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

NCT00524056 | Completed Phase 2

• 2 other identifiers: CR014314CARISEPY2008
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Essential Tremor, Movement Disorders

Keywords

Essential Tremor; Tremor; Anti-epileptic drug (AED)

Outcome Measures

Primary Outcomes (1)

• The primary efficacy outcome is the overall normalized, restricted Tremor Rating Scale (TRS) score after carisbamate treatment compared to placebo treatment.

  At baseline, week 1, and week 3 in each treatment period

Secondary Outcomes (4)

• Overall normalized TRS score; overall normalized unrestricted TRS score, raw TRS total score, raw TRS subscale scores, normalized TRS subscale scores

  At baseline, week 1, and week 3 in each treatment period

• Profile of Mood States (POMS)

  At baseline, then at week 3 in treatment period 1 and at week 3 in treatment period 2

• Center for Epidemiological Studies Depression Scale (CES-D)

  At baseline, then at week 3 in treatment period 1 and at week 3 in treatment period 2

• Rationale for Quality of Life in Essential Tremor questionnaire (QUEST)

  At baseline, then at week 3 in treatment period 1 and at week 3 in treatment period 2

Study Arms (2)

001

EXPERIMENTAL

Carisbamate two 100 mg tablets twice per day

Drug: Carisbamate

002

PLACEBO COMPARATOR

Placebo two placebo tablets twice per day

Drug: Placebo

Interventions

Carisbamate DRUG

two 100 mg tablets twice per day

001

Placebo DRUG

two placebo tablets twice per day

002

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SK Life Science, Inc.: lead

Related Publications (1)

• Elble RJ, Biondi DM, Ascher S, Wiegand F, Hulihan J. Carisbamate in essential tremor: brief report of a proof of concept study. Mov Disord. 2010 Apr 15;25(5):634-8. doi: 10.1002/mds.22872.

  PMID: 20201005 DERIVED

MeSH Terms

Conditions

Essential Tremor; Movement Disorders; Tremor

Interventions

S-2-O-carbamoyl-1-o-chlorophenyl-ethanol

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial

  Ortho-McNeil Janssen Scientific Affairs, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2007
• First Posted: September 3, 2007
• Study Start: August 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: January 24, 2013

Record last verified: 2013-01