Induction of Migraine Aura With Sildenafil

NCT ID: NCT02795351

Last Updated: 2021-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2021-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Migraine With Aura

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active

Sildenafil 100 mg single dose

Group Type EXPERIMENTAL

Sildenafil

Intervention Type DRUG

Single oral administration of active or placebo one week apart

Placebo

Placebo capsule

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Sildenafil

Single oral administration of active or placebo one week apart

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Herlev Hospital

OTHER

Sponsor Role lead

Responsible Party

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Christina Kruuse

Consultant neurologist, associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christina Kruuse, MD, DMSc

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, Herlev-Gentofte Hospital

Locations

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Department of Neurology, Herlev-Gentofte Hospital

Herlev, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 35332812 (View on PubMed)

Other Identifiers

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H-15008491

Identifier Type: -

Identifier Source: org_study_id