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T2000 in Essential Tremor - Open Label Continuation

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00655278
First received: April 3, 2008
Last updated: December 19, 2013
Last verified: November 2013

April 3, 2008
December 19, 2013
August 2007
November 2009   (final data collection date for primary outcome measure)
Effect of treatment on tremor will be measured by a tremor scale as well as by assessment of functional activity with specific tasks. [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00655278 on ClinicalTrials.gov Archive Site
Safety parameters including neurological examination, blood tests and EKG will be monitored throughout the treatment period and during withdrawal of the medication. [ Time Frame: Up to 18 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
T2000 in Essential Tremor - Open Label Continuation
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

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.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Essential Tremor
Drug: T2000
T2000 at previous most effective, well-tolerated dose (600-1000mg daily)
Experimental: 1
T2000 at 600-1000 mg daily
Intervention: Drug: T2000
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
5
December 2009
November 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00655278
T2000-0639
Yes
Taro Pharmaceuticals USA
Taro Pharmaceuticals USA
Not Provided
Not Provided
Taro Pharmaceuticals USA
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP