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

• Status: Completed
• Trial end date: 2017-09-11
• Target enrollment: 0
• Participant gender: All

Summary

This study assesses the safety, tolerability, pharmacokinetics and efficacy of SAGE-217 in 29 participants with moderate to severe Parkinson's Disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sage Therapeutics
• Treatments: Antiparkinson Agents; Levodopa

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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