A Study of T2000 in Essential Tremor - Full Text View

Sponsored by:	Taro Pharmaceuticals USA
Information provided by:	Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier:	NCT00321087

Purpose

This study will evaluate the safety and efficacy of T2000 when used to treat patients with moderate to severe essential tremor over a 20 week 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. T2000 was well tolerated for periods up to 20 days 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 20 weeks. Patient's tremor and neurological examination will be monitored throughout the study. The response to T2000 will be determined by comparing the severity of tremor while patients are receiving T2000 compared to the tremor observed without active medication.

Condition	Intervention	Phase
Essential Tremor	Drug: T2000	Phase II

Genetics Home Reference related topics: essential tremor familial paroxysmal nonkinesigenic dyskinesia

MedlinePlus related topics: Movement Disorders Tremor

Drug Information available for: Diphenhydramine Diphenhydramine citrate Diphenhydramine hydrochloride Promethazine Promethazine hydrochloride Proline

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel 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: A Randomized, Double-Blind, Placebo-Controlled, Sequential Dose Escalation Study

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. Patients receiving active treatment will be compared to placebo at 2 months of treatment. [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
Response at various dosages will be compared to baseline for all patients. [ Time Frame: Up to 6 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 6 months ] [ Designated as safety issue: Yes ]

Enrollment:	10
Study Start Date:	August 2006
Study Completion Date:	December 2007
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental T2000 dose escalation	Drug: T2000 Dose escalation from 600 to 1000 mg
2: Experimental Placebo followed by T2000 dose escalation	Drug: T2000 Placebo followed by T2000 dose escalation from 600 to 1000 mg
3: Experimental Placebo followed by T2000 dose escalation	Drug: T2000 Placebo followed by dose escalation from 600 to 1000

Eligibility

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

Criteria

Inclusion Criteria:

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00321087

Locations

Canada, Ontario
Movement Disorder Clinic: University Health Network; Toronto Western Hospital
Toronto, Ontario, Canada, M5R 2N5
Parkinson's Disease and Movement Disorders Clinic - The Ottawa Hospital: Civic Campus
Ottawa, Ontario, Canada, K1Y 4E9
London Health Sciences Center
London, Ontario, Canada, N6A 5A5

Sponsors and Collaborators

Taro Pharmaceuticals USA

Investigators

Principal Investigator:

Anthony Lang, MD FRCPC

University Health Network - Toronto Western Hospital

More Information

Responsible Party:	Taro Pharmaceuticals USA ( Medical Director )
Study ID Numbers:	T2000-0533
Study First Received:	May 1, 2006
Last Updated:	April 3, 2008
ClinicalTrials.gov Identifier:	NCT00321087
Health Authority:	Canada: Health Canada

Keywords provided by Taro Pharmaceuticals USA:

Movement Disorder

Study placed in the following topic categories:

Signs and Symptoms
Essential Tremor
Promethazine
Movement Disorders
Benign essential tremor syndrome

Central Nervous System Diseases
Neurologic Manifestations
Dyskinesias
Tremor
Diphenhydramine

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009