Not provided
Not provided
Not provided
Not provided
Not provided
No subjects enrolled
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| American Academy of Otolaryngology-Head and Neck Surgery Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine whether topiramate effective in treating dizziness symptoms that are associated with migraine headaches.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| topiramate | Experimental | topiramate 50mg orally for 2 weeks, then 100mg orally for 6 weeks |
|
| 2 | Placebo Comparator | 1 placebo pill orally for 2 weeks, then 2 placebo pills orally for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| topiramate | Drug | 50mg orally for 2 weeks, then 100mg orally for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean 28-day monthly vertigo frequency from baseline. | 4 weeks, 8 weeks | |
| Change in Dizziness Handicap Inventory scores from baseline. | 4 weeks, 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in an individual's perception of vertigo symptoms based on a 1 to 10 scale. | 4 weeks, 8 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lawrence R Lustig, M.D. | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
Not provided
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D006261 | Headache |
| D004244 | Dizziness |
| D014717 | Vertigo |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077236 | Topiramate |
| ID | Term |
|---|---|
| D005632 | Fructose |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| lactulose placebo pill | Drug | 1 placebo pill orally for 2 weeks, then 2 placebo pills orally for 6 weeks |
|
|
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012678 | Sensation Disorders |
| D015837 | Vestibular Diseases |
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| Carbohydrates |
| D007661 | Ketoses |