Essential Tremor
Conditions
Keywords
ET
Brief summary
The purpose of this study is to determine if Zonisamide is effective in reducing tremors in patients with Essential Tremor.
Detailed description
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.
Interventions
DRUGZonisamide
100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks.
Sponsors
Loma Linda University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of Essential Tremor based on the Tremor Investigational Group criteria for definite or probable Essential Tremor. 2. Age: 18 years or over. 3. Willingness and ability to comply with the study requirements and give informed consent.
Exclusion criteria
1. Known history of psychiatric disorder, major depression, dementia, aplastic anemia, or Stevens-Johnson syndrome. 2. Known alcohol or substance abuse in previous 12 months. 3. Positive pregnancy test. 4. Unwillingness to use adequate contraceptive methods if of childbearing potential. 5. Known allergy to sulfonamides. 6. Laboratory abnormalities prior to onset of trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tremor Severity | 4 weeks | PI has left the institution and we are unable to accurately assess the data from the remaining records. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Zonisamide Zonisamide: 100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks. | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | Zonisamide |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age, Continuous | 66.1 Years STANDARD_DEVIATION 16.33078 |
| Region of Enrollment United States | 9 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
Tremor Severity
PI has left the institution and we are unable to accurately assess the data from the remaining records.
Time frame: 4 weeks