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A Study to Evaluate SAGE-217 in Subjects With Essential Tremor

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ClinicalTrials.gov Identifier: NCT02978781
Recruitment Status : Completed
First Posted : December 1, 2016
Last Update Posted : November 26, 2018
Sponsor:
Information provided by (Responsible Party):
Sage Therapeutics

Brief Summary:
This study is a three-part, multicenter, Phase 2a study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of SAGE-217 in adult subjects with essential tremor.

Condition or disease Intervention/treatment Phase
Essential Tremor Drug: SAGE-217 Drug: Placebo Phase 2

Detailed Description:

Part A of the study is an open-label design with morning dosing of SAGE-217 for 7 days.

Part B of the study is a double-blind, placebo-controlled, randomized withdrawal design with morning dosing for 7 days.

Parts A and B of the study are closed to enrollment.

Part C of the study is an open-label design with evening dosing for 14 days.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2016
Actual Primary Completion Date : November 22, 2017
Actual Study Completion Date : December 5, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tremor

Arm Intervention/treatment
Experimental: SAGE-217 dosing
SAGE-217
Drug: SAGE-217
Placebo Comparator: Placebo
Placebo
Drug: Placebo



Primary Outcome Measures :
  1. Parts A and B: Effect of 7 days administration of SAGE-217 compared to placebo on the change in accelerometer-based Kinesia kinetic tremor combined score [ Time Frame: 7 days ]
  2. Part C: Effect of 14 days administration of SAGE-217 on the change in accelerometer-based Kinesia upper limb tremor combined score [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. Part A: Effect of 7 days administration of SAGE-217 compared to placebo on the change in accelerometer-based Kinesia upper limb total score and individual item scores [ Time Frame: 7 days ]
  2. Part A: Effect of 7 days administration of SAGE-217 compared to placebo in tremor severity as measured by the TRG Essential Tremor Rating Assessment Scale (TETRAS) [ Time Frame: 7 days ]
  3. Part B: Effect of 14 days administration of SAGE-217 on the change in accelerometer-based Kinesia upper limb total score and individual item scores [ Time Frame: 14 days ]
  4. Part B: Effect of 14 days administration of SAGE-217 in tremor severity as measured by the TRG Essential Tremor Rating Assessment Scale (TETRAS) [ Time Frame: 14 days ]
  5. Part C: Effect of 14 days administration of SAGE-217 on the change in accelerometer-based Kinesia upper limb individual item scores [ Time Frame: 14 days ]
  6. Part C: Effect of 14 days administration of SAGE-217 in tremor severity as measured by the TRG Essential Tremor Rating Assessment Scale (TETRAS) [ Time Frame: 14 days ]
  7. Parts A, B and C: Safety and tolerability, as assessed by vital signs measurements [ Time Frame: 28 days ]
  8. Parts A, B and C: Safety and tolerability, as assessed by clinical laboratory data [ Time Frame: 28 days ]
  9. Parts A, B and C: Safety and tolerability, as assessed by electrocardiogram (ECG) parameters [ Time Frame: 28 days ]
  10. Parts A, B and C: Safety and tolerability, as assessed by adverse event reporting [ Time Frame: 28 days ]
  11. Parts A, B and C: Safety and tolerability, as assessed by suicidal ideation using the Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 28 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Subject must have a diagnosis of ET, defined as bilateral postural tremor and kinetic tremor, involving hands and forearms, that is visible and persistent and the duration is >5 years prior to screening.

Key Exclusion Criteria:

  • Subject has presence of abnormal neurological signs other than tremor or Froment's sign.
  • Subject has presence of known causes of enhanced physiological tremor.
  • Subject has concurrent or recent exposure (14 days prior to admission visit) to tremorogenic drugs.
  • Subject has had direct or indirect trauma to the nervous system within 3 months before the onset of tremor.
  • Subject has historical or clinical evidence of tremor with psychogenic origin.
  • Subject has convincing evidence of sudden tremor onset or evidence of stepwise deterioration of tremor.

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): NCT02978781


Locations
United States, Alabama
Sage Investigational Site
Anniston, Alabama, United States, 36207
United States, Arkansas
Sage Investigational Site
Little Rock, Arkansas, United States, 72211
Sage Investigational Site
Rogers, Arkansas, United States, 72758
United States, California
Sage Investigational Site
Cerritos, California, United States, 90703
Sage Investigational Site
Fountain Valley, California, United States, 92708
Sage Investigational Site
Oceanside, California, United States, 92056
Sage Investigational Site
San Diego, California, United States, 92103
United States, Colorado
Sage Investigational Site
Englewood, Colorado, United States, 80113
United States, Florida
Sage Investigational Site
Clearwater, Florida, United States, 33756
Sage Investigational Site
DeLand, Florida, United States, 32720
Sage Investigational Site
Lauderdale Lakes, Florida, United States, 33319
Sage Investigational Site
Orlando, Florida, United States, 32806
Sage Investigational Site
Ormond Beach, Florida, United States, 32174
Sage Investigational Site
Saint Petersburg, Florida, United States, 33713
Sage Investigational Site
Tampa, Florida, United States, 33612
United States, Georgia
Sage Investigational Site
Atlanta, Georgia, United States, 30331
Sage Investigational Site
Decatur, Georgia, United States, 30030
United States, Illinois
Sage Investigational Site
Chicago, Illinois, United States, 60612
Sage Investigational Site
Urbana, Illinois, United States, 61801
United States, Missouri
Sage Investigational Site
Saint Louis, Missouri, United States, 63141
Sage Investigational Site
Springfield, Missouri, United States, 65802
United States, North Carolina
Sage Investigational Site
Raleigh, North Carolina, United States, 27612
United States, Ohio
Sage Investigational Site
Cincinnati, Ohio, United States, 45212
Sage Investigational Site
Dayton, Ohio, United States, 45417
United States, Tennessee
Sage Investigational Site
Nashville, Tennessee, United States, 37232
United States, Texas
Sage Investigational Site
Fort Worth, Texas, United States, 76104
Sponsors and Collaborators
Sage Therapeutics
Investigators
Study Director: Christopher Silber, MD Sage Therapeutics

Additional Information:
Responsible Party: Sage Therapeutics
ClinicalTrials.gov Identifier: NCT02978781     History of Changes
Other Study ID Numbers: 217-ETD-201
First Posted: December 1, 2016    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018

Keywords provided by Sage Therapeutics:
Tremor

Additional relevant MeSH terms:
Tremor
Essential Tremor
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases