Sleep Efficiency Assessed by Polysomnography (PSG Sleep Lab Testing) in Advanced Parkinson's Disease
NCT ID: NCT01519882
Last Updated: 2025-04-03
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
1 participants
INTERVENTIONAL
2012-03-31
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo Transdermal Patches
Placebo
Placebo patches size equivalent to 4, 6 \& 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.
Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day.
Rotigotine
Rotigotine Transdermal Patches
Rotigotine
Rotigotine patches of 4,6 \& 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.
Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day.
Interventions
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Placebo
Placebo patches size equivalent to 4, 6 \& 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.
Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day.
Rotigotine
Rotigotine patches of 4,6 \& 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.
Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Hoehn and Yahr stage score of 2 to 4
* Subject has sleep-maintenance insomnia
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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UCB Pharma SA
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493 (UCB)
Locations
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1
Middlesbrough, , United Kingdom
Countries
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Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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2011-000056-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SP0919
Identifier Type: -
Identifier Source: org_study_id
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