administration of active or placebo one week apart

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Migraine with aura * Minimum of 2 attacks/year Exclusion Criteria: * Any other type of headache, except tension-type headache \< 4 days per month * History of cardio- or cerebrovascular diseases * Hypertension or hypotension * Any daily intake of medication, including prophylactic migraine treatment, except oral contraceptives * Pregnancy and lactation

Locations (1)

Department of Neurology, Herlev-Gentofte Hospital

Herlev, Denmark

Outcomes

Primary Outcomes

Aura and migraine like headache

Induction of aura reported by an aura diary for 14 hours post medication

Time frame: 14 hours

Secondary Outcomes

Markers of endothelial function in blood

Time frame: 2 hours

Migraine without aura

Induction of headache resembling usual migraine attacks

Time frame: 14 hours

Data from ClinicalTrials.gov

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