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CompletedPhase 2

Study to Evaluate SAGE-324 in Participants With Essential Tremor

Key facts

Who runs it
Sage Therapeutics
Where
Asheville, Atlanta, Austin, Boca Raton, Boston, Boynton Beach, Bradenton, Chicago, Cincinnati, Coral Springs, Dayton, Decatur, Englewood, Farmington Hills, Fort Worth, Fountain Valley, Fullerton, Gainesville, Hollywood, Hoover, Houston, Kansas City, Katy, Kendall, Kirkland, Lansing, Las Vegas, Lexington, Los Angeles, McLean, Memphis, Miami, Naples, New York, Orlando, Pensacola, Phoenix, Port Charlotte, Round Rock, San Antonio, Scottsdale, Shreveport, Spokane, Springfield, Sun City, Tampa, Tulsa, and West Falls Church, United StatesSee the 48 sites
Trial code
Status
Completed
Phase
Phase 2
People taking part
146 people enrolled
Started
5 Jan 2022
Ended
16 May 2024
Type of study
Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • SAGE-324
  • SAGE-324 Matched Placebo
Record updated
16 May 2025

Who can take part

Age
18 years to 80 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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)
  • 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
  • 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
  • Participant has a baseline TETRAS ADL Subscale score of at least 20 at Screening
  • 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
  • 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
  • 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

Who cannot take part

  • 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
  • Direct or indirect injury or trauma to the nervous system within 3 months before the onset of tremor
  • 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
  • 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
  • Historical or clinical evidence of tremor with functional neurological syndrome origin
  • Participant currently requires propranolol treatment for a medical condition other than ET
  • Presence of known causes of enhanced physiological tremor
  • Participant has had botulinum toxin for treatment of ET within 6 months of Screening

Where in United States

  • Asheville, North CarolinaHospital not named in the registryNo longer taking part
  • Atlanta, GeorgiaHospital not named in the registryNo longer taking part
  • Austin, TexasHospital not named in the registryNo longer taking part
  • Boca Raton, FloridaHospital not named in the registryNo longer taking part
  • Boston, MassachusettsHospital not named in the registryNo longer taking part
  • Boynton Beach, FloridaHospital not named in the registryNo longer taking part
  • Bradenton, FloridaHospital not named in the registryNo longer taking part
  • Chicago, IllinoisHospital not named in the registryNo longer taking part
  • Cincinnati, OhioHospital not named in the registryNo longer taking part
  • Coral Springs, FloridaHospital not named in the registryNo longer taking part
  • Dayton, OhioHospital not named in the registryNo longer taking part
  • Decatur, GeorgiaHospital not named in the registryNo longer taking part
  • Englewood, ColoradoHospital not named in the registryNo longer taking part
  • Farmington Hills, MichiganHospital not named in the registryNo longer taking part
  • Fort Worth, TexasHospital not named in the registryNo longer taking part
  • Fountain Valley, CaliforniaHospital not named in the registryNo longer taking part
  • Fullerton, CaliforniaHospital not named in the registryNo longer taking part
  • Gainesville, FloridaHospital not named in the registryNo longer taking part
  • Hollywood, FloridaHospital not named in the registryNo longer taking part
  • Hoover, AlabamaHospital not named in the registryNo longer taking part
  • Houston, TexasHospital not named in the registryNo longer taking part
  • Kansas City, KansasHospital not named in the registryNo longer taking part
  • Katy, TexasHospital not named in the registryNo longer taking part
  • Kendall, FloridaHospital not named in the registryNo longer taking part
  • Kirkland, WashingtonHospital not named in the registryNo longer taking part
  • Lansing, MichiganHospital not named in the registryNo longer taking part
  • Las Vegas, NevadaHospital not named in the registryNo longer taking part
  • Lexington, KentuckyHospital not named in the registryNo longer taking part
  • Los Angeles, CaliforniaHospital not named in the registryNo longer taking part
  • McLean, VirginiaHospital not named in the registryNo longer taking part
  • Memphis, TennesseeHospital not named in the registryNo longer taking part
  • Miami, FloridaHospital not named in the registryNo longer taking part
  • Naples, FloridaHospital not named in the registryNo longer taking part
  • New YorkHospital not named in the registryNo longer taking part
  • Orlando, FloridaHospital not named in the registryNo longer taking part
  • Pensacola, FloridaHospital not named in the registryNo longer taking part
  • Phoenix, ArizonaHospital not named in the registryNo longer taking part
  • Port Charlotte, FloridaHospital not named in the registryNo longer taking part
  • Round Rock, TexasHospital not named in the registryNo longer taking part
  • San Antonio, TexasHospital not named in the registryNo longer taking part
  • Scottsdale, ArizonaHospital not named in the registryNo longer taking part
  • Shreveport, LouisianaHospital not named in the registryNo longer taking part
  • Spokane, WashingtonHospital not named in the registryNo longer taking part
  • Springfield, IllinoisHospital not named in the registryNo longer taking part
  • Sun City, ArizonaHospital not named in the registryNo longer taking part
  • Tampa, FloridaHospital not named in the registryNo longer taking part
  • Tulsa, OklahomaHospital not named in the registryNo longer taking part
  • West Falls Church, VirginiaHospital not named in the registryNo longer taking part

About the trial

What the trial wants to find out

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.

The 4 groups in the trial

  • SAGE-324 Matched PlaceboPlacebo, for comparison

    Participants will receive SAGE-324 matched placebo, stratified by baseline propranolol use. Monotherapy: Participants will receive SAGE-324 matched placebo, oral tablets, once daily (QD), in the evening, from Day 1 to Day 90 in a double-blind treatment period. Adjunct therapy: Participants will receive SAGE-324 matched placebo, oral tablets, QD, in the evening, from Day 1 to Day 90 along with a stable dose of up to 320 milligrams (mg) of propranolol from 3 months prior to Screening up to Day 90 in a double-blind treatment period.

  • SAGE-324 15 mgTreatment being tested

    Participants will receive SAGE-324, 15 mg, stratified by baseline propranolol use. Monotherapy: Participants will receive SAGE-324, 15 mg, oral tablets, QD, in the evening, from Day 1 to Day 90 in a double-blind treatment period. Adjunct therapy: Participants will receive SAGE-324, 15 mg, oral tablets, QD, in the evening, from Day 1 to Day 90 along with a stable dose of up to 320 mg of propranolol from 3 months prior to Screening up to Day 90 in a double-blind treatment period.

    Treatment: SAGE-324

  • SAGE-324 30 mgTreatment being tested

    Participants will receive SAGE-324, 30 mg, stratified by baseline propranolol use. Monotherapy: Participants will receive SAGE-324, 30 mg, oral tablets, QD, in the evening, from Day 1 to Day 90 in a double-blind treatment period. Adjunct therapy: Participants will receive SAGE-324, 30 mg, oral tablets, QD, in the evening, from Day 1 to Day 90 along with a stable dose of up to 320 mg of propranolol from 3 months prior to Screening up to Day 90 in a double-blind treatment period.

    Treatment: SAGE-324

  • SAGE-324 60 mgTreatment being tested

    Participants will receive SAGE-324: 15 mg, 30 mg, 45 mg, and 60 mg, stratified by baseline propranolol use. Monotherapy: Participants will receive SAGE-324, 15 mg from Day 1 to 14, followed by up-titration to 30 mg from Day 15 to 28, then to 45 mg from Day 29 to 42, and then to 60 mg from Day 43 to 90, oral tablets, QD, in the evening, from Day 1 to Day 90 in a double-blind treatment period. Adjunct therapy: Participants will receive SAGE-324, 15 mg from Day 1 to 14, followed by up-titration to 30 mg from Day 15 to 28, then to 45 mg from Day 29 to 42, and then to 60 mg from Day 43 to 90, oral tablets, QD, in the evening, from Day 1 to Day 90 along with a stable dose of up to 320 mg of propranolol from 3 months prior to Screening up to Day 90 in a double-blind treatment period.

    Treatment: SAGE-324

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose-Response Study of SAGE-324 for the Treatment of Essential Tremor
Record updated
16 May 2025