A Proof of Concept Study of the Effectiveness of Carisbamate in the Treatment of Essential Tremor
Condition: Essential Tremor, Movement Disorders
MeSH terms: Tremor; Movement Disorders; Essential Tremor
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Carisbamate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): two 100 mg tablets twice per day; two placebo tablets twice per day
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Essential Tremor; Tremor; Anti-epileptic drug (AED)