Clinical trial NCT01519882: Sleep Efficiency Assessed by Polysomnography (PSG Sleep Lab Testing) in Advanced Parkinson's Disease
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Advanced Idiopathic Parkinson's Disease
Keywords: Rotigotine
Neupro
Polysomnography
Sleep efficiency
Advanced Idiopathic Parkinson's Disease
Sleep Disorder
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2012-01-27
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage Change From Baseline in Sleep Efficiency Index (SEI) to Week 4 of the Maintenance Period
timeFrame: From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)
Secondary outcomes:
measure: Change From Baseline in the Parkinson's Disease Sleep Scale Score Version 2 (PDSS2) to Day 1 of the Maintenance Period
timeFrame: From Baseline to Day 1 of the Maintenance Period (up to 7 weeks post-baseline)
measure: Change From Baseline in the Parkinson's Disease Sleep Scale Score Version 2 (PDSS2) to Week 4 of the Maintenance Period
timeFrame: From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)
measure: Change From Baseline in the Epworth Sleepiness Score (ESS) to Day 1 of the Maintenance Period
timeFrame: From Baseline to Day 1 of the Maintenance Period (up to 7 weeks post-baseline)
measure: Change From Baseline in the Epworth Sleepiness Score (ESS) to Week 4 of the Maintenance Period
timeFrame: From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)
measure: Change From Baseline in the Sleep Period Time in Non-Rapid Eye Movement (Non-REM) Sleep to Week 4 of the Maintenance Period
timeFrame: From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)
measure: Change From Baseline in the Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS) to Day 1 of the Maintenance Period
timeFrame: From Baseline to Day 1 of the Maintenance Period (up to 7 weeks post-baseline)
measure: Change From Baseline in the Nocturnal Akinesia, Dystonia and Cramps Score (NADCS) to Week 4 of the Maintenance Period
timeFrame: From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)
measure: Change From Baseline in the Total Wake Time After Sleep Onset (WASO) to Week 4 of the Maintenance Period
timeFrame: From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)
measure: Change From Baseline in the Total Number of Turnings in Bed to Week 4 of the Maintenance Period
timeFrame: From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)
Other outcomes:
Locations:
city: Middlesborough
country: United Kingdom
facility: 1
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: