Evaluate SAGE-547 in Patients With Essential Tremor
Evaluate SAGE-547 in Patients With Essential Tremor
Stage 1 is a double-blind, proof-of-concept study designed to evaluate the safety,
 tolerability, PK, and efficacy of SAGE-547 Injection in male and female patients with
 essential tremor in the upper limb.

 Stage 2 is an open-label arm designed to evaluate the safety, tolerability, PK, and
 effeciveness of SAGE-547 Injection at a higher dose than in Stage 1. Subjects who completed
 Stage 1 will be invited to participate in Stage 2.
Inclusion Criteria:

 -  Males and females, 35-75 years old with a diagnosis of essential tremor with symptoms
 clearly present in at least 1 upper limb; patient has had tremor present for at least
 2 years prior to Screening

 -  Off medication, or on a stable dose of medication for their tremor for at least 28
 days prior to Screening

 Exclusion Criteria:

 -  Recent history or active clinically significant manifestations of metabolic, hepatic,
 renal, hematological, pulmonary, cardiovascular, gastrointestinal, musculoskeletal,
 dermatological, urogenital, eyes, ears, nose, or throat, psychiatric, or neurological
 (other than essential tremor) disorders

 -  Medical history of seizures