Study to Evaluate SAGE-324 in Participants With Essential Tremor
NCT ID: NCT05173012
Last Updated: 2025-05-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
146 participants
INTERVENTIONAL
2022-01-05
2024-05-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SAGE-324 Matched Placebo
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 Matched Placebo
SAGE-324 matched placebo oral tablets.
SAGE-324 15 mg
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
SAGE-324 oral tablets.
SAGE-324 30 mg
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
SAGE-324 oral tablets.
SAGE-324 60 mg
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.
SAGE-324
SAGE-324 oral tablets.
Interventions
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SAGE-324
SAGE-324 oral tablets.
SAGE-324 Matched Placebo
SAGE-324 matched placebo oral tablets.
Eligibility Criteria
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Inclusion 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.
Exclusion Criteria
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.
18 Years
80 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Sage Therapeutics
INDUSTRY
Responsible Party
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Locations
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Sage Investigational Site
Hoover, Alabama, United States
Sage Investigational Site
Phoenix, Arizona, United States
Sage Investigational Site
Scottsdale, Arizona, United States
Sage Investigational Site
Sun City, Arizona, United States
Sage Investigational Site
Fountain Valley, California, United States
Sage Investigational Site
Fullerton, California, United States
Sage Investigational Site
Los Angeles, California, United States
Sage Investigational Site
Englewood, Colorado, United States
Sage Investigational Site
Boca Raton, Florida, United States
Sage Investigational Site
Boynton Beach, Florida, United States
Sage Investigational Site
Bradenton, Florida, United States
Sage Investigational Site
Coral Springs, Florida, United States
Sage Investigational Site
Gainesville, Florida, United States
Sage Investigational Site
Hollywood, Florida, United States
Sage Investigational Site
Kendall, Florida, United States
Sage Investigational Site
Miami, Florida, United States
Sage Investigational Site
Miami, Florida, United States
Sage Investigational Site
Miami, Florida, United States
Sage Investigational Site
Naples, Florida, United States
Sage Investigational Site
Orlando, Florida, United States
Sage Investigational Site
Pensacola, Florida, United States
Sage Investigational Site
Port Charlotte, Florida, United States
Sage Investigational Site
Tampa, Florida, United States
Sage Investigational Site
Atlanta, Georgia, United States
Sage Investigational Site
Decatur, Georgia, United States
Sage Investigational Site
Chicago, Illinois, United States
Sage Investigational Site
Springfield, Illinois, United States
Sage Investigational Site
Kansas City, Kansas, United States
Sage Investigational Site
Lexington, Kentucky, United States
Sage Investigational Site
Shreveport, Louisiana, United States
Sage Investigational Site
Boston, Massachusetts, United States
Sage Investigational Site
Farmington Hills, Michigan, United States
Sage Investigational Site
Lansing, Michigan, United States
Sage Investigational Site
Las Vegas, Nevada, United States
Sage Investigational Site
New York, New York, United States
Sage Investigational Site
New York, New York, United States
Sage Investigational Site
Asheville, North Carolina, United States
Sage Investigational Site
Cincinnati, Ohio, United States
Sage Investigational Site
Dayton, Ohio, United States
Sage Investigational Site
Tulsa, Oklahoma, United States
Sage Investigational Site
Memphis, Tennessee, United States
Sage Investigational Site
Austin, Texas, United States
Sage Investigational Site
Fort Worth, Texas, United States
Sage Investigational Site
Houston, Texas, United States
Sage Investigational Site
Katy, Texas, United States
Sage Investigational Site
Round Rock, Texas, United States
Sage Investigational Site
San Antonio, Texas, United States
Sage Investigational Site
McLean, Virginia, United States
Sage Investigational Site
West Falls Church, Virginia, United States
Sage Investigational Site
Kirkland, Washington, United States
Sage Investigational Site
Spokane, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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324-ETD-202
Identifier Type: -
Identifier Source: org_study_id
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