CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 29 enrolled
Drug / intervention
SAGE-217 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03000569
NCT03000569Phase 2Completed

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

Biogen·interventional·Posted Dec 22, 2016·Updated Nov 29, 2023

In Brief

A Phase 2 clinical trial evaluating SAGE-217, Levodopa, and 1 other intervention for Parkinson Disease. Completed, enrolled 29 participants across 11 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 22, 2016
Enrollment StartNov 30, 2016
Primary CompletionSep 11, 2017
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 9.5 years ago

Interventions

SAGE-217drug

Levodopadrug

Levodopa (including carbidopa-levodopa) administered as antiparkinsonian agent(s).

Antiparkinsonian Agent(s)drug

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.