NCT02978781

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Essential Tremor

Interventions

Type	Name	Description
DRUG	SAGE-217	SAGE-217 Oral Solution
DRUG	SAGE-217	SAGE-217 Capsules
DRUG	Placebo	SAGE-217 matching placebo capsules

Timeline

• Start date: 2017-03-24
• Primary completion: 2017-11-22
• Completion: 2017-12-05
• First posted: 2016-12-01
• Last updated: 2023-11-28
• Results posted: 2021-02-17

Locations

26 sites across 1 country: United States

Regulatory

• FDA-regulated drug study