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Study to Evaluate SAGE-324 in Participants With Essential Tremor

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ClinicalTrials.gov Identifier: NCT05173012
Recruitment Status : Recruiting
First Posted : December 29, 2021
Last Update Posted : September 25, 2023
Sponsor:
Collaborator:
Biogen
Information provided by (Responsible Party):
Sage Therapeutics

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Essential Tremor Drug: SAGE-324 Drug: SAGE-324 Matched Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose-Response Study of SAGE-324 for the Treatment of Essential Tremor
Actual Study Start Date : January 24, 2022
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.

 Drug: SAGE-324 Matched Placebo
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.

 Drug: SAGE-324
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.

 Drug: SAGE-324
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.

 Drug: SAGE-324
SAGE-324 oral tablets.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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:

  1. Presence of known causes of enhanced physiological tremor.
  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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05173012


Contacts
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Contact: Carrie Vaudreuil, MD +1-857-259-4766 carrie.vaudreuil@sagerx.com

Locations
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United States, Alabama
Sage Investigational Site Recruiting
Hoover, Alabama, United States, 35244
Contact       clinicaltrialsinquiry@sagerx.com   
United States, California
Sage Investigational Site Recruiting
Fountain Valley, California, United States, 92708
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Fullerton, California, United States, 92835
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Florida
Sage Investigational Site Recruiting
Boca Raton, Florida, United States, 33486
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Hollywood, Florida, United States, 33024
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Miami, Florida, United States, 33136
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Miami, Florida, United States, 33175
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Miami, Florida, United States, 33176
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Naples, Florida, United States, 34105
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Tampa, Florida, United States, 33612
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Georgia
Sage Investigational Site Recruiting
Decatur, Georgia, United States, 30030
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Illinois
Sage Investigational Site Recruiting
Springfield, Illinois, United States, 62702
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Kansas
Sage Investigational Site Recruiting
Kansas City, Kansas, United States, 66103
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Kentucky
Sage Investigational Site Recruiting
Lexington, Kentucky, United States, 40509
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Massachusetts
Sage Investigational Site Recruiting
Boston, Massachusetts, United States, 02131
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Michigan
Sage Investigational Site Recruiting
Farmington Hills, Michigan, United States, 48334
Contact       clinicaltrialsinquiry@sagerx.com   
United States, New York
Sage Investigational Site Recruiting
New York, New York, United States, 10003
Contact       clinicaltrialsinquiry@sagerx.com   
United States, North Carolina
Sage Investigational Site Recruiting
Asheville, North Carolina, United States, 28806
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Ohio
Sage Investigational Site Recruiting
Cincinnati, Ohio, United States, 45219
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Dayton, Ohio, United States, 45417
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Oklahoma
Sage Investigational Site Recruiting
Tulsa, Oklahoma, United States, 74136
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Tennessee
Sage Investigational Site Recruiting
Memphis, Tennessee, United States, 38157
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Texas
Sage Investigational Site Recruiting
Austin, Texas, United States, 78746
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Fort Worth, Texas, United States, 76104
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Houston, Texas, United States, 77030
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Katy, Texas, United States, 77450
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Round Rock, Texas, United States, 78681
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Washington
Sage Investigational Site Recruiting
Spokane, Washington, United States, 99202
Contact       clinicaltrialsinquiry@sagerx.com   
Sponsors and Collaborators
Sage Therapeutics
Biogen
More Information
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Responsible Party: Sage Therapeutics
ClinicalTrials.gov Identifier: NCT05173012    
Other Study ID Numbers: 324-ETD-202
First Posted: December 29, 2021    Key Record Dates
Last Update Posted: September 25, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sage Therapeutics:
Essential Tremor
SAGE-324
Additional relevant MeSH terms:
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Tremor
Essential Tremor
Dyskinesias
Neurologic Manifestations
 Nervous System Diseases
Movement Disorders
Central Nervous System Diseases