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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02978781
Study type	Interventional
Source	Biogen
Contact
Status	Completed
Phase	Phase 2
Start date	March 24, 2017
Completion date	December 5, 2017

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