Trials / Completed
CompletedNCT02277106
Evaluate SAGE-547 in Participants With Essential Tremor
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Sage Therapeutics · Industry
- Sex
- All
- Age
- 35 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SAGE-547 | |
| DRUG | Placebo |
Timeline
- Start date
- 2014-09-23
- Primary completion
- 2015-08-14
- Completion
- 2015-08-14
- First posted
- 2014-10-28
- Last updated
- 2022-06-29
- Results posted
- 2022-06-29
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02277106. Inclusion in this directory is not an endorsement.