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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05366751
Recruitment Status : Recruiting
First Posted : May 9, 2022
Last Update Posted : September 29, 2023
Sponsor:
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 long-term safety and tolerability of SAGE-324 in participants with essential tremor (ET).

Condition or disease Intervention/treatment Phase
Essential Tremor Drug: SAGE-324 Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
SAGE-324 oral tablets


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With at least One Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to approximately 5 years ]
    An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A TEAE is defined as an AE with onset after the first dose of an investigational product (IP).


Secondary Outcome Measures :
  1. Percentage of Participants With Change from Baseline in Vital Sign Parameters [ Time Frame: Baseline up to approximately 5 years ]
    Vital signs assessment will include heart rate, respiratory rate, temperature, and blood pressure.

  2. Percentage of Participants With Change from Baseline in Electrocardiogram (ECG) Parameters [ Time Frame: Baseline up to approximately 5 years ]
  3. Percentage of Participants With Change from Baseline in Clinical Laboratory Parameters [ Time Frame: Baseline up to approximately 5 years ]
    The clinical laboratory parameters will include biochemistry, coagulation, hematology, urinalysis assessments.

  4. Percentage of Participants With Change from Baseline in Epworth Sleepiness Scale (ESS) Score [ Time Frame: Baseline up to approximately 5 years ]
    The ESS is a quick, 8-item, self-administered questionnaire where participants rate, on a 4-point scale (0 low to 3 high), their usual chances of dozing off or falling asleep while engaged in 8 different activities. The total ESS score estimates the participant's average sleep propensity, across a range of activities in their daily lives. The ESS score can range from 0 to 24. ESS score ≥ 10 will be used to indicate excessive daytime sleepiness. A higher score indicates more severe excessive daytime sleepiness.

  5. Percentage of Participants With Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) Responses [ Time Frame: Baseline up to approximately 5 years ]
    This C-SSRS scale consists of a baseline evaluation that assesses the lifetime experience of the participant with suicidal ideation and behavior, and a post-baseline evaluation that focuses on suicidality since the last study visit. The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe). A higher score indicates more severe symptom.

  6. Physician Withdrawal Checklist (PWC-20) Scale Score [ Time Frame: Baseline up to approximately 5 years ]
    The Physician Withdrawal Checklist (PWC) is based on the 35-item Penn Physician Withdrawal Checklist that was developed to measure benzodiazepine and benzodiazepine-like discontinuation symptoms. The PWC-20 is made up of a list of 20 symptoms (eg, loss of appetite, nausea-vomiting, diarrhea, anxiety-nervousness, irritability) that are rated on a scale of 0 (not present) to 3 (severe). Total scores can range from 0 to 60 with higher scores indicating more severe symptoms. A higher score indicates more severe symptom.


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. 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.

  2. Participant has a clinician-confirmed diagnosis of ET in compliance with all the following criteria:

    1. Duration of at least 3 years
    2. 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
    3. Absence of historical or clinical evidence of tremor with psychogenic origin (including, but not limited to, eating disorders and major depression)
  3. Participant has completed the planned EOT visit and was not early terminated during the planned Treatment Period in another SAGE-324 study.

  4. 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.

    1. Participant will limit alcohol use to at least 2 hours before self-administration of IP in the evening.
    2. Participant will not use alcohol starting 24 hours prior to scheduled in-clinic study visits until all assessments have been completed.
  5. 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:

  1. Participant has presence of alcohol withdrawal state.
  2. Participant has had direct or indirect injury or trauma to the nervous system within 3 months before the onset of tremor.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. Participant has a known allergy to SAGE-324 or any excipient.
  8. Female participant has a positive pregnancy test or confirmed pregnancy or is breastfeeding.
  9. 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.
  10. 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.
  11. 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.
  12. 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.
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): NCT05366751


Contacts
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Contact: Carrie Vaudreuil, MD 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, Arizona
Sage Investigational Site Recruiting
Scottsdale, Arizona, United States, 85258
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
Coral Springs, Florida, United States, 33067
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
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, Kansas
Sage Investigational Site Recruiting
Kansas City, Kansas, United States, 66160
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Louisiana
Sage Investigational Site Recruiting
Shreveport, Louisiana, United States, 71105
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
More Information
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Responsible Party: Sage Therapeutics
ClinicalTrials.gov Identifier: NCT05366751    
Other Study ID Numbers: 324-ETD-303
First Posted: May 9, 2022    Key Record Dates
Last Update Posted: September 29, 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:
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