- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05173012
Study to Evaluate SAGE-324 in Participants With Essential Tremor
A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose-Response Study of SAGE-324 for the Treatment of Essential Tremor
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Carrie Vaudreuil, MD
- Phone Number: +1-857-259-4766
- Email: carrie.vaudreuil@sagerx.com
Study Locations
-
-
Alabama
-
Hoover, Alabama, United States, 35244
- Sage Investigational Site
-
-
Arizona
-
Scottsdale, Arizona, United States, 85258
- Sage Investigational Site
-
-
California
-
Fountain Valley, California, United States, 92708
- Sage Investigational Site
-
Fullerton, California, United States, 92835
- Sage Investigational Site
-
Los Angeles, California, United States, 90095
- Sage Investigational Site
-
-
Colorado
-
Englewood, Colorado, United States, 80113
- Sage Investigational Site
-
-
Florida
-
Boca Raton, Florida, United States, 33486
- Sage Investigational Site
-
Bradenton, Florida, United States, 34205
- Sage Investigational Site
-
Coral Springs, Florida, United States, 33067
- Sage Investigational Site
-
Gainesville, Florida, United States, 32608
- Sage Investigational Site
-
Hollywood, Florida, United States, 33024
- Sage Investigational Site
-
Kendall, Florida, United States, 33176
- Sage Investigational Site
-
Miami, Florida, United States, 33136
- Sage Investigational Site
-
Miami, Florida, United States, 33176
- Sage Investigational Site
-
Miami, Florida, United States, 33175
- Sage Investigational Site
-
Naples, Florida, United States, 34105
- Sage Investigational Site
-
Pensacola, Florida, United States, 32503
- Sage Investigational Site
-
Tampa, Florida, United States, 33612
- Sage Investigational Site
-
Winter Park, Florida, United States, 32792
- Sage Investigational Site
-
-
Georgia
-
Atlanta, Georgia, United States, 30329
- Sage Investigational Site
-
Decatur, Georgia, United States, 30030
- Sage Investigational Site
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- Sage Investigational Site
-
Springfield, Illinois, United States, 62702
- Sage Investigational Site
-
-
Kansas
-
Kansas City, Kansas, United States, 66160
- Sage Investigational Site
-
-
Kentucky
-
Lexington, Kentucky, United States, 40509
- Sage Investigational Site
-
-
Louisiana
-
Shreveport, Louisiana, United States, 71105
- Sage Investigational Site
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02131
- Sage Investigational Site
-
-
Michigan
-
Farmington Hills, Michigan, United States, 48334
- Sage Investigational Site
-
-
New York
-
New York, New York, United States, 10032
- Sage Investigational Site
-
New York, New York, United States, 10003
- Sage Investigational Site
-
-
North Carolina
-
Asheville, North Carolina, United States, 28806
- Sage Investigational Site
-
-
Ohio
-
Dayton, Ohio, United States, 45417
- Sage Investigational Site
-
-
Oklahoma
-
Tulsa, Oklahoma, United States, 74136
- Sage Investigational Site
-
-
Tennessee
-
Memphis, Tennessee, United States, 38157
- Sage Investigational Site
-
-
Texas
-
Austin, Texas, United States, 78746
- Sage Investigational Site
-
Fort Worth, Texas, United States, 76104
- Sage Investigational Site
-
Houston, Texas, United States, 77030
- Sage Investigational Site
-
Katy, Texas, United States, 77450
- Sage Investigational Site
-
Round Rock, Texas, United States, 78681
- Sage Investigational Site
-
San Antonio, Texas, United States, 78229
- Sage Investigational Site
-
-
Virginia
-
Fairfax, Virginia, United States, 22042
- Sage Investigational Site
-
McLean, Virginia, United States, 22101
- Sage Investigational Site
-
-
Washington
-
Kirkland, Washington, United States, 98034
- Sage Investigational Site
-
Spokane, Washington, United States, 99202
- Sage Investigational Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 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 oral tablets.
|
Experimental: 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 oral tablets.
|
Experimental: 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 oral tablets.
|
Experimental: 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 oral tablets.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 up to Day 91
|
TETRAS is a validated, comprehensive clinical assessment of essential tremor.
For the performance subscale item 4 upper limb (UL) tremor score, all 3 maneuvers in the UL assessments of item 4 (subscale 4a, 4b, and 4c) will be completed for both arms, first for the left arm and then for the right.
The item 4 subscale ordinally rates postural (limbs extended forward and wing-beating [elbows flexed]), and kinetic (finger-nose-finger maneuver) tremor on a 0 to 4 severity scale in 0.5-point increments.
TETRAS Item 4 score for each upper limb ranges from 0 to 12 and for both upper limbs from 0 to 24.
|
Baseline up to Day 91
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in TETRAS Activities of Daily Living (ADL) Composite Score in the Monotherapy Cohort
Time Frame: Baseline up to Day 91
|
TETRAS ADL subscale assesses how ET affects typical ADL (i.e., speech, eating, drinking, dressing, personal hygiene, writing, occupational impairment, social impact, and activities affected by upper limb tremor).
It consists of 12 items, each item rated on a scale from 0 (normal activity) to 4 (severe abnormality).
The performance subscale assesses the overall rating of tremor in the voice, limbs, head, face, trunk, while performing prespecified tasks, and also measures functional task capabilities, i.e., handwriting, spirography, and holding a pen over a dot.
It consists of 16 items, each item rated on a scale from 0 (no tremor) to 4 (severe tremor).
The ADL composite score comprises items 1 to 11 of the ADL subscale and item 6 of the performance subscale, each item rated on a scale from 0 (normal/slightly abnormal) to 3 (severely abnormal) and the overall score range is 0 to 36.
A negative change from baseline will indicate improvement.
|
Baseline up to Day 91
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 324-ETD-202
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Essential Tremor
-
Emory UniversityCompletedEssential Tremor | Essential Vocal Tremor | Essential Voice Tremor | Voice Tremor | Vocal TremorUnited States
-
Syracuse UniversityNational Institute on Deafness and Other Communication Disorders (NIDCD)CompletedEssential Voice Tremor | Voice Tremor | Vocal Tremor | Essential Tremor of VoiceUnited States
-
ES Therapeutics Australia Pty LtdRecruitingTremor, EssentialCanada
-
InSightecActive, not recruitingNeurologic Manifestations | Tremor | Tremor, EssentialKorea, Republic of, Canada
-
University of MinnesotaRecruitingEssential Tremor | Upper Extremity Essential TremorUnited States
-
Xiangya Hospital of Central South UniversityEnrolling by invitation
-
SK Life Science, Inc.CompletedEssential Tremor, Movement Disorders
-
Merz Pharmaceuticals GmbHCompletedEssential Tremor of the Upper LimbUnited States, Canada, Poland
-
AbbVieRecruitingUpper Limb Essential Tremor (UL ET)United States, Canada
-
Merz Pharmaceuticals GmbHCompleted
Clinical Trials on SAGE-324 Matched Placebo
-
Sage TherapeuticsCompletedEssential TremorUnited States
-
Sage TherapeuticsRecruitingEssential TremorUnited States
-
ADARx Pharmaceuticals, Inc.RecruitingHereditary AngioedemaAustralia
-
Sage TherapeuticsActive, not recruitingMild Cognitive Impairment | Alzheimer's Disease | Mild DementiaUnited States, Puerto Rico
-
Sage TherapeuticsCompletedParkinson Disease | Cognitive DysfunctionUnited States
-
China Medical University HospitalCompletedStroke | Hemorrhagic Transformation Due to Acute Stroke
-
BiogenCompleted
-
GlaxoSmithKlineCompletedMuscular DystrophiesGermany, Belgium, Turkey, Netherlands, Spain, Israel, Australia, France, United Kingdom
-
Ore Pharmaceuticals, Inc.UnknownMild to Moderate Ulcerative ColitisCanada, India