SAGE-324 for the Treatment of Essential Tremor (Protocol No. 324-ETD-202)

The purpose of this study is to determine if SAGE-324 (the study drug) reduces tremor (involuntary movements) in the arm, and whether SAGE-324 might have other effects on your essential tremor (ET) symptoms.

In order to participate you must meet the following criteria:

• Are ambulatory and between 18 to 80 years of age.
• Are in good physical health and have no clinically significant findings (excluding essential tremor), as determined by a physician on physical examination, including neurologic and mental status examinations, ECGs, or clinical laboratory tests.
• Have a diagnosis of ET, as defined by all of the following criteria:
  • Isolated tremor syndrome consisting of bilateral upper limb action tremor
  • At least 3 years duration
  • With or without tremor in other locations (eg, head, voice, or lower limbs).
• Have the absence of other neurological signs, such as dystonia, ataxia, or parkinsonism, isolated focal tremors (e.g., voice, head), task- and position-specific tremors, sudden tremor onset or evidence of stepwise deterioration of tremor.

You will be excluded from the study if any of the following criteria apply to you:

• Have the presence of known causes of physiological tremor.
• Have had newly administered tremorgenic drugs (14 days or 5 half-lives [whichever is longer] prior to Day 1) or presence of alcohol withdrawal state.
• Have had direct or indirect injury or trauma to the nervous system within 3 months before the onset of tremor.
• Have had a previous procedure for the treatment of ET, deep brain stimulation, brain lesioning, or magnetic resonance (MR) guided procedure, e.g., MR-guided focused ultrasound.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.