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Study to Evaluate SAGE-324 in Participants With Essential Tremor

Primary Purpose

Essential Tremor

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SAGE-324
SAGE-324 Matched Placebo
Sponsored by
Sage Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Tremor focused on measuring Essential Tremor, SAGE-324

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. Willing to discontinue medications taken for the treatment of ET 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.

Exclusion Criteria:

  1. Presence of known causes of physiological tremor.
  2. Recent exposure (14 days prior to Day 1) to tremorgenic drugs 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.
  5. Historical or clinical evidence of tremor with psychogenic origin.

Sites / Locations

  • Sage Investigational SiteRecruiting
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

SAGE-324 Matched Placebo

SAGE-324 15 mg

SAGE-324 30 mg

SAGE-324 60 mg

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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 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

Change From Baseline in TETRAS Activities of Daily Living (ADL) Composite Score in the Monotherapy Cohort
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.

Full Information

First Posted
December 15, 2021
Last Updated
September 28, 2023
Sponsor
Sage Therapeutics
Collaborators
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT05173012
Brief Title
Study to Evaluate SAGE-324 in Participants With Essential Tremor
Official Title
A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose-Response Study of SAGE-324 for the Treatment of Essential Tremor
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 24, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sage Therapeutics
Collaborators
Biogen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Tremor
Keywords
Essential Tremor, SAGE-324

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SAGE-324 Matched Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
SAGE-324 15 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
SAGE-324 30 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
SAGE-324 60 mg
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
SAGE-324
Intervention Description
SAGE-324 oral tablets.
Intervention Type
Drug
Intervention Name(s)
SAGE-324 Matched Placebo
Intervention Description
SAGE-324 matched placebo oral tablets.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Baseline up to Day 91
Secondary Outcome Measure Information:
Title
Change From Baseline in TETRAS Activities of Daily Living (ADL) Composite Score in the Monotherapy Cohort
Description
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.
Time Frame
Baseline up to Day 91

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carrie Vaudreuil, MD
Phone
+1-857-259-4766
Email
carrie.vaudreuil@sagerx.com
Facility Information:
Facility Name
Sage Investigational Site
City
Hoover
State/Province
Alabama
ZIP/Postal Code
35244
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33067
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Kendall
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Naples
State/Province
Florida
ZIP/Postal Code
34105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32792
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78746
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Katy
State/Province
Texas
ZIP/Postal Code
77450
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
McLean
State/Province
Virginia
ZIP/Postal Code
22101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com
Facility Name
Sage Investigational Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
clinicaltrialsinquiry@sagerx.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.

Learn more about this trial

Study to Evaluate SAGE-324 in Participants With Essential Tremor

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