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Trial record 1 of 1 for:    324-ETD-201
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A Study to Evaluate the Efficacy, Safety, and Tolerability of SAGE-324 in Participants With Essential Tremor

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ClinicalTrials.gov Identifier: NCT04305275
Recruitment Status : Recruiting
First Posted : March 12, 2020
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
Sage Therapeutics

Brief Summary:
This is a phase 2, double-blind, placebo-controlled study to evaluate the safety and efficacy of SAGE-324 compared to placebo on upper limb tremor reduction in individuals with essential tremor (ET).

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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, Placebo-controlled, Randomized Study Evaluating the Efficacy, Safety, and Tolerability of Sage-324 in the Treatment of Individuals With Essential Tremor
Actual Study Start Date : June 15, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tremor

Arm Intervention/treatment
Experimental: SAGE-324 60 mg
Participants will receive SAGE-324 60 mg dose (tablets) orally in the morning for 28 days.
Drug: SAGE-324
SAGE-324 oral tablet

Placebo Comparator: SAGE-324 Matched Placebo
Participants will receive SAGE-324 matched placebo, oral tablets for 28 days.
Drug: SAGE-324 Placebo
SAGE-324 matched placebo oral tablet




Primary Outcome Measures :
  1. Change From Baseline Compared to Placebo in The Essential Tremor Rating Assessment (TETRAS) Performance Subscale Part 4 Upper Limb Tremor Score on Day 29 [ Time Frame: Baseline, Day 29 ]
    TETRAS is a validated, comprehensive clinical assessment of essential tremor. For the performance subscale part 4 upper limb (UL) tremor score, all 3 maneuvers in the UL assessments of part 4 (subscale 4a, 4b, and 4c) will be completed for both arms, first for the left arm and then for the right. The part 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 Part 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 Compared to Placebo in TETRAS Performance Subscale Part 4 Upper Limb Tremor Score at all Other Timepoints [ Time Frame: Baseline, Day 1, 8, 15, 22 and on Day 42 (or Early Termination Visit [ETV] / End of Study [EOS]) ]
    For the performance subscale part 4 upper limb (UL) tremor score, all 3 maneuvers in the UL assessments of part 4 (subscale 4a, 4b, and 4c) will be completed for both arms, first for the left arm and then for the right. The part 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 Part 4 score for each upper limb ranges from 0 to 12 and for both upper limbs from 0 to 24.

  2. Change From Baseline Compared to Placebo in Kinesia ONE Accelerometer Scores [ Time Frame: Baseline, Day 1, 8, 15, 22, 29 and on Day 42 (or ETV / EOS) ]
    Kinesia ONE is a wireless motion sensor worn distally on the index finger, which utilizes 3 orthogonal accelerometers and 3 orthogonal gyroscopes to monitor three-dimensional motion. Via the Kinesia ONE software application, measures of three-dimensional motion are converted to scores ranging from 0 to 4. Higher scores indicate greater tremor severity. Motion in each arm will be captured separately.

  3. Change From Baseline Compared to Placebo in TETRAS Scale Activities of Daily Living (ADL) Score [ Time Frame: Baseline, Day 1, 8, 15, 22, 29 and on Day 42 (or ETV / EOS) ]
    The ADL subscale will assess how ET impacts typical activities of daily living (speech, eating, drinking, dressing, personal hygiene, writing, occupational impairment, social impact and activities affected by upper limb (UL) tremor). It consists of 12 items, each rated from 0 (normal activity) to 4 (severe abnormality) with overall ADL score range of 0 to 48.

  4. Change From Baseline Compared to Placebo in TETRAS Total Performance Score [ Time Frame: Baseline, Day 1, 8, 15, 22, 29 and on Day 42 (or ETV / EOS) ]
    The total performance score is based on overall rating of tremor amplitude in the voice, limbs, head, face, trunk, while performing pre-specified tasks, and functional task capabilities (handwriting, spiral drawing, and holding a pen over a dot). Each of these items is rated from 0 (no tremor) to 4 (severe tremor) with an overall performance score of 0 to 64.

  5. Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to Day 42 ]
    A TEAE is defined as an AE with onset after the start of investigational product (IP), or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study.



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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:

  • Participant has a diagnosis of ET, defined as isolated tremor syndrome consisting of bilateral upper limb action tremor for at least 3 years prior to screening, with or without tremor in other locations and 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 step-wise deterioration of tremor.
  • Participant scores at least 1.5 for each of the six items that comprise the combined total upper limb TETRAS (total performance subscale part 4) with the total score for the dominant upper limb (the sum of the three items for either the right or left upper limb, whichever is dominant) being at least 5.5, at both Screening and predose on Day 1.
  • Participant is willing to discontinue medications taken for the treatment of ET within 14 days or 5 half-lives prior to receiving IP. Medications taken for the treatment of ET that were discontinued prior to receiving IP may be resumed following Day 29.
  • Participant has no clinically significant findings, as determined by the investigator, on Screening and pre-dose Day 1 physical examination including mental state examination (MSE) and neurologic examination, 12-lead electrocardiogram (ECG), or screening clinical laboratory tests.

Exclusion Criteria:

  • Participant has a presence of known causes of enhanced physiological tremor.
  • Participant has had recent exposure (14 days prior to Day 1) to tremorgenic drugs.
  • Participant has had direct or indirect injury or trauma to the nervous system within 3 months before the onset of tremor.
  • Participant has had a previous procedure for the treatment of ET, deep brain stimulation, brain lesioning, or magnetic resonance (MR)-guided procedure, eg, MR-guided focused ultrasound.
  • Participant has historical or clinical evidence of tremor with psychogenic origin (including but not limited to eating disorders, major depression, etc.).
  • Participant has history of suicidal behavior within 2 years or answers "YES" to questions 3, 4, or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening or at Day 1 or is currently at risk for suicide in the opinion of the investigator.
  • Participant has used any known moderate or strong cytochrome P450 3A4 and/or inducers within 14 days or 5 half-lives (whichever is longer) prior to Day 1 or consumed grapefruit juice, grapefruit, Seville oranges, pomegranates, tangelos, or St. John's Wort or products containing these within 30 days prior to Day 1. Use of mild cytochrome inhibitors and/or inducers may be permitted.
  • Participant has concurrent or recent exposure (14 days or 5 half-lives, whichever is longer, prior to the Day 1 visit) to sedative/hypnotic drugs, stimulants, highly-caffeinated beverages or dietary supplements containing high doses of caffeine, or recent increase above regular daily consumption of caffeine.
  • Participant currently uses or has used within 14 days or 5 half-lives (whichever is longer) prior to Day 1, any prescription or over-the-counter medication that is a substrate of the OATP1B1 transporter.

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): NCT04305275


Contacts
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Contact: Kemi Bankole, MD 617-299-8383 Kemi.Bankole@sagerx.com

Locations
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United States, Arizona
Sage Investigational Site Recruiting
Gilbert, Arizona, United States, 85297
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Arkansas
Sage Investigational Site Recruiting
Rogers, Arkansas, United States, 72758
Contact       clinicaltrialsinquiry@sagerx.com   
United States, California
Sage Investigational Site Recruiting
Fresno, California, United States, 93710
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Long Beach, California, United States, 90806
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Colorado
Sage Investigational Site Recruiting
Englewood, Colorado, United States, 80113
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
Gainesville, Florida, United States, 32608
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, 33176
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Orlando, Florida, United States, 32806
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Port Charlotte, Florida, United States, 33980
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Saint Petersburg, Florida, United States, 33713
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Tampa, Florida, United States, 33609
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Winter Park, Florida, United States, 32789
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Georgia
Sage Investigational Site Recruiting
Decatur, Georgia, United States, 30030
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Savannah, Georgia, United States, 31406
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, 66160
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, 10032
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, 45212
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, Texas
Sage Investigational Site Recruiting
Houston, Texas, United States, 77030
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Virginia
Sage Investigational Site Recruiting
Richmond, Virginia, United States, 23229
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Richmond, Virginia, United States, 23298
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Washington
Sage Investigational Site Recruiting
Spokane, Washington, United States, 99202
Contact       clinicaltrialsinquiry@sagerx.com   
United States, West Virginia
Sage Investigational Site Recruiting
Huntington, West Virginia, United States, 25701
Contact       clinicaltrialsinquiry@sagerx.com   
Sponsors and Collaborators
Sage Therapeutics
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Responsible Party: Sage Therapeutics
ClinicalTrials.gov Identifier: NCT04305275    
Other Study ID Numbers: 324-ETD-201
First Posted: March 12, 2020    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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
Product Manufactured in and Exported from the U.S.: 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