A Proof of Concept Study of the Effectiveness of Carisbamate in the Treatment of Essential Tremor (NCT00524056) | Clinical Trial Compass
CompletedPhase 2
A Proof of Concept Study of the Effectiveness of Carisbamate in the Treatment of Essential Tremor
62 participantsStarted 2007-08
Plain-language 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.
Who can participate
Age range18 Years ā 85 Years
SexALL
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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 butā¦
What they're measuring
1
The primary efficacy outcome is the overall normalized, restricted Tremor Rating Scale (TRS) score after carisbamate treatment compared to placebo treatment.
Timeframe: At baseline, week 1, and week 3 in each treatment period