At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 25 enrolled
Drug / intervention
SAGE-547 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-blind, Placebo-controlled, Two-Period Crossover Proof-of-Concept Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of SAGE-547 Injection in the Treatment of Patients With Essential Tremor
In Brief
A Phase 2 clinical trial evaluating SAGE-547 and Placebo for Essential Tremor. Completed, enrolled 25 participants across 2 sites.
Detailed Summary
Stage 1 is a double-blind, proof-of-concept study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of SAGE-547 Injection in male and female participants with essential tremor in the upper limb. Stage 2 is an open-label arm designed to evaluate the safety, tolerability, PK, and effectiveness of SAGE-547 Injection at a higher dose than in Stage 1. Participants who completed Stage 1 were invited to participate in Stage 2.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEssential Tremor
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartSep 2014
First PostedOct 2014
Primary CompletionAug 2015
TodayJul 2026
First PostedOct 28, 2014
Enrollment StartSep 23, 2014
Primary CompletionAug 14, 2015
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 11.7 years ago
Interventions
SAGE-547drug
Placebodrug