Topiramate and Cerebrovascular Response in Migraineurs

Effect of Topiramate on Cerebrovascular Response to Photic Stimulation in Migraineurs

The purpose of this study is to evaluate the effect of topiramate on cerebrovascular reactivity and mean flow velocity to photic stimulation in migraineurs.

Study Overview

• Status: Completed
• Conditions: Migraine Disorders
• Intervention / Treatment: Drug: Topiramate

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	between baseline and after 2-month treatment of topiramate

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the mean flow velocities in the middle and posterior cerebral artery	Measurements: Same as outcome 1.	between baseline and after 2-month treatment of topiramate

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: April 15, 2015
• First Submitted That Met QC Criteria: April 18, 2015
• First Posted (Estimate): April 23, 2015

Study Record Updates

• Last Update Posted (Estimate): April 23, 2015
• Last Update Submitted That Met QC Criteria: April 18, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Hypoglycemic Agents; Physiological Effects of Drugs; Anticonvulsants; Topiramate
• Other Study ID Numbers: 06-2008-71