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Topiramate and Cerebrovascular Response in Migraineurs

Sponsor
SMG-SNU Boramae Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02424318
Collaborator
(none)
19
Enrollment
1
Arm
24
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Topiramate on Cerebrovascular Response to Photic Stimulation in Migraineurs
Study Start Date :
Dec 1, 2008
Actual Primary Completion Date :
Dec 1, 2009
Actual Study Completion Date :
Dec 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: Topiramate

topiramate 25mg twice for 1 week -> topiramate 50mg twice for 7 weeks

Drug: Topiramate
topiramate 25mg twice 1 week -> topiramate 50mg twice 7 weeks

Outcome Measures

Primary Outcome Measures

  1. Comparison of the Cerebrovascular reactivity [between baseline and after 2-month treatment of topiramate]

    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

  1. Comparison of the mean flow velocities in the middle and posterior cerebral artery [between baseline and after 2-month treatment of topiramate]

    Measurements: Same as outcome 1.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • SMG-SNU Boramae Medical Center

Investigators

  • Principal Investigator: Hyunwoo Nam, MD, PhD, SMG-SNU Boramae Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hyunwoo Nam, SMG-SNU Boramae Medical Center, SMG-SNU Boramae Medical Center
ClinicalTrials.gov Identifier:
NCT02424318
Other Study ID Numbers:
  • 06-2008-71
First Posted:
Apr 23, 2015
Last Update Posted:
Apr 23, 2015
Last Verified:
Apr 1, 2015
Additional relevant MeSH terms:
Migraine Disorders
Topiramate

Study Results

No Results Posted as of Apr 23, 2015