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A Study to Evaluate SAGE-217 in Subjects With Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT03000569
Recruitment Status : Completed
First Posted : December 22, 2016
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
Sage Therapeutics

Brief Summary:
This study will assess the safety, tolerability, pharmacokinetics and efficacy of SAGE-217 in up to 30 subjects with Parkinson's Disease of Moderate Severity.

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: SAGE-217 Drug: Antiparkinson Agents Phase 2

Detailed Description:

Part A of the study is an open-label design with dosing of Levodopa for 3 days followed by SAGE-217 for 4 days.

Part B of the study is an open-label design with evening dosing of SAGE-217 for 7 days as an adjunct to antiparkinsonian agent(s).


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Two-Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SAGE-217 in Subjects With Parkinson's Disease
Study Start Date : December 2016
Actual Primary Completion Date : September 18, 2017
Actual Study Completion Date : September 18, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Combination Arm
SAGE-217 and antiparkinsonian agent(s)
Drug: SAGE-217 Drug: Antiparkinson Agents



Primary Outcome Measures :
  1. Safety and tolerability, as assessed by adverse events [Part A] [ Time Frame: 14 days ]
  2. Safety and tolerability, as assessed by vital signs [Part A] [ Time Frame: 14 days ]
  3. Safety and tolerability, as assessed by clinical laboratory data [Part A] [ Time Frame: 14 days ]
  4. Safety and tolerability, as assessed by electrocardiograms (ECGs) [Part A] [ Time Frame: 14 days ]
  5. Safety and tolerability, as assessed by suicidal ideation using the Columbia-Suicide Severity Rating Scale (C-SSRS) [Part A] [ Time Frame: 14 days ]
  6. Effect of SAGE-217 on improvement in PD tremor as assessed by changes in the MDS-UPDRS - Part II/III score [Part B] [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. Effect of SAGE-217 compared to placebo on improvement in PD motor symptoms as assessed by changes in the MDS-UPDRS - Part III score [Parts A and B] [ Time Frame: 14 days ]
  2. Safety and tolerability, as assessed by adverse events [Part B] [ Time Frame: 14 days ]
  3. Safety and tolerability, as assessed by vital signs [Part B] [ Time Frame: 14 days ]
  4. Safety and tolerability, as assessed by clinical laboratory data [Part B] [ Time Frame: 14 days ]
  5. Safety and tolerability, as assessed by electrocardiograms (ECGs) [Part B] [ Time Frame: 14 days ]
  6. Safety and tolerability, as assessed by suicidal ideation using the Columbia-Suicide Severity Rating Scale (C-SSRS) [Part B] [ Time Frame: 14 days ]


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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has a diagnosis of idiopathic Parkinson's Disease (Hoehn and Yahr Stage 2 or Stage 3) with a duration of less than 7 years prior to screening [Part A]
  • Subject has a diagnosis of idiopathic Parkinson's Disease (Hoehn and Yahr Stage 1-4) [Part B]
  • Subject is on a stable dose (at least 1 month prior to baseline visit) of an antiparkinsonian agent and is willing to remain on this dose for the duration of the study

Exclusion Criteria:

  • Subject has early (Hoehn and Yahr Stage 1) or advanced (Hoehn and Yahr Stage 4 or Stage 5) Parkinson's Disease [Part A]
  • Subject has advanced (Hoehn and Yahr Stage 5) Parkinson's Disease [Part B]
  • Subject with presence of drug-induced parkinsonism, metabolic identified neurogenetic disorders, encephalitis, or other atypical Parkinsonian syndromes
  • Medical history of electroconvulsive therapy or stereotaxic brain surgery for Parkinson's Disease
  • Medical history of suicide attempt within 2 years of screening or current suicidal ideation
  • Medical history of impulse control disorder

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): NCT03000569


Locations
United States, California
Sage Investigational Site
Panorama City, California, United States, 91402
United States, Florida
Sage Investigational Site
Jacksonville, Florida, United States, 32216
Sage Investigational Site
Miami, Florida, United States, 33135
Sage Investigational Site
Miami, Florida, United States, 33143
Sage Investigational Site
Orlando, Florida, United States, 32806
Sage Investigational Site
Winter Park, Florida, United States, 32789
United States, Georgia
Sage Investigational Site
Atlanta, Georgia, United States, 30331
United States, Michigan
Sage Investigational Site
Farmington Hills, Michigan, United States, 48334
United States, New Jersey
Sage Investigational Site
Berlin, New Jersey, United States, 08009
United States, Texas
Sage Investigational Site
Houston, Texas, United States, 77058
United States, Utah
Sage Investigational Site
Orem, Utah, United States, 84058
Sponsors and Collaborators
Sage Therapeutics
Investigators
Study Director: Christopher Silber, MD Sage Therapeutics

Additional Information:
Responsible Party: Sage Therapeutics
ClinicalTrials.gov Identifier: NCT03000569     History of Changes
Other Study ID Numbers: 217-PRK-201
First Posted: December 22, 2016    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017

Keywords provided by Sage Therapeutics:
Parkinson

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Antiparkinson Agents
Anti-Dyskinesia Agents