Essential Tremor Clinical Trial
Official title:
Phase II Efficacy and Safety of Taro Pharmaceuticals' Pro-Drug T2000 (1,3-dimethoxymethyl-5,5-diphenyl-barbituric Acid) in Patients With Essential Tremor: An Open-Label Dose Continuation Study
Verified date | November 2013 |
Source | Taro Pharmaceuticals USA |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 5 |
Est. completion date | December 2009 |
Est. primary completion date | November 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Investigator Site | London | Ontario |
Canada | Investigator Site | Ottawa | Ontario |
Canada | Investigator Site | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Taro Pharmaceuticals USA |
Canada,
Melmed C, Moros D, Rutman H. Treatment of essential tremor with the barbiturate T2000 (1,3-dimethoxymethyl-5,5-diphenyl-barbituric acid). Mov Disord. 2007 Apr 15;22(5):723-7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effect of treatment on tremor will be measured by a tremor scale as well as by assessment of functional activity with specific tasks. | Up to 18 months | No | |
Secondary | Safety parameters including neurological examination, blood tests and EKG will be monitored throughout the treatment period and during withdrawal of the medication. | Up to 18 months | Yes |
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