Induction of Migraine Aura With Sildenafil

Herlev Hospital

Status and phase: Completed; Early Phase 1

Conditions: Migraine With Aura

Treatments: Drug: Placebo; Drug: Sildenafil

Study type: Interventional

Funder types: Other

Identifiers

NCT02795351

H-15008491

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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16 participants in 2 patient groups, including a placebo group

Active

Experimental group

Description:

Sildenafil 100 mg single dose

Treatment:

Drug: Sildenafil

Placebo

Placebo Comparator group

Description:

Placebo capsule

Treatment:

Drug: Placebo