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
  Purpose

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 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Taro Pharmaceuticals USA:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 5
Study Start Date: August 2007
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
T2000 at 600-1000 mg daily
Drug: T2000
T2000 at previous most effective, well-tolerated dose (600-1000mg daily)

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655278

Locations
Canada, Ontario
Investigator Site
London, Ontario, Canada
Investigator Site
Ottawa, Ontario, Canada
Investigator Site
Toronto, Ontario, Canada
Sponsors and Collaborators
Taro Pharmaceuticals USA
  More Information

Publications:
Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT00655278     History of Changes
Other Study ID Numbers: T2000-0639
Study First Received: April 3, 2008
Last Updated: December 19, 2013
Health Authority: Canada: Health Canada

Keywords provided by Taro Pharmaceuticals USA:
Movement Disorder

Additional relevant MeSH terms:
Essential Tremor
Tremor
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Dyskinesias
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014