Migraine With AuraEarly Phase 1NCT02795351
Induction of Migraine Aura With Sildenafil
A Early Phase 1 study testing Sildenafil in people with Migraine With Aura, run by Herlev Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Migraine With Aura
- What is being tested?
- Sildenafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2015to Aug 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Migraine with aura
- Minimum of 2 attacks/year
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Selective PDE5 Inhibitor, Sildenafil, on Aura and Migraine Headache Induction.
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.
- Conditions
- Migraine With Aura
- Being tested
- Sildenafil, Placebo
- Medical subject headings
- Migraine with Aura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SildenafilDrug
Single oral administration of active or placebo one week apart
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Sildenafil 100 mg single dose Receives: Drug: Sildenafil |
| Placebo | Placebo comparator | Placebo capsule Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aura and migraine like headache
Induction of aura reported by an aura diary for 14 hours post medication
Measured: 14 hours
Secondary outcomes (2)
Markers of endothelial function in blood
Measured: 2 hours
Migraine without aura
Induction of headache resembling usual migraine attacks
Measured: 14 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study startJun 2015
- Primary completionFeb 2021
- Study completionAug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Migraine With AuraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Kruuse, Herlev Hospital
- Investigators
- Christina Kruuse, MD, DMSc, Principal investigator, Department of Neurology, Herlev-Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02795351
- Sponsor's protocol ID
- H-15008491
- Status last verified
- Nov 2021
- First submitted
- 9 Apr 2016
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 35332812
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Selective PDE5 Inhibitor, Sildenafil, on Aura and Migraine Headache Induction.
- ClinicalTrials.gov ID
- NCT02795351
- Acronym / sponsor ID
- H-15008491
- Conditions
- Migraine With Aura
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Feb 2021 (actual)
- Study completion
- Aug 2021 (actual)
- First posted
- 10 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: SildenafilSildenafil 100 mg single dose |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsule |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Migraine with aura
- Minimum of 2 attacks/year
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SildenafilSingle oral administration of active or placebo one week apart | Drug | Active |
| Placebo | Drug | Placebo |
Primary outcome
Aura and migraine like headache
Time frame: 14 hours
Induction of aura reported by an aura diary for 14 hours post medication
2 secondary outcomes
Markers of endothelial function in blood
Time frame: 2 hours
Migraine without aura
Time frame: 14 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
- Derived from this study: PubMed 35332812Butt 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Kruuse, MD, DMSc principal investigator
Department of Neurology, Herlev-Gentofte Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Sildenafil in people with Migraine With Aura, run by Herlev Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aura and migraine like headache (time frame: 14 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02795351, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2021; AzTrials last refreshed its copy on 7 Nov 2026.