Induction of Migraine Aura With Sildenafil

Early Phase 1

Completed

• Conditions: Migraine With Aura
• Interventions: Drug: Sildenafil; Drug: Placebo

• Registration Number: NCT02795351
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2016-04-09
• Study First Submitted QC: 2016-06-06
• Study First Posted: 2016-06-10
• Primary Completion: 2021-02
• Study Completion: 2021-08
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-13
• Last Update Posted: 2021-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Migraine with aura
• Minimum of 2 attacks/year

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active	Sildenafil	Sildenafil 100 mg single dose
Placebo	Placebo	Placebo capsule

Primary Outcome Measures

Name	Time	Method
Aura and migraine like headache	14 hours	Induction of aura reported by an aura diary for 14 hours post medication

Secondary Outcome Measures

Name	Time	Method
Markers of endothelial function in blood	2 hours
Migraine without aura	14 hours	Induction of headache resembling usual migraine attacks

Trial Locations

Locations (1)

Department of Neurology, Herlev-Gentofte Hospital; 🇩🇰 Herlev, Denmark