Back to resultsTopiramate and Cerebrovascular Response in Migraineurs
Primary Purpose
Migraine Disorders
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Topiramate
Sponsored by
About this trial
This is an interventional treatment trial for Migraine Disorders
Eligibility Criteria
Inclusion Criteria:
- aged 18 to 65 years
- newly-diagnosed patients with migraine without aura (International Headache Society classification)
- symptom frequency (at least 2 episodes of migraine attack/month)
Exclusion Criteria:
- prior use of preventive medication
- patients with cardiovascular risk factors (hypertension, diabetes, hyperlipidemia, smoking)
- patients who take antihypertensive agent or antidepressant
- patients who were pregnant, breast-feeding or actively smoking
- patients with neurological or cerebrovascular diseases
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Topiramate
Arm Description
topiramate 25mg twice for 1 week -> topiramate 50mg twice for 7 weeks
Outcomes
Primary Outcome Measures
Comparison of the Cerebrovascular reactivity
Transcranial Doppler sonography (TCD) was performed twice in migraineurs before and after the topiramate treatment during their interictal period of headache.
Measurements: the mean flow velocity (MFV) of the right middle cerebral artery (MCA) and the left posterior cerebral artery (PCA). After 1 minute of adaptation period to the darkness, flashlights of 10 Hz were presented using a light source of an electroencephalography machine (PS40/R-220, Grass Technologies, West Warwick, USA). Recordings were performed for 10 cycles, and each cycle consisted of 10-second stimulation-on and 10-second stimulation-off.
Calculation: Cerebrovascular reactivity (CVR) CVR = Δ V/Vb or Δ V/(VbxΔT) Where Vb is the baseline MFV, Δ V/Vb is the percentage MFV increase (amplitude), ΔT is the time from the onset of the stimulation to the peak MFV, and Δ V/(VbxΔT) is the slope of the MFV increase.
Secondary Outcome Measures
Comparison of the mean flow velocities in the middle and posterior cerebral artery
Measurements: Same as outcome 1.
Full Information
NCT ID
NCT02424318
First Posted
April 15, 2015
Last Updated
April 18, 2015
Sponsor
SMG-SNU Boramae Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02424318
Brief Title
Topiramate and Cerebrovascular Response in Migraineurs
Official Title
Effect of Topiramate on Cerebrovascular Response to Photic Stimulation in Migraineurs
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
SMG-SNU Boramae Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effect of topiramate on cerebrovascular reactivity and mean flow velocity to photic stimulation in migraineurs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Topiramate
Arm Type
Experimental
Arm Description
topiramate 25mg twice for 1 week -> topiramate 50mg twice for 7 weeks
Intervention Type
Drug
Intervention Name(s)
Topiramate
Intervention Description
topiramate 25mg twice 1 week -> topiramate 50mg twice 7 weeks
Primary Outcome Measure Information:
Title
Comparison of the Cerebrovascular reactivity
Description
Transcranial Doppler sonography (TCD) was performed twice in migraineurs before and after the topiramate treatment during their interictal period of headache.
Measurements: the mean flow velocity (MFV) of the right middle cerebral artery (MCA) and the left posterior cerebral artery (PCA). After 1 minute of adaptation period to the darkness, flashlights of 10 Hz were presented using a light source of an electroencephalography machine (PS40/R-220, Grass Technologies, West Warwick, USA). Recordings were performed for 10 cycles, and each cycle consisted of 10-second stimulation-on and 10-second stimulation-off.
Calculation: Cerebrovascular reactivity (CVR) CVR = Δ V/Vb or Δ V/(VbxΔT) Where Vb is the baseline MFV, Δ V/Vb is the percentage MFV increase (amplitude), ΔT is the time from the onset of the stimulation to the peak MFV, and Δ V/(VbxΔT) is the slope of the MFV increase.
Time Frame
between baseline and after 2-month treatment of topiramate
Secondary Outcome Measure Information:
Title
Comparison of the mean flow velocities in the middle and posterior cerebral artery
Description
Measurements: Same as outcome 1.
Time Frame
between baseline and after 2-month treatment of topiramate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
aged 18 to 65 years
newly-diagnosed patients with migraine without aura (International Headache Society classification)
symptom frequency (at least 2 episodes of migraine attack/month)
Exclusion Criteria:
prior use of preventive medication
patients with cardiovascular risk factors (hypertension, diabetes, hyperlipidemia, smoking)
patients who take antihypertensive agent or antidepressant
patients who were pregnant, breast-feeding or actively smoking
patients with neurological or cerebrovascular diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyunwoo Nam, MD, PhD
Organizational Affiliation
SMG-SNU Boramae Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Topiramate and Cerebrovascular Response in Migraineurs
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