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

Primary Purpose

Essential Tremor, Movement Disorders

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Carisbamate

Placebo

About this trial

This is an interventional treatment trial for Essential Tremor, Movement Disorders focused on measuring Essential Tremor, Tremor, Anti-epileptic drug (AED)

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

001

002

Arm Description

Carisbamate two 100 mg tablets twice per day

Placebo two placebo tablets twice per day

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Profile of Mood States (POMS)

Center for Epidemiological Studies Depression Scale (CES-D)

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

Full Information

NCT ID

NCT00524056

First Posted

August 31, 2007

Last Updated

January 15, 2013

Sponsor

SK Life Science, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00524056

Brief Title

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

Official Title

A Randomized, Double Blind, Placebo-Controlled, Crossover, Proof of Concept Study to Evaluate the Effectiveness and Safety of Carisbamate in the Treatment of Essential Tremor

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

August 2007 (undefined)

Primary Completion Date

March 2008 (Actual)

Study Completion Date

March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SK Life Science, Inc.

4. Oversight

5. Study Description

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.

Detailed Description

The hypothesis of the study is that carisbamate will be effective in the treatment of Essential Tremor compared to placebo as measured by the Fahn-Tolosa-Marin Tremor Rating Scale (TRS). This randomized (study medication assigned by chance) study has 3 Phases: Screening/Washout, Double Blind Treatment (the physician and patient do not know the name of the study medication), and Exit. The Double Blind Treatment Phase has 2 Treatment Periods. Since this is a cross-over study, all subjects who complete the full Double Blind Treatment Phase will have the opportunity to take carisbamate. Carisbamate is administered as 100 mg oral tablets. During Treatment Period 1, patients will take 2 tablets of their assigned study medication (either carisbamate or placebo) two times a day for 21 days. Patients will return for clinical evaluations approximately 1 week after starting the study medication and at the end of Treatment Period 1. Patients will then reduce their dose of study medication to 1 tablet twice a day for 3 days prior to stopping all study medication for at least 11 days. Before entering Treatment Period 2, patients will return for a clinical evaluation. During Treatment Period 2, patients will take 2 tablets of their assigned study medication two times a day for 21 days. Patients will return for clinical evaluations approximately 1 week after starting the second study medication and at the end of Treatment Period 2. Patients will then reduce their study medication to 1 tablet twice a day for 3 days before stopping all study medication. Patients will return for a clinical evaluation approximately 1 week after stopping all study medication and will be contacted by telephone approximately 30 days after the last dose of study medication. Safety will be assessed during each study visit by monitoring adverse events, clinical laboratory testing, physical and neurological examinations and electrocardiograms. Patients will take 2 carisbamate 100mg tablets 2 times a day (400 mg/day) for 21 days during one Treatment Period and 2 matching placebo tablets 2 times a day for 21 days during the other Treatment Period. Patients will reduce the dose of study medication for 3 days at the end of each Treatment Period. There will be times during the study when no study medication is taken.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Essential Tremor, Movement Disorders

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Arm Title

001

Arm Type

Experimental

Arm Description

Carisbamate two 100 mg tablets twice per day

Arm Title

002

Arm Type

Placebo Comparator

Arm Description

Placebo two placebo tablets twice per day

Intervention Type

Drug

Intervention Name(s)

Carisbamate

Intervention Description

two 100 mg tablets twice per day

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

two placebo tablets twice per day

Primary Outcome Measure Information:

Title

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

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Time Frame

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

Title

Profile of Mood States (POMS)

Time Frame

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

Title

Center for Epidemiological Studies Depression Scale (CES-D)

Time Frame

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

Title

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial

Organizational Affiliation

Ortho-McNeil Janssen Scientific Affairs, LLC

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

20201005

Citation

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.

Results Reference

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

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