A Study to Evaluate the Long-term Safety and Tolerability of SAGE-324 in Participants With Essential Tremor

NCT05366751 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 324-ETD-303
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 38

Brief Summary

The primary purpose of this study is to evaluate the long-term safety and tolerability of SAGE-324 in participants with essential tremor (ET).

Conditions

Essential Tremor

Keywords

SAGE-324

Outcome Measures

Primary Outcomes (1)

• Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs)

  An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. A TEAE is defined as an AE with onset after the first dose of IP, or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study.

  Up to 814 days

Secondary Outcomes (6)

• Number of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements: Heart Rate, Systolic Blood Pressure (SBP), and Diastolic Blood Pressure (DBP)

  Up to 814 days

• Number of Participants With PCS Electrocardiogram (ECG) Findings for QT Corrected According to Fridericia's Formula [QTcF])

  Up to 814 days

• Number of Participants With PCS Laboratory Parameters

  Up to 814 days

• Change From Baseline in Epworth Sleepiness Scale (ESS) Score

  Baseline, Days 8, 15, 22, 29, 36, 43, 50, 57, 70, 84, 112, 140, 168, 274, 365, 456, 548, 639, 730, 765, End of Treatment [EOT] (anytime, up to Day 793), End of Study [EOS] (anytime, up to Day 814)

• Number of Participants With Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) Responses

  Baseline up to Day 814

Study Arms (1)

SAGE-324 60 mg

EXPERIMENTAL

Participants will receive SAGE-324 15 milligrams (mg) from Day 1 to Day 14, followed by up-titration to 30 mg from Day 15 to Day 28, then to 45 mg from Day 29 to Day 42, and then 60 mg starting on Day 43, orally, once daily.

Drug: SAGE-324

Interventions

SAGE-324 DRUG

SAGE-324 oral tablets

SAGE-324 60 mg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is in good physical health and has no clinically significant findings (excluding ET) that may impact their ability to participate in the study, as determined by the investigator, on physical examination, 12-lead electrocardiogram (ECG), or clinical laboratory tests.
• Participant has a clinician-confirmed diagnosis of ET in compliance with all the following criteria:
• Duration of at least 3 years
• Absence of other neurological signs, such as dystonia, ataxia, parkinsonism, task- and position-specific tremors, sudden tremor onset, or evidence of stepwise deterioration of tremor
• Absence of historical or clinical evidence of tremor with psychogenic origin (including, but not limited to, eating disorders and major depression)
• Participant has completed the planned end of treatment (EOT) visit and was not early terminated during the planned Treatment Period in another SAGE-324 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 the End of Study (EOS) Visit.
• Participant will limit alcohol use to at least 2 hours before self-administration of investigational product (IP) in the evening.
• Participant will not use alcohol starting 24 hours prior to scheduled in-clinic study visits until all assessments have been completed.
• Participant is willing to maintain prestudy consumption of products that contain nicotine starting at least 1 week prior to Day 1 and through EOS Visit.

You may not qualify if:

• Participant has presence of alcohol withdrawal state.
• Participant has had direct or indirect injury or trauma to the nervous system within 3 months before the onset of tremor.
• Participant is taking and unable to discontinue the use of primidone at least 7 days prior to administration of the first dose of SAGE-324.
• Participant has a history (within 3 years of Screening) or ongoing oncologic disease, excluding skin cancers (squamous or basal cell carcinoma) for which treatment has been completed and any carcinoma in situ.
• Participant has an ongoing clinically relevant medical or psychiatric condition that, in the judgment of the investigator, is not well managed and poses a risk for participation in the study.
• Participant has history of substance dependence and/or abuse 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.
• Participant has a known allergy to SAGE-324 or any excipient.
• Female participant has a positive pregnancy test or confirmed pregnancy or is breastfeeding.
• Participant has had exposure to another investigational drug or device within 30 days or 5 half-lives of the other investigational drug, whichever is longer, prior to the Day 1 visit and for the duration of the study.
• Participant has a history of suicidal behavior within 2 years or answers "YES" to questions 3, 4, or 5 on the C-SSRS at Screening or at Day 1 or is currently at risk of suicide in the opinion of the investigator.
• Participant has any condition or comorbidity that in the opinion of the investigator would limit or interfere with the participant's ability to complete or partake in the study.
• Participant has used any known moderate or strong cytochrome P450 3A4 inhibitors and/or inducers within 14 days or 5 half-lives (whichever is longer) prior to Day 1 or consumed grapefruit juice, grapefruit, Seville oranges, or St. John's Wort or products containing these within 30 days prior to Day 1 and is unwilling to refrain from taking these medications or foods for the duration of dosing. Use of mild cytochrome inhibitors and/or inducers may be permitted.

Sponsors & Collaborators

• Sage Therapeutics: lead

Study Sites (38)

Sage Investigational Site

Hoover, Alabama, 35244, United States

Location

Sage Investigational Site

Scottsdale, Arizona, 85258, United States

Location

Sage Investigational Site

Fountain Valley, California, 92708, United States

Location

Sage Investigational Site

Fullerton, California, 92835, United States

Location

Sage Investigational Site

Los Angeles, California, 90095, United States

Location

Sage Investigational Site

Englewood, Colorado, 80113, United States

Location

Sage Investigational Site

Boca Raton, Florida, 33486, United States

Location

Sage Investigational Site

Bradenton, Florida, 34205, United States

Location

Sage Investigational Site

Coral Springs, Florida, 33067, United States

Location

Sage Investigational Site

Hollywood, Florida, 33024, United States

Location

Sage Investigational Site

Miami, Florida, 33136, United States

Location

Sage Investigational Site

Miami, Florida, 33175, United States

Location

Sage Investigational Site

Miami, Florida, 33176, United States

Location

Sage Investigational Site

Naples, Florida, 34105, United States

Location

Sage Investigational Site

Orlando, Florida, 32803, United States

Location

Sage Investigational Site

Tampa, Florida, 33612, United States

Location

Sage Investigational Site

Atlanta, Georgia, 30329, United States

Location

Sage Investigational Site

Decatur, Georgia, 30030, United States

Location

Sage Investigational Site

Kansas City, Kansas, 66160, United States

Location

Sage Investigational Site

Lexington, Kentucky, 40509, United States

Location

Sage Investigational Site

Shreveport, Louisiana, 71105, United States

Location

Sage Investigational Site

Boston, Massachusetts, 02131, United States

Location

Sage Investigational Site

Farmington Hills, Michigan, 48334, United States

Location

Sage Investigational Site

New York, New York, 10003, United States

Location

Sage Investigational Site

New York, New York, 10032, United States

Location

Sage Investigational Site

Asheville, North Carolina, 28806, United States

Location

Sage Investigational Site

Cincinnati, Ohio, 45219, United States

Location

Sage Investigational Site

Dayton, Ohio, 45417, United States

Location

Sage Investigational Site

Tulsa, Oklahoma, 74136, United States

Location

Sage Investigational Site

Memphis, Tennessee, 38157, United States

Location

Sage Investigational Site

Austin, Texas, 78746, United States

Location

Sage Investigational Site

Fort Worth, Texas, 76104, United States

Location

Sage Investigational Site

Houston, Texas, 77030, United States

Location

Sage Investigational Site

Katy, Texas, 77450, United States

Location

Sage Investigational Site

Round Rock, Texas, 78681, United States

Location

Sage Investigational Site

West Falls Church, Virginia, 22042, United States

Location

Sage Investigational Site

Kirkland, Washington, 12039, United States

Location

Sage Investigational Site

Spokane, Washington, 99202, United States

Location

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Carrie Vaudreuil
• Organization: Sage Therapeutics

carrie.vaudreuil@sagerx.com

+1-857-259-4766

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 9, 2022
• Study Start: June 3, 2022
• Primary Completion: September 10, 2024
• Study Completion: September 10, 2024
• Last Updated: August 1, 2025
• Results First Posted: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (38)