NCT03000569

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	SAGE-217
DRUG	Levodopa	Levodopa (including carbidopa-levodopa) administered as antiparkinsonian agent(s).
DRUG	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.

Timeline

• Start date: 2016-11-30
• Primary completion: 2017-09-11
• Completion: 2017-09-11
• First posted: 2016-12-22
• Last updated: 2023-11-29
• Results posted: 2020-11-23

Locations

11 sites across 1 country: United States