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

NCT ID: NCT04305275

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-19
• Study Completion Date: 2021-02-15

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 (UL) tremor reduction in individuals with essential tremor (ET).

Conditions

Essential Tremor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SAGE-324 60 mg

Participants received SAGE-324, 60 milligrams (mg), oral tablets, once daily (QD), in the morning for 28 days.

Group Type: EXPERIMENTAL

SAGE-324

Intervention Type: DRUG

SAGE-324 oral tablet

SAGE-324 Matched Placebo

Participants received SAGE-324 matched placebo, oral tablets, QD, in the morning for 28 days.

Group Type: PLACEBO_COMPARATOR

SAGE-324 Placebo

Intervention Type: DRUG

SAGE-324 matched placebo oral tablet

Interventions

SAGE-324 Placebo

SAGE-324 matched placebo oral tablet

Intervention Type: DRUG

SAGE-324

SAGE-324 oral tablet

Intervention Type: DRUG

Eligibility 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 (e.g., 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 the essential tremor rating assessment scale (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 pre-dose 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 investigational product (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, e.g., 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 organic anion transporting polypeptide 1B1 (OATP1B1) transporter.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sage Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sage Investigational Site

Phoenix, Arizona, United States

Sage Investigational Site

Rogers, Arkansas, United States

Sage Investigational Site

Fresno, California, United States

Sage Investigational Site

Long Beach, California, United States

Sage Investigational Site

Englewood, Colorado, United States

Sage Investigational Site

Boca Raton, Florida, United States

Sage Investigational Site

Gainesville, Florida, United States

Sage Investigational Site

Hollywood, Florida, United States

Sage Investigational Site

Miami, Florida, United States

Sage Investigational Site

Miami, Florida, United States

Sage Investigational Site

Port Charlotte, Florida, United States

Sage Investigational Site

St. Petersburg, Florida, United States

Sage Investigational Site

Tampa, Florida, United States

Sage Investigational Site

Decatur, Georgia, United States

Sage Investigational Site

Savannah, Georgia, United States

Sage Investigational Site

Springfield, Illinois, United States

Sage Investigational Site

Kansas City, Kansas, United States

Sage Investigational Site

Farmington Hills, Michigan, United States

Sage Investigational Site

New York, New York, United States

Sage Investigational Site

Asheville, North Carolina, United States

Sage Investigational Site

Cincinnati, Ohio, United States

Sage Investigational Site

Dayton, Ohio, United States

Sage Investigational Site

Tulsa, Oklahoma, United States

Sage Investigational Site

Houston, Texas, United States

Sage Investigational Site

Richmond, Virginia, United States

Sage Investigational Site

Spokane, Washington, United States

Sage Investigational Site

Huntington, West Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

324-ETD-201

Identifier Type: -

Identifier Source: org_study_id