Overview

Study to Evaluate SAGE-324 in Participants With Essential Tremors

Status:
Not yet recruiting
Trial end date:
2023-06-01
Target enrollment:
0
Participant gender:
All
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 tremors (ET).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sage Therapeutics
Collaborator:
Biogen
Criteria
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. Scores of at least 12 in the combined total upper limb TETRAS (total Performance
Subscale Item 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) of at
least 6, 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 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 enhanced 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 (including, but not
limited to, eating disorders and major depression)