Induction of Migraine Aura With Sildenafil | NCT02795351

Studies
Induction of Migraine Aura With Sildenafil

NCT02795351

Sponsor

Herlev Hospital

Status

Completed

Last Update Posted

Nov 16, 2021Actual

Enrollment

16Actual

Phase

Early Phase 1

Conditions

Migraine With Aura

Interventions

Sildenafil
Placebo

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015Actual

Primary Completion Date

Feb 2021Actual

Completion Date

Aug 2021Actual

First Submitted Date

Apr 9, 2016

First Submission Date that Met QC Criteria

Jun 6, 2016

First Posted Date

Jun 10, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 13, 2021

Last Update Posted Date

Nov 16, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active	Experimental	Sildenafil 100 mg single dose	Drug: Sildenafil
Placebo	Placebo Comparator	Placebo capsule	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sildenafil	Drug	Single oral administration of active or placebo one week apart	Active

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Aura and migraine like headache	Induction of aura reported by an aura diary for 14 hours post medication	14 hours

Secondary Outcomes

Measure	Description	Time Frame
Markers of endothelial function in blood		2 hours
Migraine without aura	Induction of headache resembling usual migraine attacks	14 hours

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christina Kruuse, MD, DMSc	Department of Neurology, Herlev-Gentofte Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Neurology, Herlev-Gentofte Hospital		Herlev		2730	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35332812	Derived	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.

ID	Term
D008881	Migraine Disorders
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases

ID	Term
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D013450	Sulfones
D013457