NCT03484871

Brief Summary

The purpose of this study is to determine whether reduced frequency of migraine attacks are associated with signal alternation and connectivity of cerebral cortex.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

May 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2016

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

April 2, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

March 20, 2020

Status Verified

March 1, 2020

Enrollment Period

2.5 years

First QC Date

September 27, 2016

Last Update Submit

March 18, 2020

Conditions

Migraine Disorders

Outcome Measures

Primary Outcomes (1)

  • functional MRI imaging changes

    temporal changes in BOLD correlations in the regions of most significant correlation with periaqueductal grey; temporal changes in BOLD correlations in the regions of most significant correlation with anterior cingulate cortex; temporal changes in default mode network

    6 month

Secondary Outcomes (4)

  • structural MRI imaging changes

    6 months

  • Functional and structural correlates of treatment response

    6 months

  • correlation of functional MRI changes with changes in clinical parameters

    6 months

  • responses to acute migraine treatment

    6 months after the first visit

Eligibility Criteria

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

Patients with migraine

You may qualify if:

  • Premenopausal Women
  • Aged 18-50
  • Drug-naïve high frequency episodic migraineurs (8-14 attacks/m)
  • Performed a baseline interictal brain MRI

You may not qualify if:

  • Medication overuse
  • Chronic pain other than migraine
  • On treatment of major depression, bipolar, schizophrenia, or BDI\>25

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Chin-Sang Chung, MD, PhD

    Department of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Professor of neurology

Study Record Dates

First Submitted

September 27, 2016

First Posted

April 2, 2018

Study Start

May 1, 2016

Primary Completion

November 1, 2018

Study Completion

April 1, 2019

Last Updated

March 20, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)