Topiramate and Cerebrovascular Response in Migraineurs

Migraine Disorders Clinical Trial

Official title:

Effect of Topiramate on Cerebrovascular Response to Photic Stimulation in Migraineurs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02424318
• Other study ID #: 06-2008-71
• Status: Completed
• Phase: Phase 4
• First received: April 15, 2015
• Last updated: April 18, 2015
• Start date: December 2008
• Est. completion date: December 2010

Study information

• Verified date: April 2015
• Source: SMG-SNU Boramae Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine Disorders

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
SMG-SNU Boramae Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 = ? V/Vb or ? V/(Vbx?T) Where Vb is the baseline MFV, ? V/Vb is the percentage MFV increase (amplitude), ?T is the time from the onset of the stimulation to the peak MFV, and ? V/(Vbx?T) is the slope of the MFV increase.	between baseline and after 2-month treatment of topiramate
Secondary	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