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Completed

NCT Number: NCT02424318

Topiramate and Cerebrovascular Response 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.

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Key information

Conditions

Migraine Disorders Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Topiramate

Drug

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

Primary outcomes

  1. Comparison of the Cerebrovascular reactivity

    Time frame: 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 outcomes

  1. Comparison of the mean flow velocities in the middle and posterior cerebral artery

    Time frame: between baseline and after 2-month treatment of topiramate

    Measurements: Same as outcome 1.

Sponsors and collaborators

Lead sponsor

SMG-SNU Boramae Medical Center

Other

Registry information

Official study title

Effect of Topiramate on Cerebrovascular Response to Photic Stimulation in Migraineurs

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Apr 23, 2015
Registry last updated
Apr 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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