Migraine DisordersPhase 4NCT02424318
Topiramate and Cerebrovascular Response in Migraineurs
A Phase 4 study testing Topiramate in people with Migraine Disorders, run by SMG-SNU Boramae Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- Topiramate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to Dec 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Migraine Disorders
- Being tested
- Topiramate
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopiramateDrug
topiramate 25mg twice 1 week -> topiramate 50mg twice 7 weeks
| Study group | Role | What they receive |
|---|---|---|
| Topiramate | Experimental | topiramate 25mg twice for 1 week -> topiramate 50mg twice for 7 weeks Receives: Drug: Topiramate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measurements: Same as outcome 1.
Measured: between baseline and after 2-month treatment of topiramate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2015 (estimated)
- Study startDec 2008
- Primary completionDec 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- SMG-SNU Boramae Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyunwoo Nam, SMG-SNU Boramae Medical Center
- Investigators
- Hyunwoo Nam, MD, PhD, Principal investigator, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02424318
- Sponsor's protocol ID
- 06-2008-71
- Status last verified
- Apr 2015
- First submitted
- 15 Apr 2015
- Last updated
- 23 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Topiramate on Cerebrovascular Response to Photic Stimulation in Migraineurs
- ClinicalTrials.gov ID
- NCT02424318
- Acronym / sponsor ID
- 06-2008-71
- Conditions
- Migraine Disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- SMG-SNU Boramae Medical CenterUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 23 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Topiramate | Experimental | Drug: Topiramatetopiramate 25mg twice for 1 week -> topiramate 50mg twice for 7 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topiramatetopiramate 25mg twice 1 week -> topiramate 50mg twice 7 weeks | Drug | Topiramate |
Primary outcome
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.
1 secondary outcome
Comparison of the mean flow velocities in the middle and posterior cerebral artery
Time frame: between baseline and after 2-month treatment of topiramate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2015.
Related trials for Migraine Disorders
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyunwoo Nam, MD, PhD principal investigator
SMG-SNU Boramae Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Topiramate in people with Migraine Disorders, run by SMG-SNU Boramae Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the Cerebrovascular reactivity (time frame: between baseline and after 2-month treatment of topiramate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2015.