drugset / Trial / NCT03521635

The SUSTAIN Study Compares the Effects of Sustained and Immediate-release Pramipexole on the noctUrnal Symptoms of paTients With Advanced ParkInsoN's Disease Who Also Take L-Dopa

NCT03521635

Phase 4 Completed 98 enrolled Boehringer Ingelheim
RandomizedParallel-groupOpen-labelTreatment

Summary

The main objective of the study is to explore firstly, then further evaluate and confirm the efficacy between Pramipexole Sustained Release (SR) versus Pramipexole Immediate Release (IR) on nocturnal symptoms (as measured by the change from baseline to the end of the maintenance period in Parkinson's Disease Sleep Scale 2nd version (PDSS-2) score) in L-dopa+ treated patients with advanced Parkinson's disease (PD).

Timeline

Start
2018-07-03
Primary completion
2020-01-07
Completion
2020-01-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Pramipexole Unknown Oral

Indications