A Study to Evaluate SAGE-217 in Participants With Essential Tremor

A Phase 2a, Double-Blind, Placebo-Controlled, Randomized Withdrawal Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of SAGE-217 in the Treatment of Subjects 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).

This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.

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.