Study to Evaluate SAGE-324 in Participants With Essential Tremor
Essential Tremor
About this trial
This is an interventional treatment trial for Essential Tremor focused on measuring Essential Tremor, SAGE-324
Eligibility Criteria
Inclusion Criteria:
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
- Willing to discontinue medications taken for the treatment of ET 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.
Exclusion Criteria:
- Presence of known causes of physiological tremor.
- Recent exposure (14 days prior to Day 1) to tremorgenic drugs 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.
- Historical or clinical evidence of tremor with psychogenic origin.
Sites / Locations
- Sage Investigational SiteRecruiting
- Sage Investigational SiteRecruiting
- Sage Investigational SiteRecruiting
- Sage Investigational SiteRecruiting
- Sage Investigational SiteRecruiting
- Sage Investigational SiteRecruiting
- Sage Investigational SiteRecruiting
- Sage Investigational SiteRecruiting
- Sage Investigational SiteRecruiting
- Sage Investigational SiteRecruiting
- Sage Investigational SiteRecruiting
- Sage Investigational SiteRecruiting
- Sage Investigational SiteRecruiting
- Sage Investigational SiteRecruiting
- Sage Investigational SiteRecruiting
- Sage Investigational SiteRecruiting
- Sage Investigational SiteRecruiting
- Sage Investigational SiteRecruiting
- Sage Investigational SiteRecruiting
- Sage Investigational SiteRecruiting
- Sage Investigational SiteRecruiting
- Sage Investigational SiteRecruiting
- Sage Investigational SiteRecruiting
- Sage Investigational SiteRecruiting
- Sage Investigational SiteRecruiting
- Sage Investigational SiteRecruiting
- Sage Investigational SiteRecruiting
- Sage Investigational SiteRecruiting
- Sage Investigational SiteRecruiting
- Sage Investigational SiteRecruiting
- Sage Investigational SiteRecruiting
- Sage Investigational SiteRecruiting
- Sage Investigational SiteRecruiting
- Sage Investigational SiteRecruiting
- Sage Investigational SiteRecruiting
- Sage Investigational SiteRecruiting
- Sage Investigational SiteRecruiting
- Sage Investigational SiteRecruiting
- Sage Investigational SiteRecruiting
- Sage Investigational SiteRecruiting
- Sage Investigational SiteRecruiting
- Sage Investigational SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Placebo Comparator
Experimental
Experimental
Experimental
SAGE-324 Matched Placebo
SAGE-324 15 mg
SAGE-324 30 mg
SAGE-324 60 mg
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.
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.
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.
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.