Induction of Migraine Aura With Sildenafil

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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02795351

Enrollment

Registered

2016-06-10

Start date

2015-06-30

Completion date

2021-08-31

Last updated

2021-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine With Aura

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.

Interventions

DRUGSildenafil

Single oral administration of active or placebo one week apart

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026