NCT02795351

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Jun 2015

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 10, 2016

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

November 16, 2021

Status Verified

November 1, 2021

Enrollment Period

5.7 years

First QC Date

April 9, 2016

Last Update Submit

November 13, 2021

Conditions

Migraine With Aura

Outcome Measures

Primary Outcomes (1)

  • Aura and migraine like headache

    Induction of aura reported by an aura diary for 14 hours post medication

    14 hours

Secondary Outcomes (2)

  • Markers of endothelial function in blood

    2 hours

  • Migraine without aura

    14 hours

Study Arms (2)

Active

EXPERIMENTAL

Sildenafil 100 mg single dose

Drug: Sildenafil

Placebo

PLACEBO COMPARATOR

Placebo capsule

Drug: Placebo

Interventions

SildenafilDRUG

Single oral administration of active or placebo one week apart

Active
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Migraine with aura
  • Minimum of 2 attacks/year

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, Herlev-Gentofte Hospital

Herlev, 2730, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 35332812DERIVED

MeSH Terms

Conditions

Migraine with Aura

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Migraine DisordersHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Christina Kruuse, MD, DMSc

    Department of Neurology, Herlev-Gentofte Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant neurologist, associate professor

Study Record Dates

First Submitted

April 9, 2016

First Posted

June 10, 2016

Study Start

June 1, 2015

Primary Completion

February 1, 2021

Study Completion

August 1, 2021

Last Updated

November 16, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)