Status:
TERMINATED
T2000 in Essential Tremor - Open Label Continuation
Lead Sponsor:
Sun Pharmaceutical Industries, Inc.
Conditions:
Essential Tremor
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00655278
Start Date
August 1 2007
End Date
December 1 2009
Last Update
December 23 2013
Active Locations (3)
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1
Investigator Site
London, Ontario, Canada
2
Investigator Site
Ottawa, Ontario, Canada
3
Investigator Site
Toronto, Ontario, Canada