A Multi-Centre, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Effects of Rotigotine on Sleep Efficiency in Patients With Advanced Parkinson's Disease.

UCB Pharma SA1 site in 1 country1 target enrollmentMarch 2012

ConditionsAdvanced Idiopathic Parkinson's Disease

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Advanced Idiopathic Parkinson's Disease
Sponsor: UCB Pharma SA
Enrollment: 1
Locations: 1
Primary Endpoint: Percentage Change From Baseline in Sleep Efficiency Index (SEI) to Week 4 of the Maintenance Period
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a phase 4 study to evaluate with Polysomnography (PSG) and subjective measures the effect of Rotigotine on sleep efficiency, maintenance, insomnia, nocturnal akinesia and night-time movement in bed, in patients with advanced Parkinson's disease.

Registry

clinicaltrials.gov

Start Date

March 2012

End Date

January 2013

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

UCB Pharma SA

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Advanced Parkinson's disease (ie, takes Levodopa (L-DOPA))
•Hoehn and Yahr stage score of 2 to 4
•Subject has sleep-maintenance insomnia

Exclusion Criteria

•Significant skin disease that would make transdermal drug use inappropriate
•Subject received therapy with controlled-release Levodopa (L-DOPA), entacapone or Stalevo® within 28 days prior to the Baseline Visit or has received therapy with Tolcapone
•Atypical Parkinsonian syndromes
•Previous diagnosis of Narcolepsy, Sleep Apnoea Syndrome, significant Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD), moderate to severe Restless Legs Syndrome (RLS) or Periodic Limb Movement Disorder

Outcomes

Primary Outcomes

Percentage Change From Baseline in Sleep Efficiency Index (SEI) to Week 4 of the Maintenance Period

Time Frame: From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)

The Sleep Efficiency Index in percent is the ratio of total sleep time (based on Polysomnography recordings) to time in bed (period between "lights off" and "lights on").

Secondary Outcomes

Change From Baseline in the Parkinson's Disease Sleep Scale Score Version 2 (PDSS2) to Day 1 of the Maintenance Period(From Baseline to Day 1 of the Maintenance Period (up to 7 weeks post-baseline))
Change From Baseline in the Parkinson's Disease Sleep Scale Score Version 2 (PDSS2) to Week 4 of the Maintenance Period(From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline))
Change From Baseline in the Epworth Sleepiness Score (ESS) to Day 1 of the Maintenance Period(From Baseline to Day 1 of the Maintenance Period (up to 7 weeks post-baseline))
Change From Baseline in the Epworth Sleepiness Score (ESS) to Week 4 of the Maintenance Period(From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline))
Change From Baseline in the Sleep Period Time in Non-Rapid Eye Movement (Non-REM) Sleep to Week 4 of the Maintenance Period(From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline))
Change From Baseline in the Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS) to Day 1 of the Maintenance Period(From Baseline to Day 1 of the Maintenance Period (up to 7 weeks post-baseline))
Change From Baseline in the Nocturnal Akinesia, Dystonia and Cramps Score (NADCS) to Week 4 of the Maintenance Period(From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline))
Change From Baseline in the Total Wake Time After Sleep Onset (WASO) to Week 4 of the Maintenance Period(From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline))
Change From Baseline in the Total Number of Turnings in Bed to Week 4 of the Maintenance Period(From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline))