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Sponsored by: |
Taro Pharmaceuticals USA |
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Information provided by: | Taro Pharmaceuticals USA |
ClinicalTrials.gov Identifier: | NCT00655278 |
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.
Condition | Intervention | Phase |
---|---|---|
Essential Tremor |
Drug: T2000 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 5 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
T2000 at 600-1000 mg daily
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Drug: T2000
T2000 at previous most effective, well-tolerated dose (600-1000mg daily)
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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. In some patients T2000 was well tolerated for periods up to 5 months 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 18 months. Patient's tremor and neurological examination will be monitored throughout the study.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients will be enrolled following completion of a dose escalation trial (such as T2000-0533)
Exclusion Criteria:
Contact: Gail Somer | gsomer@globalcp.com |
Canada, Ontario | |
Movement Disorder Clinic: University Health Network; Toronto Western Hospital | Not yet recruiting |
Toronto, Ontario, Canada, M5R 2N5 | |
Contact: Julie So 416-603-5875 jso@uhnres.utoronto.ca | |
Principal Investigator: Anthony Lang, MD FRCPC | |
Parkinson's Disease and Movement Disorders Clinic - The Ottawa Hospital: Civic Campus | Not yet recruiting |
Ottawa, Ontario, Canada, K1Y 4E9 | |
Contact: Melodie Mortensen 613-798-5555 ext 14619 mmortensen@ohri.ca | |
Principal Investigator: David Grimes, MD FRCPC | |
London Health Sciences Center | Recruiting |
London, Ontario, Canada, N6A 5A5 | |
Contact: Cheryl Horn 519-685-8500 ext 35178 Cheryl.Horn@lhsc.on.ca | |
Principal Investigator: Mandar Jog, MD FRCPC |
Principal Investigator: | Anthony Lang, MD FRCPC | University Health Network - Toronto Western Hospital |
Responsible Party: | Taro Pharmaceuticals USA ( Medical Director ) |
Study ID Numbers: | T2000-0639 |
Study First Received: | April 3, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00655278 |
Health Authority: | Canada: Health Canada |
Movement Disorder |
Signs and Symptoms Essential Tremor Promethazine Movement Disorders Benign essential tremor syndrome |
Central Nervous System Diseases Neurologic Manifestations Dyskinesias Tremor Diphenhydramine |
Nervous System Diseases |