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T2000 in Essential Tremor - Open Label Continuation

Primary Purpose

Essential Tremor

Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
T2000
Sponsored by
Taro Pharmaceuticals USA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Tremor focused on measuring Movement Disorder

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Investigator Site
  • Investigator Site
  • Investigator Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

T2000 at 600-1000 mg daily

Outcomes

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.

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.

Full Information

First Posted
April 3, 2008
Last Updated
December 19, 2013
Sponsor
Taro Pharmaceuticals USA
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1. Study Identification

Unique Protocol Identification Number
NCT00655278
Brief Title
T2000 in Essential Tremor - Open Label Continuation
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Terminated
Study Start Date
August 2007 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taro Pharmaceuticals USA

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Tremor
Keywords
Movement Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
T2000 at 600-1000 mg daily
Intervention Type
Drug
Intervention Name(s)
T2000
Intervention Description
T2000 at previous most effective, well-tolerated dose (600-1000mg daily)
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Investigator Site
City
London
State/Province
Ontario
Country
Canada
Facility Name
Investigator Site
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Investigator Site
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
17265458
Citation
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. doi: 10.1002/mds.21321.
Results Reference
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T2000 in Essential Tremor - Open Label Continuation

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