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NCT02795351 Clinical Trial

Induction of Migraine Aura With Sildenafil

Migraine With Aura Clinical Trial

Official title:
The Effect of the Selective PDE5 Inhibitor, Sildenafil, on Aura and Migraine Headache Induction.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02795351
Other study ID # H-15008491
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date June 2015
Est. completion date August 2021

Study information
Verified date November 2021
Source Herlev Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date August 2021
Est. primary completion date February 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Sildenafil
Single oral administration of active or placebo one week apart
• Placebo

Locations
Country Name City State
Denmark Department of Neurology, Herlev-Gentofte Hospital Herlev

Sponsors (1)
Lead Sponsor Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Aura and migraine like headache Induction of aura reported by an aura diary for 14 hours post medication 14 hours
Secondary Markers of endothelial function in blood 2 hours
Secondary Migraine without aura Induction of headache resembling usual migraine attacks 14 hours
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