Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Biogen
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).
This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.
Age
40–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participant 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 \[Part A\]
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
You may not be if
Participant has early (Hoehn and Yahr Stage 1) or advanced (Hoehn and Yahr Stage 4 or Stage 5) Parkinson's Disease \[Part A\]
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
Clareo Health | A Study to Evaluate SAGE-217 in Participants With Parkinson's Disease
