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 |
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.
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).
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
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