T2000 in Essential Tremor - Open Label Continuation

• Status: Terminated
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety and efficacy of T2000 when used to treat patients with moderate to severe essential tremor over an 18 month period.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taro Pharmaceuticals USA

Criteria

Inclusion Criteria:

Patients will be enrolled following completion of a dose escalation trial (such as T2000-0533)

• Confirmed essential tremor by NIH criteria

• Significant functional activity limitation due to ET

• Patients who have failed, are inadequately treated or cannot tolerate alternative treatments for ET as well as treatment naïve patients who have considered but declined alternative treatment

Exclusion Criteria:

• Patients adequately controlled without side effects on a current ET treatment

• Pregnant patients or patients who may become pregnant during the study

• Patients with other medical conditions that may cause tremor, such as Parkinson's disease or active hyperthyroidism

• Patients taking medications that might produce tremor or interfere with the evaluation of tremor such as CNS-stimulants or beta-blockers

• Patients who must take medications that alter liver metabolism as well as patients with liver disease or coagulation disorders

• Patients with seizure disorders

• Patients with a history of allergy or hypersensitivity reaction to barbiturates or other related medications, such as phenobarbital or phenytoin

• Patient with significant general medical or clinical laboratory abnormalities