MigraineNCT00732108
Is Topiramate Effective in Treating Dizziness in Patient's With Migraine-Associated Dizziness
A study testing topiramate in people with Migraine and Headache, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this study is to determine whether topiramate effective in treating dizziness symptoms that are associated with migraine headaches. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- topiramate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Aug 2011
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of migraine-associated dizziness.
Who cannot join
- Previous or current use of topiramate prior to study enrollment.
- Need for continued use of the following medications for any medical reason during the study: ergots, anti-epileptics, beta-blockers, calcium channel blockers, monoamine oxidase inhibitors, high-dose magnesium, high-dose riboflavin, corticosteroids, local anesthetics, botulinum toxin, or herbal preparations.
- History of nephrolithiasis.
- Women whom are pregnant or breastfeeding.
- Patients with known sensitivity to topiramate.
- Patients with a history of glaucoma.
- Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Efficacy of Topiramate in Patients Wih Migraine-Associated Dizziness
The purpose of this study is to determine whether topiramate effective in treating dizziness symptoms that are associated with migraine headaches.
Read the detailed description
Migraine is a common disorder, often associated with dizziness symptoms. In many cases, dizziness is one of the only manifestations of migraine headaches. Various classes of drugs have been advocated as treatment for migraine-associated dizziness, though none has been shown to be superior over the others.
Topiramate is a drug approved for migraine prophylaxis. This study is designed to assess if there are significant changes in dizziness frequency and severity in patients diagnosed with migraine-associated dizziness treated with topiramate. Demonstrating benefit of topiramate with a placebo-controlled study to alleviate symptoms of dizziness would serve to clarify effective treatment options for patients with migraine-associated dizziness.
- Being tested
- topiramate, lactulose placebo pill
- Keywords
- migraine, headache, dizziness, vertigo, topiramate, Topamax
- Medical subject headings
- Migraine Disorders, Headache, Dizziness, Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topiramateDrug
Also called Topamax
50mg orally for 2 weeks, then 100mg orally for 6 weeks
lactulose placebo pillDrug
Also called placebo pill
1 placebo pill orally for 2 weeks, then 2 placebo pills orally for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| topiramate | Experimental | topiramate 50mg orally for 2 weeks, then 100mg orally for 6 weeks Receives: Drug: topiramate |
| 2 | Placebo comparator | 1 placebo pill orally for 2 weeks, then 2 placebo pills orally for 6 weeks Receives: Drug: lactulose placebo pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean 28-day monthly vertigo frequency from baseline.
Measured: 4 weeks, 8 weeks
Change in Dizziness Handicap Inventory scores from baseline.
Measured: 4 weeks, 8 weeks
Secondary outcomes (1)
Change in an individual's perception of vertigo symptoms based on a 1 to 10 scale.
Measured: 4 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2008 (estimated)
- Study startNov 2008
- Primary completionAug 2011 (estimated)
Why it stopped: No subjects enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Otolaryngology-Head and Neck Surgery Foundation
- Investigators
- Lawrence R Lustig, M.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00732108
- Sponsor's protocol ID
- H48626-32352-01
- Status last verified
- Mar 2015
- First submitted
- 7 Aug 2008
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Topiramate in Patients Wih Migraine-Associated Dizziness
- ClinicalTrials.gov ID
- NCT00732108
- Acronym / sponsor ID
- H48626-32352-01
- Keywords
- migraine, headache, dizziness, vertigo, topiramate, Topamax
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No subjects enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- American Academy of Otolaryngology-Head and Neck Surgery Foundation
- Study start
- Nov 2008
- Primary completion
- Aug 2011 (estimated)
- First posted
- 11 Aug 2008 (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 determine whether topiramate effective in treating dizziness symptoms that are associated with migraine headaches.
Detailed description
Migraine is a common disorder, often associated with dizziness symptoms. In many cases, dizziness is one of the only manifestations of migraine headaches. Various classes of drugs have been advocated as treatment for migraine-associated dizziness, though none has been shown to be superior over the others.
Topiramate is a drug approved for migraine prophylaxis. This study is designed to assess if there are significant changes in dizziness frequency and severity in patients diagnosed with migraine-associated dizziness treated with topiramate. Demonstrating benefit of topiramate with a placebo-controlled study to alleviate symptoms of dizziness would serve to clarify effective treatment options for patients with migraine-associated dizziness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| topiramate | Experimental | Drug: topiramatetopiramate 50mg orally for 2 weeks, then 100mg orally for 6 weeks |
| 2 | Placebo comparator | Drug: lactulose placebo pill1 placebo pill orally for 2 weeks, then 2 placebo pills orally for 6 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of migraine-associated dizziness.
Key exclusion criteria (7 listed)
- Previous or current use of topiramate prior to study enrollment.
- Need for continued use of the following medications for any medical reason during the study: ergots, anti-epileptics, beta-blockers, calcium channel blockers, monoamine oxidase inhibitors, high-dose magnesium, high-dose riboflavin, corticosteroids, local anesthetics, botulinum toxin, or herbal preparations.
- History of nephrolithiasis.
- Women whom are pregnant or breastfeeding.
- Patients with known sensitivity to topiramate.
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 |
|---|---|---|
| topiramateAlso: Topamax50mg orally for 2 weeks, then 100mg orally for 6 weeks | Drug | topiramate |
| lactulose placebo pillAlso: placebo pill1 placebo pill orally for 2 weeks, then 2 placebo pills orally for 6 weeks | Drug | 2 |
Primary outcome
Change in mean 28-day monthly vertigo frequency from baseline.
Time frame: 4 weeks, 8 weeks
Change in Dizziness Handicap Inventory scores from baseline.
Time frame: 4 weeks, 8 weeks
1 secondary outcome
Change in an individual's perception of vertigo symptoms based on a 1 to 10 scale.
Time frame: 4 weeks, 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
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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.
Lawrence R Lustig, M.D. principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing topiramate in people with Migraine and Headache, run by University of California, San Francisco at 1 site in United States.
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 1 inclusion and 7 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: withdrawn, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in mean 28-day monthly vertigo frequency from baseline. (time frame: 4 weeks, 8 weeks). The study lists 2 primary outcomes in all. 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 6 Mar 2015.