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Evaluate SAGE-547 in Patients With Essential Tremor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02277106
Recruitment Status : Completed
First Posted : October 28, 2014
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Sage Therapeutics

Brief Summary:

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tremor

Arm Intervention/treatment
Experimental: SAGE-547
Intravenous
Drug: SAGE-547
Placebo Comparator: Placebo
Intravenous sterile saline
Drug: Placebo



Primary Outcome Measures :
  1. Safety and tolerability of SAGE-547 [ Time Frame: 46 days ]

Secondary Outcome Measures :
  1. Effect of SAGE-547 on patient response as measured by accelerometer (transducer measurement of tremor amplitude) [ Time Frame: 24 hours ]
  2. Effect of SAGE-547 on patient response as measured globally by The Essential Tremor Rating Scale (TETRAS) [ Time Frame: 24 hours ]
  3. Pharmacokinetic (PK) profile of SAGE-547 as measured by AUC, Cmax, Tmax, Css, and Cavg [ Time Frame: 24 hours ]


Information from the National Library of Medicine

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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
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, Michigan
Sage Study Site
Bingham Farms, Michigan, United States
United States, North Carolina
Sage Study Site
Raleigh, North Carolina, United States
Sponsors and Collaborators
Sage Therapeutics
Investigators
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Study Chair: Stephen J Kanes, MD, PhD Sage Therapeutics

Additional Information:
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Responsible Party: Sage Therapeutics
ClinicalTrials.gov Identifier: NCT02277106     History of Changes
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
Additional relevant MeSH terms:
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Tremor
Essential Tremor
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Pregnanolone
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs