This study will evaluate the safety and efficacy of T2000 when used to treat patients with
moderate to severe essential tremor over a 20 week period.
Essential tremor (ET) is a common form of involuntary shaking not related to Parkinson's
disease. The medications that are currently used to treat ET work in a small proportion of
patients and provide only partial improvement in symptoms. Use of these current medications
is also limited by side-effects in many patients.
T2000 is a medication currently under development for the treatment of essential tremor.
Although T2000 is a new medication, it belongs to a class of medications that has been used
for many years for the treatment of a variety of medical conditions. In previous studies,
T2000 appeared to be effective in controlling symptoms of ET and some patients with severe ET
had major improvements in tremor. T2000 was well tolerated for periods up to 20 days and the
minimal side-effects seen were those that would be expected for medications in this class.
The current study will evaluate the safety and efficacy of T2000 in patients with moderate to
severe essential tremor. Patients will receive doses of T2000 beginning at 600 mg a day,
followed by 800 mg a day and up to 1000 mg a day. The total duration of treatment will be 20
weeks. Patient's tremor and neurological examination will be monitored throughout the study.
The response to T2000 will be determined by comparing the severity of tremor while patients
are receiving T2000 compared to the tremor observed without active medication.