NCT01388699

Brief Summary

Recently, there is evidence that endothelial activation and dysfunction are associated with migraine, especially in female migraineurs with aura. Our objectives were to determine whether novel endothelial function markers are altered in female migraineurs with aura compared to age-matched controls.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2010

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

October 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 7, 2011

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

July 18, 2018

Status Verified

July 1, 2018

Enrollment Period

10 months

First QC Date

July 5, 2011

Last Update Submit

July 16, 2018

Conditions

Keywords

Migraine with aura

Outcome Measures

Primary Outcomes (1)

  • Endothelial Microparticles

    Levels of endothelial microparticlel in the peripheral blood using flow cytometry

    baseline

Secondary Outcomes (2)

  • Levels of circulating Endothelial Progenitor Cells

    baseline

  • Digital pulse volume change

    baseline

Study Arms (2)

migraine group

female migraineurs with aura

control group

healthy women without headache syndrome

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

female migraineurs from outpatient clinic

You may qualify if:

  • migraine with aura
  • age \< 50
  • female gender

You may not qualify if:

  • severe infectious disease
  • cardiovascular disease (stroke, coronary heart disease, myocardial infarction)
  • vasculitis
  • peripheral artery disease
  • diabetes mellitus
  • pregnancy
  • drug abuse
  • medication: statin, anticoagulation, aspirin, clopidogrel
  • intake of triptans \<24h

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Stroke Research Berlin

Berlin, 10117, Germany

Location

Related Publications (3)

  • Liman TG, Neeb L, Rosinski J, Wellwood I, Reuter U, Doehner W, Heuschmann PU, Endres M. Peripheral endothelial function and arterial stiffness in women with migraine with aura: a case-control study. Cephalalgia. 2012 Apr;32(6):459-66. doi: 10.1177/0333102412444014. Epub 2012 Apr 20.

    PMID: 22523187BACKGROUND
  • Liman TG, Bachelier-Walenta K, Neeb L, Rosinski J, Reuter U, Bohm M, Endres M. Circulating endothelial microparticles in female migraineurs with aura. Cephalalgia. 2015 Feb;35(2):88-94. doi: 10.1177/0333102414529671. Epub 2014 Apr 8.

    PMID: 24715500BACKGROUND
  • Liman TG, Neeb L, Rosinski J, Reuter U, Endres M. Stromal Cell-Derived Factor-1 Alpha Is Decreased in Women With Migraine With Aura. Headache. 2016 Sep;56(8):1274-9. doi: 10.1111/head.12839. Epub 2016 May 30.

    PMID: 27238143BACKGROUND

MeSH Terms

Conditions

Migraine with Aura

Condition Hierarchy (Ancestors)

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

Study Officials

  • Thomas Liman, MD

    Center for Stroke Research Berlin, Charité Campus Mitte

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD MSC

Study Record Dates

First Submitted

July 5, 2011

First Posted

July 7, 2011

Study Start

October 1, 2010

Primary Completion

August 1, 2011

Study Completion

December 1, 2011

Last Updated

July 18, 2018

Record last verified: 2018-07

Locations