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
1 other identifier
interventional
5
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2007
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 3, 2008
CompletedFirst Posted
Study publicly available on registry
April 9, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedDecember 23, 2013
November 1, 2013
2.3 years
April 3, 2008
December 19, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
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
Study Arms (1)
1
EXPERIMENTALT2000 at 600-1000 mg daily
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Investigator Site
London, Ontario, Canada
Investigator Site
Ottawa, Ontario, Canada
Investigator Site
Toronto, Ontario, Canada
Related Publications (1)
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.
PMID: 17265458BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2008
First Posted
April 9, 2008
Study Start
August 1, 2007
Primary Completion
November 1, 2009
Study Completion
December 1, 2009
Last Updated
December 23, 2013
Record last verified: 2013-11