A Study to Evaluate SAGE-217 in Participants With Parkinson's Disease
NCT ID: NCT03000569
Last Updated: 2023-11-29
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
29 participants
INTERVENTIONAL
2016-11-30
2017-09-11
Brief Summary
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Detailed Description
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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).
This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part A: Antiparkinsonian Agent(s) Followed by SAGE-217
Participants on a stable morning dose of levodopa (including carbidopa-levodopa) as antiparkinsonian agent(s) from Days 1 to 3, stopped levodopa and received SAGE-217 at a dose of 30 mg per day, oral solution, for Days 4 to 7 in the morning with food. Stable doses of other antiparkinsonian agents and dose reductions in SAGE-217 were allowed between Days 1 to 7. Participants resumed stable morning dose of levodopa from Days 8 to 14.
SAGE-217
Levodopa
Levodopa (including carbidopa-levodopa) administered as antiparkinsonian agent(s).
Part B: Antiparkinsonian Agent(s) + SAGE-217
Participants on a stable dose of antiparkinsonian agent(s) received SAGE-217, up to 30 mg per day, capsules, for Days 1 to 7 in the evening with food.
SAGE-217
Antiparkinsonian Agent(s)
Antiparkinsonian agent(s) were administered as a clinical practice as standard of care, which includes levodopa (i.e. levodopa/carbidopa) or dopamine agonists or catechol-O-methyltransferase (COMT) inhibitors or monoamine oxidase (BMAO-B) inhibitors.
Interventions
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SAGE-217
Levodopa
Levodopa (including carbidopa-levodopa) administered as antiparkinsonian agent(s).
Antiparkinsonian Agent(s)
Antiparkinsonian agent(s) were administered as a clinical practice as standard of care, which includes levodopa (i.e. levodopa/carbidopa) or dopamine agonists or catechol-O-methyltransferase (COMT) inhibitors or monoamine oxidase (BMAO-B) inhibitors.
Eligibility Criteria
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Inclusion Criteria
* Participant has a diagnosis of idiopathic Parkinson's Disease (Hoehn and Yahr Stage 1-4, assessed during the "on" period) \[Part B\]
* Participant 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
* Participant has advanced (Hoehn and Yahr Stage 5) Parkinson's Disease \[Part B\]
* Participant with presence of drug-induced parkinsonism, metabolic identified neurogenetic disorders, encephalitis, or other atypical Parkinsonian syndromes
* Participant with medical history of electroconvulsive therapy or stereotaxic brain surgery for Parkinson's Disease
* Participant with medical history of suicide attempt within 2 years of screening or current suicidal ideation
* Participant with medical history of impulse control disorder
40 Years
75 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Locations
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Sage Investigational Site
Panorama City, California, United States
Sage Investigational Site
Jacksonville, Florida, United States
Sage Investigational Site
Miami, Florida, United States
Sage Investigational Site
Miami, Florida, United States
Sage Investigational Site
Orlando, Florida, United States
Sage Investigational Site
Winter Park, Florida, United States
Sage Investigational Site
Atlanta, Georgia, United States
Sage Investigational Site
Farmington Hills, Michigan, United States
Sage Investigational Site
Berlin, New Jersey, United States
Sage Investigational Site
Houston, Texas, United States
Sage Investigational Site
Orem, Utah, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan: Version 2
Document Type: Statistical Analysis Plan: Version 1
Related Links
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Related Info
Other Identifiers
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217-PRK-201
Identifier Type: -
Identifier Source: org_study_id