Induction of Migraine Aura With Sildenafil

November 13, 2021 updated by: Christina Kruuse, Herlev Hospital

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Herlev, Denmark, 2730
        • Department of Neurology, Herlev-Gentofte Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo capsule
Drug: Placebo
Experimental: Active
Sildenafil 100 mg single dose
Drug: Sildenafil
Single oral administration of active or placebo one week apart

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aura and migraine like headache
Time Frame: 14 hours
Induction of aura reported by an aura diary for 14 hours post medication
14 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Markers of endothelial function in blood
Time Frame: 2 hours
2 hours
Migraine without aura
Time Frame: 14 hours
Induction of headache resembling usual migraine attacks
14 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herlev Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

February 1, 2021

Study Completion (Actual)

August 1, 2021

Study Registration Dates

First Submitted

April 9, 2016

First Submitted That Met QC Criteria

June 6, 2016

First Posted (Estimate)

June 10, 2016

Study Record Updates

Last Update Posted (Actual)

November 16, 2021

Last Update Submitted That Met QC Criteria

November 13, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-15008491

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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