Induction of Migraine Aura With Sildenafil

Sponsor

Herlev Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02795351

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Actual 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.

Actual Study Start Date :

Jun 1, 2015

Actual Primary Completion Date :

Feb 1, 2021

Actual Study Completion Date :

Aug 1, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Aura and migraine like headache [14 hours]
Induction of aura reported by an aura diary for 14 hours post medication

Secondary Outcome Measures

Markers of endothelial function in blood [2 hours]
Migraine without aura [14 hours]
Induction of headache resembling usual migraine attacks

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Neurology, Herlev-Gentofte Hospital	Herlev		Denmark	2730

Sponsors and Collaborators

Herlev Hospital

Investigators

Principal Investigator: Christina Kruuse, MD, DMSc, Department of Neurology, Herlev-Gentofte Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Christina Kruuse, Consultant neurologist, associate professor, Herlev Hospital

ClinicalTrials.gov Identifier:

NCT02795351

Other Study ID Numbers:

H-15008491

First Posted:

Jun 10, 2016

Last Update Posted:

Nov 16, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Migraine Disorders

Migraine with Aura

Sildenafil Citrate

Study Results

No Results Posted as of Nov 16, 2021