Topiramate and Cerebrovascular Response in Migraineurs

Phase 4

Completed

• Conditions: Migraine Disorders
• Interventions: Drug: Topiramate

• Registration Number: NCT02424318
• Lead Sponsor: SMG-SNU Boramae Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Primary Completion: 2009-12
• Study Completion: 2010-12
• Status Verified: 2015-04
• Study First Submitted: 2015-04-15
• Study First Submitted QC: 2015-04-18
• Last Update Submitted: 2015-04-18
• Study First Posted: 2015-04-23
• Last Update Posted: 2015-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Topiramate	Topiramate	topiramate 25mg twice for 1 week -\> topiramate 50mg twice for 7 weeks

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.