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CompletedNCT02795351Updated Nov 16, 2021

Induction of Migraine Aura With Sildenafil

An Early Phase 1 interventional study of Sildenafil and Placebo in Migraine With Aura, sponsored by Herlev Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2021-11-16.

Sponsored by Herlev Hospital · Early Phase 1, Interventional, and Basic science

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Jun 2015, registered Apr 2016).
Phase
Early Phase 1
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Migraine With Aura
03

In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

This study's enrollment of 16 is below the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

Herlev Hospital is the lead sponsor of 195 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Migraine with aura
  • Minimum of 2 attacks/year

Exclusion criteria

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
05

Study design

Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Active

    Sildenafil 100 mg single dose

    Drug: Sildenafil

  • Placebo comparator
    Placebo

    Placebo capsule

    Drug: Placebo

Interventions

  • DrugSildenafil

    Single oral administration of active or placebo one week apart

  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. Aura and migraine like headache

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

    Time frame: 14 hours

Secondary outcomes

  1. Markers of endothelial function in blood

    Time frame: 2 hours

  2. Migraine without aura

    Induction of headache resembling usual migraine attacks

    Time frame: 14 hours

07

Study locations

1 site
  • Department of Neurology, Herlev-Gentofte Hospital
    Herlev, 2730, Denmark
08

References and documents

Publications

  • Butt JH, S Eddelien H, Kruuse C. The headache and aura-inducing effects of sildenafil in patients with migraine with aura. Cephalalgia. 2022 Sep;42(10):984-992. doi: 10.1177/03331024221088998. Epub 2022 Mar 25. PubMed 35332812 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02795351
Lead sponsor
Herlev Hospital
Responsible party
Christina Kruuse (Consultant neurologist, associate professor, Herlev Hospital) — Principal investigator
First posted
Jun 10, 2016
Start date
Jun 2015
Primary completion
Feb 2021
Completion
Aug 2021
Last update
Nov 16, 2021

Study contacts

Christina Kruuse, MD, DMSc
principal investigator · Department of Neurology, Herlev-Gentofte Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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