for people ages 18-80 (full criteria)
study started
completion around



The primary purpose of this study is to evaluate the dose-response relationship of different doses of SAGE-324 on upper extremity tremor in participants with essential tremor (ET) in the monotherapy cohort.

Official Title

A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose-Response Study of SAGE-324 for the Treatment of Essential Tremor


Essential Tremor, SAGE-324, Tremor, SAGE-324 15 mg, SAGE-324 30 mg, SAGE-324 60 mg


You can join if…

Open to people ages 18-80

  1. 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)
  2. Absence of other neurological signs, such as dystonia, ataxia, or parkinsonism, isolated focal tremors (eg, voice, head), task- and position-specific tremors, sudden tremor onset, or evidence of stepwise deterioration of tremor.
  3. Participant has the following:
    • Scores of at least 12 in the combined TETRAS Performance Subscale Item 4 (upper limb tremor) at both Screening and pre-dose on Day 1
    • Scores of at least 6 in the total TETRAS Performance Subscale Item 4 score for the dominant upper limb (the sum of the three items for either the right or left upper limb, whichever is dominant) at both Screening and pre-dose on Day 1
  4. Participant has a baseline TETRAS ADL Subscale score of at least 20 at Screening.
  5. Willing to discontinue medications taken for the treatment of ET except propranolol at least 14 days or 5 half-lives (whichever is longer) prior to receiving the investigational product (IP). Medications taken for the treatment of ET that were discontinued prior to receiving IP may be resumed following Day 97. Participants in the adjunct therapy cohort must be on a stable dose of propranolol (maximum total daily propranolol dose up to 320 mg allowed) for the treatment of ET from 3 months prior to Screening through Day 97 of the study.
  6. Participant is willing to limit use of alcohol to 2 units per day for males and 1 unit per day for females starting at least 1 week prior to Day 1 and through Day 97 of the study.
  7. Participant is willing to maintain prestudy consumption of products that contain nicotine starting at least 1 week prior to Day 1 and through Day 97 of the study.

You CAN'T join if...

  1. Presence of known causes of enhanced physiological tremor.
  2. Participant has had newly administered tremorgenic drugs (14 days or 5 half-lives [whichever is longer] prior to Day 1) or presence of alcohol withdrawal state.
  3. Direct or indirect injury or trauma to the nervous system within 3 months before the onset of tremor.
  4. Previous procedure for the treatment of ET, deep brain stimulation, brain lesioning, or magnetic resonance (MR) guided procedure, eg, MR-guided focused ultrasound. Use of Cala Trio bracelet for the treatment of ET from two weeks prior to Day 1 through Day 97 is prohibited.
  5. Participant has had botulinum toxin for treatment of ET within 6 months of Screening.
  6. Historical or clinical evidence of tremor with functional neurological syndrome origin.
  7. Participant currently requires propranolol treatment for a medical condition other than ET.
  8. Participant has history of substance abuse or dependence prior to Screening, has a positive screen for drugs of abuse at Screening or predose on Day 1. Participants with nicotine use disorder that impacts their tremor are excluded.


  • Sage Investigational Site
    Los Angeles California 90095 United States
  • Sage Investigational Site
    Fountain Valley California 92708 United States
  • Sage Investigational Site
    Fullerton California 92835 United States


in progress, not accepting new patients
Start Date
Completion Date
Sage Therapeutics
Phase 2 Essential Tremor Research Study
Study Type
Expecting 160 study participants
Last Updated