Topiramate and Cerebrovascular Response in Migraineurs

NCT02424318 | Completed Phase 4 DMC

• 1 other identifier: 06-2008-71
• Study Type: interventional
• Target: 19
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Migraine Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  between baseline and after 2-month treatment of topiramate

Study Arms (1)

Topiramate

EXPERIMENTAL

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

Drug: Topiramate

Interventions

Topiramate DRUG

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

Topiramate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• SMG-SNU Boramae Medical Center: lead

MeSH Terms

Conditions

Migraine Disorders

Interventions

Topiramate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

• Hyunwoo Nam, MD, PhD

  SMG-SNU Boramae Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: SMG-SNU Boramae Medical Center

Study Record Dates

• First Submitted: April 15, 2015
• First Posted: April 23, 2015
• Study Start: December 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2010
• Last Updated: April 23, 2015

Record last verified: 2015-04