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| ID | Type | Description | Link |
|---|---|---|---|
| 080-19000-H56501 |
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| Name | Class |
|---|---|
| Ortho-McNeil Neurologics, Inc. | INDUSTRY |
Topiramate is a medication that has been approved by the Food and Drug Administration (FDA) for the treatment of patients with seizures. The trade name for this drug is Topamax®. Topiramate has not been approved by the FDA for the treatment of cluster headache and is experimental for the purposes of this research study. If a subject participates in this study, he/she will increase his/her dose of topiramate rapidly in the first few weeks to try to stop the cluster attacks and then will continue on a maintenance dose of topiramate in order to determine if it can prevent attacks from occurring during that cluster period. We believe that this will lead not only to a faster but a more complete remission of the cluster period.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topiramate | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the average daily frequency of moderate or severe attacks between baseline period to the period of day 14 to 56. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the average daily frequency of any attacks from the baseline period through the entire treatment period. | ||
| Change in the average daily duration of any attacks from the baseline period through the entire treatment period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William B Young, MD | Thomas Jefferson University, Jefferson Headache Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jefferson Headache Center | Philadelphia | Pennsylvania | 19107 | United States |
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| ID | Term |
|---|---|
| D003027 | Cluster Headache |
| ID | Term |
|---|---|
| D051303 | Trigeminal Autonomic Cephalalgias |
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| D000077236 | Topiramate |
| ID | Term |
|---|---|
| D005632 | Fructose |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 |
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| Change in the average daily attack severity from baseline period through the entire treatment period. |
| Change in the average daily frequency of any attacks from the baseline period to each week during the treatment period. |
| Change in the average daily duration of any attacks from the baseline period to each week during the treatment period. |
| Change in the average daily attack severity from the baseline period to each week during the treatment period. |
| Time to the first week from the baseline period with a 50% reduction in average daily frequency of moderate or severe attacks. |
| Change in use of acute and rescue medications from the baseline period through the entire treatment period. |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| Carbohydrates |
| D007661 | Ketoses |