Status:
TERMINATED
Sleep Efficiency Assessed by Polysomnography (PSG Sleep Lab Testing) in Advanced Parkinson's Disease
Lead Sponsor:
UCB Pharma SA
Conditions:
Advanced Idiopathic Parkinson's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 i...
Eligibility Criteria
Inclusion
- Advanced Parkinson's disease (ie, takes Levodopa (L-DOPA))
- Hoehn and Yahr stage score of 2 to 4
- Subject has sleep-maintenance insomnia
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01519882
Start Date
March 1 2012
End Date
January 1 2013
Last Update
April 3 2025
Active Locations (1)
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1
Middlesbrough, United Kingdom