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Induction of Migraine Aura With Sildenafil

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02795351
Recruitment Status : Recruiting
First Posted : June 10, 2016
Last Update Posted : October 23, 2018
Information provided by (Responsible Party):
Christina Kruuse, Herlev Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Migraine With Aura Drug: Sildenafil Drug: Placebo Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect of the Selective PDE5 Inhibitor, Sildenafil, on Aura and Migraine Headache Induction.
Study Start Date : June 2015
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Arm Intervention/treatment
Experimental: Active
Sildenafil 100 mg single dose
Drug: Sildenafil
Single oral administration of active or placebo one week apart

Placebo Comparator: Placebo
Placebo capsule
Drug: Placebo

Primary Outcome Measures :
  1. Aura and migraine like headache [ Time Frame: 14 hours ]
    Induction of aura reported by an aura diary for 14 hours post medication

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02795351

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Contact: Christina Kruuse, MD, DMSc +4538681233

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Department of Neurology, Herlev-Gentofte Hospital Recruiting
Herlev, Denmark, 2730
Contact: Christina Kruuse, MD, DMSc    +4538681233      
Sponsors and Collaborators
Herlev Hospital
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Principal Investigator: Christina Kruuse, MD, DMSc Department of Neurology, Herlev-Gentofte Hospital
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Responsible Party: Christina Kruuse, Consultant neurologist, associate professor, Herlev Hospital Identifier: NCT02795351    
Other Study ID Numbers: H-15008491
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Migraine Disorders
Migraine with Aura
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents