A Two- Stage Multicenter, Open-label, Randomized, Active Controlled Parallel Group Study Comparing the Efficacy and Safety of Pramipexole SR Versus Pramipexole IR Administered Orally Over an 18-week Treatment on Nocturnal Symptoms in L-Dopa+ Treated Patients With Advanced Parkinson's Disease (PD)

Boehringer Ingelheim12 sites in 1 country98 target enrollmentJuly 3, 2018

ConditionsParkinson Disease

InterventionsPramipexole SR Pramipexole IR

DrugsPramipexole SR Pramipexole IR

Overview

Phase: Phase 4
Intervention: Pramipexole SR
Conditions: Parkinson Disease
Sponsor: Boehringer Ingelheim
Enrollment: 98
Locations: 12
Primary Endpoint: Change From Baseline to Week 18 in Parkinson's Disease Sleep Scale 2nd Version (PDSS-2) Total Score
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

July 3, 2018

End Date

January 7, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female patient with advanced idiopathic Parkinson's disease (PD) confirmed by at least bradykinesia and one of the following signs: resting tremor, rigidity.
•Diagnosed as Parkinson's disease, with at least 2 years' PD history.
•Of age ≥ 30 years at time of diagnosis.
•Modified Hoehn and Yahr stage of 2 to 4 at on-time.
•They must have clinically relevant sleep disturbances (i.e. Parkinson's Disease Sleep Scale 2nd version (PDSS-2) total score ≥18 at baseline).
•They must feel uncomfortable at night because they were unable to turn around in bed or move due to immobility (i.e. the scoring of question 9 in PDSS-2 ≥ 2, that means frequency is at least 2 to 3 days during the past week).
•They must have early morning off (i.e. the frequency of "feeling like bodily movements are poor when you wake up?" is at least 2 to 3 days during the past week).
•Patient must have motor fluctuations (at least 2 cumulative hours of off-time every day during waking hours, documented on a patient diary completed for 2 consecutive days before randomization visit).
•Patients must be treated with Levodopa combined with a Dopa-Decarboxylase-inhibitor (L-Dopa+) (i.e. standard and/or controlled release Levodopa/DDC inhibitor), or with a combination of L-Dopa+ and entacapone, at an optimized dose according to investigator's judgment, this dose being stable for at least 4 weeks prior to randomization visit.
•Patients must not have been treated with sustained release dopaminergic drug (i.e. sustained release Levodopa/Dopa-Decarboxylase (DDC) inhibitor) after supper, or any anti-PD medication after 9pm within 4 weeks prior to randomization visit.

Exclusion Criteria

Not provided

Arms & Interventions

Pramipexole SR

Intervention: Pramipexole SR

Pramipexole IR

Intervention: Pramipexole IR

Outcomes

Primary Outcomes

Change From Baseline to Week 18 in Parkinson's Disease Sleep Scale 2nd Version (PDSS-2) Total Score

Time Frame: Baseline and Week 18

Parkinson's disease Sleep Scale 2nd version (PDSS-2) consists of 15 questions about various sleep and nocturnal disturbances which are to be rated by the patients using one of five categories, from 0 (never) to 4 (very often). Patients were asked to rate the severity of each question based on their experience during the past week (7 days) from 0 (Never) to 4 (Very often, that meant 6 to 7 days a week). PDSS-2 total score ranges from 0 (no disturbance) to 60 (maximum nocturnal disturbance).

Secondary Outcomes

Nocturnal Hypokinesia Questionnaire (NHQ) Score (Change From Baseline)(Baseline and Week 18)
Scale for Outcomes in Parkinson's Disease (SCOPA)-Sleep Score (Change From Baseline)(Baseline and Week 18)
Early Morning Off (EMO) Score (Change From Baseline)(Baseline and Week 18)
Responder Rate for Parkinson's Disease Sleep Scale 2nd Version (PDSS-2) Total Score<18(At Week 18)
The Parkinson's Disease Questionnaire (PDQ)-8 Score (Change From Baseline)(Baseline and Week 18)
Responder Rate for Early Morning Off (EMO) Score(At Week 18)
Responder Rate for Clinical Global Impression of Improvement (CGI-I)(At Week 18)
Epworth Sleepiness Scale (ESS) Score (Change From Baseline)(Baseline and Week 18)
Responder Rate for Patient Global Impression of Improvement (PGI-I)(At Week 18)