A Phase 2 interventional study of T2000 and T2000 in Essential Tremor, sponsored by Taro Pharmaceuticals USA. Terminated at 3 sites in Canada. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-01-22.
Sponsored by Taro Pharmaceuticals USA · Phase 2, Interventional, and Treatment
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.
257 studies on the registry are indexed under Tremor; 59 are open to participants now.
This study's enrollment of 10 is below the median of 25 across 184 interventional studies indexed under Tremor.
Browse Tremor studies →Taro Pharmaceuticals USA is the lead sponsor of 71 studies on the registry; none are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 1 (5%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
T2000 dose escalation
Drug: T2000
Placebo followed by T2000 dose escalation
Drug: T2000
Placebo followed by T2000 dose escalation
Drug: T2000
Dose escalation from 600 to 1000 mg
Placebo followed by T2000 dose escalation from 600 to 1000 mg
Placebo followed by dose escalation from 600 to 1000
Effect of treatment on tremor will be measured by a tremor scale as well as by assessment of functional activity with specific tasks. Patients receiving active treatment will be compared to placebo at 2 months of treatment.
Time frame: Up to 6 months
Response at various dosages will be compared to baseline for all patients.
Time frame: Up to 6 months
Safety parameters including neurological examination, blood tests and EKG will be monitored throughout the treatment period and during withdrawal of the medication.
Time frame: Up to 6 months
This study is terminated, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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Taro Pharmaceuticals USA