A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study Evaluating the Efficacy, Safety, and Tolerability of an Investigational Drug in the Treatment of Individuals with Essential Tremor

Research Studies

Study Description:

The KINETIC Trial is a clinical research study evaluating the safety and effectiveness of an investigational drug in individuals diagnosed with essential tremor. Researchers are evaluating if the investigational drug is effective in reducing tremors.

The study comprises three periods: screening, treatment, and follow-up. Participation in the study will last approximately 71 days and will consist of seven study visits.

Study Details:

Phase: 2
Type: Double-blind, placebo-controlled
Interventions: investigational drug, placebo
Gender: Male, female
Minimum age: 18 years
Maximum age: 80 years
Enrollment goal: Approximately 60 patients
Compensation range: Speak with study site for more details
Participation length: Approximately 71 days

Study Purpose:

The overall goal of the study is to evaluate the safety and effectiveness of the investigational drug in adults with essential tremor.

Eligibility Criteria:

Key inclusion criteria:*

  • You should discuss with your prescribing physician before discontinuing any medications you are currently taking
    • Medications taken for the treatment of essential tremor that were discontinued prior to receiving the investigational medication may be resumed following Day 29 of the study

Key exclusion criteria:*

  • Participant has had an injury to the nervous system that occurred within three months before the tremors began
  • Participant has had a previous procedure for the treatment of essential tremor
  • Participant has historical or clinical evidence of tremor that occurs because of psychological or psychiatric causes, including but not limited to eating disorder or major depressive disorder
  • Participant has had exposure to another investigational drug or device within 30 days prior to the Day 1 visit
  • Female participant has a positive pregnancy test or a confirmed pregnancy at time of study
  • Participant is unwilling or unable to follow the study instructions

*There are additional eligibility requirements which the study doctor can explain to you.

To learn more or prescreen for the KINETIC Trial please visit KineticETtrial.com.

MRC-324-00143
IETF Trial Listing_324-ETD-201_06032020_V1.0
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