A Study to Evaluate SAGE-217 in Participants With Essential Tremor
A Study to Evaluate SAGE-217 in Participants With Essential Tremor
This study is a three-part, multicenter, Phase 2a study to evaluate the efficacy, safety,
 tolerability, and pharmacokinetics of SAGE-217 in adult participants with essential tremor.
Part A of the study was an open-label design with morning dosing of SAGE-217 for 7 days and
 included 16 participants, 8 of whom qualified for, and entered, Part B.

 Part B had a double-blind, placebo-controlled, randomized withdrawal design with morning
 dosing for 7 days.

 Part C was an open-label design with morning and evening dosing for 14 days and included a
 different set of 18 participants.

 Parts A and B were stopped early (in advance of the planned sample size).
Key Inclusion Criteria:

 -  Participant must have a diagnosis of Essential Tremor (ET), defined as bilateral
 postural tremor and kinetic tremor, involving hands and forearms, that is visible and
 persistent and the duration is >5 years prior to screening.

 Key Exclusion Criteria:

 -  Participant has presence of abnormal neurological signs other than tremor or Froment's
 sign.

 -  Participant has presence of known causes of enhanced physiological tremor.

 -  Participant has concurrent or recent exposure (14 days prior to admission visit) to
 tremorogenic drugs.

 -  Participant has had direct or indirect trauma to the nervous system within 3 months
 before the onset of tremor.

 -  Participant has historical or clinical evidence of tremor with psychogenic origin.

 -  Participant has convincing evidence of sudden tremor onset or evidence of stepwise
 deterioration of tremor.