Status:
TERMINATED
A Study of T2000 in Essential Tremor
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 a 20 week period. Essential tremor (ET) is a common form of involun...
Eligibility Criteria
Inclusion
- 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 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00321087
Start Date
August 1 2006
End Date
December 1 2007
Last Update
January 22 2014
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