Essential TremorPhase 2NCT05173012
Study to Evaluate SAGE-324 in Participants With Essential Tremor
A Phase 2 study testing SAGE-324 in people with Essential Tremor, run by Sage Therapeutics at 51 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Essential Tremor
- What is being tested?
- SAGE-324
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- 51 sitesUnited States
- Study dates
- 5 Jan 2022to 16 May 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 12Show fewer
- 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 join
- Presence of known causes of enhanced physiological tremor.
- 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 had botulinum toxin for treatment of ET within 6 months of Screening.
- Historical or clinical evidence of tremor with functional neurological syndrome origin.
- Participant currently requires propranolol treatment for a medical condition other than ET.
- 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.
Trial locations and contacts
51 sites in 1 country.
51 sites in 1 country
United States51 sites
Sage Investigational Site
Asheville, North Carolina, 28806
Sage Investigational Site
Atlanta, Georgia, 30329
Sage Investigational Site
Austin, Texas, 78746
Sage Investigational Site
Boca Raton, Florida, 33486
Sage Investigational Site
Boston, Massachusetts, 02131
Sage Investigational Site
Boynton Beach, Florida, 33437
Sage Investigational Site
Bradenton, Florida, 34205
Sage Investigational Site
Chicago, Illinois, 60612
Sage Investigational Site
Cincinnati, Ohio, 45219
Sage Investigational Site
Coral Springs, Florida, 33067
Sage Investigational Site
Dayton, Ohio, 45417
Sage Investigational Site
Decatur, Georgia, 30030
Sage Investigational Site
Englewood, Colorado, 80113
Sage Investigational Site
Farmington Hills, Michigan, 48334
Sage Investigational Site
Fort Worth, Texas, 76104
Sage Investigational Site
Fountain Valley, California, 92708
Sage Investigational Site
Fullerton, California, 92835
Sage Investigational Site
Gainesville, Florida, 32608
Sage Investigational Site
Hollywood, Florida, 33024
Sage Investigational Site
Hoover, Alabama, 35244
Sage Investigational Site
Houston, Texas, 77030
Sage Investigational Site
Kansas City, Kansas, 66160
Sage Investigational Site
Katy, Texas, 77450
Sage Investigational Site
Kendall, Florida, 33176
Sage Investigational Site
Kirkland, Washington, 98034
Sage Investigational Site
Lansing, Michigan, 48824
Sage Investigational Site
Las Vegas, Nevada, 89102
Sage Investigational Site
Lexington, Kentucky, 40509
Sage Investigational Site
Los Angeles, California, 90095
Sage Investigational Site
McLean, Virginia, 22101
Sage Investigational Site
Memphis, Tennessee, 38157
Sage Investigational Site
Miami, Florida, 33136
Sage Investigational Site
Miami, Florida, 33175
Sage Investigational Site
Miami, Florida, 33176
Sage Investigational Site
Naples, Florida, 34105
Sage Investigational Site
New York, New York, 10003
Sage Investigational Site
New York, New York, 10032
Sage Investigational Site
Orlando, Florida, 32803
Sage Investigational Site
Pensacola, Florida, 32503
Sage Investigational Site
Phoenix, Arizona, 85012
Sage Investigational Site
Port Charlotte, Florida, 33980
Sage Investigational Site
Round Rock, Texas, 78681
Sage Investigational Site
San Antonio, Texas, 78229
Sage Investigational Site
Scottsdale, Arizona, 85258
Sage Investigational Site
Shreveport, Louisiana, 71105
Sage Investigational Site
Spokane, Washington, 99202
Sage Investigational Site
Springfield, Illinois, 62702
Sage Investigational Site
Sun City, Arizona, 85351
Sage Investigational Site
Tampa, Florida, 33612
Sage Investigational Site
Tulsa, Oklahoma, 74136
Sage Investigational Site
West Falls Church, Virginia, 22042
About this study
Official title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose-Response Study of SAGE-324 for the Treatment of Essential Tremor
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.
- Conditions
- Essential Tremor
- Being tested
- SAGE-324, SAGE-324 Matched Placebo
- Keywords
- Essential Tremor, SAGE-324
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAGE-324Drug
SAGE-324 oral tablets.
SAGE-324 Matched PlaceboDrug
SAGE-324 matched placebo oral tablets.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: SAGE-324 Matched Placebo |
| 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. Receives: Drug: SAGE-324 |
| 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. Receives: Drug: SAGE-324 |
| 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. Receives: Drug: SAGE-324 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in The Essential Tremor Rating Assessment Scale (TETRAS) Performance Subscale Item 4 (Upper Limb) Total Score on Day 91 in the Monotherapy Cohort
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.
Measured: Baseline, Day 91
Secondary outcomes (1)
Change From Baseline in TETRAS Activities of Daily Living (ADL) Composite Score in the Monotherapy Cohort
TETRAS ADL Subscale (items 1-12) assesses how ET affects typical ADL (speech, eating, drinking, dressing, personal hygiene, writing, occupational impairment, social impact, activities affected by UL tremor). TETRAS ADL composite score comprises Items 1-11 of ADL Subscale (Item 1: speech impairment; Item 10: occupational impairment; remaining 9 items: impairment in activities affected by UL tremor) and Item 6 of Performance Subscale (spiral drawing). Each of individual item is rated on a scale from 0 (normal activity) to 4 (severe abnormality); responses of 0 \& 1 in TETRAS ADL Subscale Items 1 to 11 were collapsed such that scale is 0 (normal/slightly abnormal), 1 (mildly abnormal), 2 (moderately abnormal), and 3 (severely abnormal). Performance Subscale Item 6 responses were collapsed with responses having 0.5 point increments grouped with next higher integer response. ADL composite score range is 0 to 39. Higher score=greater abnormality, negative change=improvement.
Measured: Baseline, Day 91
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start5 Jan 2022
- Primary completion2 May 2024
- Study completion16 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sage Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biogen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05173012
- Sponsor's protocol ID
- 324-ETD-202
- Status last verified
- May 2025
- First submitted
- 15 Dec 2021
- Last updated
- 16 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose-Response Study of SAGE-324 for the Treatment of Essential Tremor
- ClinicalTrials.gov ID
- NCT05173012
- Acronym / sponsor ID
- 324-ETD-202
- Conditions
- Essential Tremor
- Keywords
- Essential Tremor, SAGE-324
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Sage TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Biogen
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 2 May 2024 (actual)
- Study completion
- 16 May 2024 (actual)
- First posted
- 29 Dec 2021 (actual)
- Results
- Posted 16 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SAGE-324 Matched Placebo | Placebo comparator | Drug: SAGE-324 Matched PlaceboParticipants 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 | Drug: SAGE-324Participants 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 | Drug: SAGE-324Participants 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 | Drug: SAGE-324Participants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Diagnosis of ET, as defined by all of the following criteria:
- 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:
- 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.
Key exclusion criteria (8 listed)
- Presence of known causes of enhanced physiological tremor.
- 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 had botulinum toxin for treatment of ET within 6 months of Screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAGE-324SAGE-324 oral tablets. | Drug | SAGE-324 15 mg, SAGE-324 30 mg, SAGE-324 60 mg |
| SAGE-324 Matched PlaceboSAGE-324 matched placebo oral tablets. | Drug | SAGE-324 Matched Placebo |
Primary outcome
Change From Baseline in The Essential Tremor Rating Assessment Scale (TETRAS) Performance Subscale Item 4 (Upper Limb) Total Score on Day 91 in the Monotherapy Cohort
Time frame: Baseline, Day 91
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.
1 secondary outcome
Change From Baseline in TETRAS Activities of Daily Living (ADL) Composite Score in the Monotherapy Cohort
Time frame: Baseline, Day 91
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
51 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SAGE-324 in people with Essential Tremor, run by Sage Therapeutics at 51 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in The Essential Tremor Rating Assessment Scale (TETRAS) Performance Subscale Item 4 (Upper Limb) Total Score on Day 91 in the Monotherapy Cohort (time frame: Baseline, Day 91). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.