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



Status:Completed
Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:40 - 75
Updated:10/13/2018
Start Date:December 2016
End Date:September 18, 2017

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A Phase 2, Two-Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SAGE-217 in Subjects With Parkinson's Disease

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.

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).

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
We found this trial at
10
sites
Orem, Utah 84058
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Atlanta, Georgia 30303
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Atlanta, GA
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Berlin, New Jersey 08009
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Berlin, NJ
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Farmington Hills, Michigan 48334
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Houston, Texas 77058
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Houston, TX
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Jacksonville, Florida 32209
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Jacksonville, FL
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Miami, Florida 33155
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Orlando, Florida 32803
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Orlando, FL
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Panorama City, California 91402
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Panorama City, CA
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Winter Park, Florida 32789
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Winter Park, FL
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