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SAGE-324 · 2 trials · 1 indication
TETRAS is a clinical evaluation of essential tremor. The TETRAS performance subscale upper limb tremor score is a component of TETRAS. For the TETRAS Performance Subscale Item 4 (upper limb), three maneuvers/assessments were to be completed for both arms, first for the right arm and then for the left, specifically Item 4a, limbs extended forward maneuver (postural tremor), Item 4b, wing-beating \[elbows flexed\] maneuver (postural tremor), and Item 4c finger-nose-finger maneuver (kinetic tremor). Each assessment is rated on a 0 to 4 scale of severity in 0.5-point increments, with higher scores indicating more severe tremor. The Performance Subscale Item 4 (upper limb) total score range for a given side (left or right) is 0 to 12, and for both sides combined is 0 to 24. A negative change from baseline indicates improvement. Mixed model for repeated measures (MMRM) was used for the analysis.
The Essential Tremor Rating Assessment Scale (TETRAS) is a clinical evaluation of essential tremor. The TETRAS performance subscale upper limb tremor score is a component of TETRAS. The TETRAS performance subscale upper limb tremor total score is the sum of the TETRAS individual item scores from both arms of the body. The TETRAS individual item score included TETRAS Performance Subscale items 4a, 4b, and 4c scores \[4a: limbs extended forward maneuver, 4b: wing-beating (elbows flexed) maneuver, and 4c: kinetic (finger-nose-finger) maneuver\] scores from both arms of the body. Each individual item score ranges from 0 to 4; with 0 to 12 being the score range for each arm of the body. The total upper limb score combined for both arms ranges from 0 to 24. Higher scores=more severe tremor. A negative change from baseline =improvement. Mixed model repeated measures (MMRM) was used for the analysis.
| Arm | Type | Description |
|---|---|---|
| SAGE-324 Matched Placebo | PLACEBO_COMPARATOR | 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 mg | EXPERIMENTAL | 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. |
| SAGE-324 30 mg | EXPERIMENTAL | 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. |
| SAGE-324 60 mg | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| SAGE-324 | DRUG | SAGE-324 oral tablets. |
| SAGE-324 Matched Placebo | DRUG | SAGE-324 matched placebo oral tablets. |
| SAGE-324 Placebo | DRUG | SAGE-324 matched placebo oral tablet |
Inclusion Criteria: 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 ne...
SAGE-324 is an investigational small molecule being developed by Sage Therapeutics for the treatment of essential tremor, a neurological movement disorder. It has been studied in Phase 2 clinical trials in adults with essential tremor. It is not approved for any indication and remains in clinical development.
SAGE-324 is being developed by Sage Therapeutics, Inc., which trades on the Nasdaq under the ticker SAGE. Sage Therapeutics is the sponsor of the clinical program evaluating SAGE-324 in essential tremor.
SAGE-324 is in Phase 2 development for essential tremor. Two Phase 2 trials have been completed, and no trials are currently active. SAGE-324 is investigational and has not been approved by the FDA for any indication.
SAGE-324 has been evaluated in two completed Phase 2 trials in essential tremor: NCT05173012, which enrolled 146 participants, and NCT04305275, which enrolled 69 participants. Both were randomized, double-blind, placebo-controlled studies conducted in the United States in adults aged 18 and older.
The SAGE-324 clinical program in essential tremor enrolled a total of 215 participants across two completed Phase 2 trials. NCT05173012 enrolled 146 participants and NCT04305275 enrolled 69 participants. Both studies were randomized, double-blind, and placebo-controlled.