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

Sponsor
SK Life Science, Inc.
Study ID
NCT00524056
Phase
PHASE2
Status
Completed

Conditions

  • Essential Tremor, Movement Disorders

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Carisbamate — DRUG
    two 100 mg tablets twice per day
  • Placebo — DRUG
    two placebo tablets twice per day

Study Details

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.

Key Dates

Start date
Aug 31, 2007
Status verified
Jan 2013
Primary completion
Mar 31, 2008
Completion
Mar 31, 2008

Study Design

Enrollment
62 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: 001
    Carisbamate two 100 mg tablets twice per day
  • Placebo Comparator: 002
    Placebo two placebo tablets twice per day

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 ]

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