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Principal Investigator left the study site on December 28, 2012.
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The purpose of this study is to determine if Zonisamide is effective in reducing tremors in patients with Essential Tremor.
The subjects will remain on their usual medication and a baseline assessment using the Fahn Tolosa Marin tremor rating scale will be performed and will be video taped.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zonisamide | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zonisamide | Drug | 100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tremor Severity | PI has left the institution and we are unable to accurately assess the data from the remaining records. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David M Swope, MD | Loma Linda University | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Zonisamide | Zonisamide: 100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
•<=18 years Male/Female Hx essential tremor
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| ID | Title | Description |
|---|---|---|
| BG000 | Zonisamide | Zonisamide: 100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tremor Severity | PI has left the institution and we are unable to accurately assess the data from the remaining records. | Posted | 4 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zonisamide | Zonisamide: 100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks. |
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PI has left the institution and we are unable to accurately assess the data from the remaining records.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Swope | Loma Linda University | 909-558-4908 | Thamilton@llu.edu |
| ID | Term |
|---|---|
| D020329 | Essential Tremor |
| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000078305 | Zonisamide |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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| Years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 0 |
| 9 |
| 0 |
| 9 |
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| Sulfur Compounds |
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |