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NCT05366751 | Recruiting | Essential Tremor

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

Sage Therapeutics

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).

Condition or disease

Essential Tremor

Intervention/treatment

SAGE-324

Phase

Phase 2

Phase 3

Study Type : Interventional
Estimated Enrollment : 750 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : An Open-label Study of the Long-term Safety and Tolerability of SAGE-324 in Participants With Essential Tremor
Actual Study Start Date : June 13, 2022
Estimated Primary Completion Date : September 2027
Estimated Study Completion Date : September 2027
Arm Intervention/treatment

Experimental: SAGE-324 60 mg

Participants will receive SAGE-324 oral tablets from Day 1 to the End of Treatment (EOT) Period at a starting dose of 15 milligrams (mg). The dose will be up titrated in 15 mg increments to 60 mg. In case of intolerable adverse events, the dose will be down titrated in 15 mg decrements.

Drug: SAGE-324
Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • 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 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 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 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.
    Exclusion Criteria
    • 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, (unless prescribed) or has a positive screen for alcohol or cotinine 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.
A Study to Evaluate the Long-term Safety and Tolerability of SAGE-324 in Participants With Essential Tremor

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

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Locations

Recruiting

United States, Alabama

Sage Investigational Site

Hoover, alabama, United States, 35244

Recruiting

United States, Arizona

Sage Investigational Site

Scottsdale, Arizona, United States, 85258

Recruiting

United States, California

Sage Investigational Site

Fountain Valley, California, United States, 92708

Recruiting

United States, California

Sage Investigational Site

Fullerton, California, United States, 92835

Recruiting

United States, Florida

Sage Investigational Site

Boca Raton, florida, United States, 33486

Recruiting

United States, Florida

Sage Investigational Site

Coral Springs, florida, United States, 33067

Recruiting

United States, Florida

Sage Investigational Site

Hollywood, florida, United States, 33024

Recruiting

United States, Florida

Sage Investigational Site

Miami, florida, United States, 33136

Recruiting

United States, Florida

Sage Investigational Site

Miami, florida, United States, 33176

Recruiting

United States, Florida

Sage Investigational Site

Naples, florida, United States, 34105

Recruiting

United States, Florida

Sage Investigational Site

Tampa, florida, United States, 33612

Recruiting

United States, Georgia

Sage Investigational Site

Decatur, Georgia, United States, 30030

Recruiting

United States, Kansas

Sage Investigational Site

Kansas City, Kansas, United States, 66160

Recruiting

United States, Louisiana

Sage Investigational Site

Shreveport, Louisiana, United States, 71105

Recruiting

United States, Massachusetts

Sage Investigational Site

Boston, Massachusetts, United States, 02131

Recruiting

United States, road cancer

Sage Investigational Site

Farmington Hills, road cancer, United States, 48334

Recruiting

United States, New York

Sage Investigational Site

New York, New York, United States, 10003

Recruiting

United States, North Carolina

Sage Investigational Site

Asheville, North Carolina, United States, 28806

Recruiting

United States, Ohio

Sage Investigational Site

Cincinnati, Ohio, United States, 45219

Recruiting

United States, Ohio

Sage Investigational Site

Dayton, Ohio, United States, 45417

Recruiting

United States, Oklahoma

Sage Investigational Site

Tulsa, Oklahoma, United States, 74136

Recruiting

United States, Tennessee

Sage Investigational Site

Memphis, Tennessee, United States, 38157

Recruiting

United States, Texas

Sage Investigational Site

Austin, Texas, United States, 78746

Recruiting

United States, Texas

Sage Investigational Site

Fort Worth, Texas, United States, 76104

Recruiting

United States, Texas

Sage Investigational Site

Houston, Texas, United States, 77030

Recruiting

United States, Texas

Sage Investigational Site

Katy, Texas, United States, 77450

Recruiting

United States, Texas

Sage Investigational Site

Round Rock, Texas, United States, 78681

Recruiting

United States, Washington

Sage Investigational Site

Spokane, Washington, United States, 99202