Summary:
A clinical research study for adults with essential tremor (ET).
The purpose of the KINETIC 2 TRIAL is to evaluate the safety and effectiveness of three different doses of an investigational drug in reducing tremors in individuals diagnosed with essential tremor (ET).
The total length of the KINETIC 2 TRIAL is approximately 19 weeks (or 132 days). This includes a 28-day screening period to make sure the research study is a good match for you, a 90-day treatment period in which you will receive one of three doses of the investigational drug or a placebo, and a 14-day follow-up period to check on your health after you stop taking your assigned study treatment.
Individuals will be evaluated to determine their eligibility to participate in this study. Each volunteer who participates will receive the investigational drug or the placebo, as well as study-related medical exams and study-related laboratory tests, all at no cost.
Eligible participants must:
- Be 18 to 80 years old
- Have a formal diagnosis of essential tremor for at least three years consisting of upper limb action tremor impacting both sides of the body
- Be willing to discontinue medications taken for the treatment of essential tremor, except propranolol, within 14 days prior to the study
- Use an acceptable method of contraception during study participation
- Be willing and able to comply with the study instructions
Other protocol-defined inclusion and exclusion criteria apply.
.