Evaluate SAGE-547 in Patients With Essential Tremor
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ClinicalTrials.gov Identifier: NCT02277106 |
Recruitment Status :
Completed
First Posted : October 28, 2014
Last Update Posted : April 26, 2017
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Stage 1 is a double-blind, proof-of-concept study designed to evaluate the safety, tolerability, PK, and efficacy of SAGE-547 Injection in male and female patients with essential tremor in the upper limb.
Stage 2 is an open-label arm designed to evaluate the safety, tolerability, PK, and effeciveness of SAGE-547 Injection at a higher dose than in Stage 1. Subjects who completed Stage 1 will be invited to participate in Stage 2.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Essential Tremor | Drug: SAGE-547 Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | September 2014 |
Actual Primary Completion Date : | August 2015 |
Actual Study Completion Date : | August 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: SAGE-547
Intravenous
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Drug: SAGE-547 |
Placebo Comparator: Placebo
Intravenous sterile saline
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Drug: Placebo |
- Safety and tolerability of SAGE-547 [ Time Frame: 46 days ]
- Effect of SAGE-547 on patient response as measured by accelerometer (transducer measurement of tremor amplitude) [ Time Frame: 24 hours ]
- Effect of SAGE-547 on patient response as measured globally by The Essential Tremor Rating Scale (TETRAS) [ Time Frame: 24 hours ]
- Pharmacokinetic (PK) profile of SAGE-547 as measured by AUC, Cmax, Tmax, Css, and Cavg [ Time Frame: 24 hours ]

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Ages Eligible for Study: | 35 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Males and females, 35-75 years old with a diagnosis of essential tremor with symptoms clearly present in at least 1 upper limb; patient has had tremor present for at least 2 years prior to Screening
- Off medication, or on a stable dose of medication for their tremor for at least 28 days prior to Screening
Exclusion Criteria:
- Recent history or active clinically significant manifestations of metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, musculoskeletal, dermatological, urogenital, eyes, ears, nose, or throat, psychiatric, or neurological (other than essential tremor) disorders
- Medical history of seizures

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02277106
United States, Michigan | |
Sage Study Site | |
Bingham Farms, Michigan, United States | |
United States, North Carolina | |
Sage Study Site | |
Raleigh, North Carolina, United States |
Study Chair: | Stephen J Kanes, MD, PhD | Sage Therapeutics |
Responsible Party: | Sage Therapeutics |
ClinicalTrials.gov Identifier: | NCT02277106 |
Other Study ID Numbers: |
547-ETD-201 |
First Posted: | October 28, 2014 Key Record Dates |
Last Update Posted: | April 26, 2017 |
Last Verified: | April 2017 |
Tremor Essential Tremor Dyskinesias Neurologic Manifestations |
Nervous System Diseases Movement Disorders Central Nervous System Diseases |