A Proof of Concept Study of the Effectiveness of Carisbamate in the Treatment of Essential Tremor

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effectiveness, safety and tolerability of carisbamate treatment for the signs, symptoms, and impairment associated with Essential Tremor (ET) compared to placebo treatment. The secondary objective is to evaluate the effect of carisbamate treatment on indicators of affect and mood in patients who have ET compared to placebo treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SK Life Science; SK Life Science, Inc.

Criteria

Inclusion Criteria:

• Patients in good general health

• Definite ET based on the TRIG diagnostic criteria

• Patients must have tremor affecting both upper extremities and at least 1 upper extremity must have a postural or action/intention tremor that is rated from 2 (moderate) to 4 (severe) as defined in Part A (Tremor location/severity rating) of the TRS at the Visit 2 evaluation

• Patients must have a negative urine drug screen at screening with exceptions for legally prescribed benzodiazepines or opioid analgesics. Patients must have a negative blood alcohol test at screening and be willing to abstain from alcohol for at least 24 hours prior to each study visit.

Exclusion Criteria:

• Abnormal neurologic signs or progressive neurological disorders, such as Parkinson's Disease, brain tumor, demyelinating disease, CNS trauma, active CNS infection, stroke, or any CNS disease, other than ET, that could interfere with the evaluation of tremor

• Patients with dystonia or dystonic tremors, enhanced physiologic tremor, task specific tremor (e.g., writing tremor), or historical or clinical evidence of psychogenic or fictitious movement disorders

• Patients currently taking or recently exposed to prohibited medications unless, in the opinion of the study investigator, the patient is able to follow the washout procedure and restrictions described in the protocol prior to randomization

• Patients taking more than one tremor-reducing agent who are unable to discontinue all or all but one of these medications

• Patients who have achieved no discernable tremor reduction after treatment with at least 2 of 3 following tremor-reducing medications specifically prescribed for the treatment of ET: propranolol, primidone, or topiramate

• Prior exposure to carisbamate (RWJ-333369)

• Surgical procedures for treatment of ET such as deep brain stimulation or thalamic ablation

• Current or past (within 1 year) major psychotic disorder, such as schizophrenia or other psychotic conditions, major depressive disorder with psychotic features or other psychiatric disorders

• Exacerbation of major depression within the past 6 months

• History of suicide attempts or suicidal ideation in the past year

• History of drug or alcohol abuse within the past year

• Patients who are not able to abstain from alcohol consumption for 24 hours prior to each evaluation

• Patients with abnormal screening laboratory values or ECG (electrical heart tracing)

• Patients with a history, diagnosis or clinical signs for a significant major medical disorder that might disqualify.