Back to resultsInduction of Migraine Aura With Sildenafil
Primary Purpose
Migraine With Aura
Status
Completed
Phase
Early Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Sildenafil
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Migraine With Aura
Eligibility Criteria
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
Sites / Locations
- Department of Neurology, Herlev-Gentofte Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active
Placebo
Arm Description
Sildenafil 100 mg single dose
Placebo capsule
Outcomes
Primary Outcome Measures
Aura and migraine like headache
Induction of aura reported by an aura diary for 14 hours post medication
Secondary Outcome Measures
Markers of endothelial function in blood
Migraine without aura
Induction of headache resembling usual migraine attacks
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02795351
Brief Title
Induction of Migraine Aura With Sildenafil
Official Title
The Effect of the Selective PDE5 Inhibitor, Sildenafil, on Aura and Migraine Headache Induction.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
February 2021 (Actual)
Study Completion Date
August 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herlev Hospital
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine With Aura
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Experimental
Arm Description
Sildenafil 100 mg single dose
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsule
Intervention Type
Drug
Intervention Name(s)
Sildenafil
Intervention Description
Single oral administration of active or placebo one week apart
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Aura and migraine like headache
Description
Induction of aura reported by an aura diary for 14 hours post medication
Time Frame
14 hours
Secondary Outcome Measure Information:
Title
Markers of endothelial function in blood
Time Frame
2 hours
Title
Migraine without aura
Description
Induction of headache resembling usual migraine attacks
Time Frame
14 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Kruuse, MD, DMSc
Organizational Affiliation
Department of Neurology, Herlev-Gentofte Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurology, Herlev-Gentofte Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35332812
Citation
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.
Results Reference
derived
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Induction of Migraine Aura With Sildenafil
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