Essential Tremor, Movement DisordersPhase 2NCT00524056
A Proof of Concept Study of the Effectiveness of Carisbamate in the Treatment of Essential Tremor
A Phase 2 study testing Carisbamate in people with Essential Tremor, Movement Disorders, run by SK Life Science, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Essential Tremor, Movement Disorders
- What is being tested?
- Carisbamate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- Aug 2007to Mar 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 14Show fewer
- 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.
About this study
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
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.
Read the 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.
- Conditions
- Essential Tremor, Movement Disorders
- Being tested
- Carisbamate, Placebo
- Keywords
- Essential Tremor, Tremor, Anti-epileptic drug (AED)
- Medical subject headings
- Essential Tremor, Movement Disorders, Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarisbamateDrug
two 100 mg tablets twice per day
PlaceboDrug
two placebo tablets twice per day
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | Carisbamate two 100 mg tablets twice per day Receives: Drug: Carisbamate |
| 002 | Placebo comparator | Placebo two placebo tablets twice per day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy outcome is the overall normalized, restricted Tremor Rating Scale (TRS) score after carisbamate treatment compared to placebo treatment.
Measured: 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
Measured: At baseline, week 1, and week 3 in each treatment period
Profile of Mood States (POMS)
Measured: 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)
Measured: 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)
Measured: At baseline, then at week 3 in treatment period 1 and at week 3 in treatment period 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2007 (estimated)
- Study startAug 2007
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Essential Tremor, Movement DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- SK Life Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial, Study director, Ortho-McNeil Janssen Scientific Affairs, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00524056
- Sponsor's protocol ID
- CR014314
- Other IDs
- CARISEPY2008
- Status last verified
- Jan 2013
- First submitted
- 31 Aug 2007
- Last updated
- 24 Jan 2013
- Results posted
- No
Publications
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.
PubMed 20201005
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00524056
- Acronym / sponsor ID
- CR014314
- Conditions
- Essential Tremor, Movement Disorders
- Keywords
- Essential Tremor, Tremor, Anti-epileptic drug (AED)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- SK Life Science, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 3 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: CarisbamateCarisbamate two 100 mg tablets twice per day |
| 002 | Placebo comparator | Drug: PlaceboPlacebo two placebo tablets twice per day |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carisbamatetwo 100 mg tablets twice per day | Drug | 001 |
| Placebotwo placebo tablets twice per day | Drug | 002 |
Primary outcome
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
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2013.
- Derived from this study: PubMed 20201005Elble 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.
Related trials for Essential Tremor, Movement Disorders
RecruitingObservational study
The Encora X1™ in a Real World Observational Study
Essential Tremor
Recruiting
Deep Brain Stimulation Surgery for Movement Disorders
Parkinson's Disease, Essential Tremor
RecruitingObservational study
Analysis of Cutaneous Phosphorylated Alpha-Synuclein to Identify Patients at Risk of Progressing From Essential Tremor to Parkinson's Disease
Essential Tremor, Movement Disorders, Essential Tremor
Recruiting
Effects of Microelectrode-based Brain Stimulation in Humans
Essential Tremor, Parkinsons Disease (PD)
Active, not recruitingObservational study
Identifying Markers of Disease Subtypes and Disease Progression in the Syndrome of Essential Tremor
Essential Tremor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial study director
Ortho-McNeil Janssen Scientific Affairs, LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carisbamate in people with Essential Tremor, Movement Disorders, run by SK Life Science, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00524056, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2013.