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OpenTrials
Completed

NCT Number: NCT02795351

Induction of Migraine Aura With Sildenafil

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.

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Key information

Conditions

Migraine With Aura Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Department of Neurology, Herlev-Gentofte Hospital

Herlev, 2730, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sildenafil

Drug

Single oral administration of active or placebo one week apart

Placebo

Drug

Primary outcomes

  1. Aura and migraine like headache

    Time frame: 14 hours

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

Secondary outcomes

  1. Markers of endothelial function in blood

    Time frame: 2 hours

  2. Migraine without aura

    Time frame: 14 hours

    Induction of headache resembling usual migraine attacks

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Jun 10, 2016
Registry last updated
Nov 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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