- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01519882
Sleep Efficiency Assessed by Polysomnography (PSG Sleep Lab Testing) in Advanced Parkinson's Disease (REFRESH-PD)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Middlesborough, United Kingdom
- 1
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Placebo Transdermal Patches
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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. |
Experimental: Rotigotine
Rotigotine Transdermal Patches
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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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").
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From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in the Parkinson's Disease Sleep Scale Score Version 2 (PDSS2) to Day 1 of the Maintenance Period
Time Frame: From Baseline to Day 1 of the Maintenance Period (up to 7 weeks post-baseline)
|
The PDSS is a scale to assess sleep and nocturnal disability in Parkinson's Disease during the previous 7 days, and is designed for self-completion by the subject. The updated version (PDSS2) contains 15 questions to be answered using a 5-point Likert scale, where 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, and 4 = very often. Thus, PDSS2 score ranges from 0-60, with higher scores indicating worse sleep and higher nocturnal disability. A negative value in Change from Baseline indicates improved sleep and less nocturnal disability. |
From Baseline to Day 1 of the Maintenance Period (up to 7 weeks post-baseline)
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Change From Baseline in the Parkinson's Disease Sleep Scale Score Version 2 (PDSS2) 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 PDSS2 is a scale to assess sleep and nocturnal disability in Parkinson's Disease during the previous 7 days, and is designed for self-completion by the subject. The updated version (PDSS2) contains 15 questions to be answered using a 5-point Likert scale, where 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, and 4 = very often. Thus, PDSS2 score ranges from 0-60, with higher scores indicating worse sleep and higher nocturnal disability. A negative value in Change from Baseline indicates improved sleep and less nocturnal disability. |
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
Time Frame: From Baseline to Day 1 of the Maintenance Period (up to 7 weeks post-baseline)
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The ESS measures the subject's general level of daytime sleepiness. The 8 items of this scale assess the probability of falling asleep in a variety of situations. Each item is scored by the subject using the following categories: 0 = would never doze, 1 = slight chance of dozing, 2 = moderate chance of dozing, and 4 = high chance of dozing. The ESS score ranges from 0 to 32, with higher values indicating a higher level of daytime sleepiness. A negative value in Change from Baseline indicates a decrease in daytime sleepiness. |
From Baseline to Day 1 of the Maintenance Period (up to 7 weeks post-baseline)
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Change From Baseline in the Epworth Sleepiness Score (ESS) 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 ESS measures the subject's general level of daytime sleepiness. The 8 items of this scale assess the probability of falling asleep in a variety of situations. Each item is scored by the subject using the following categories: 0 = would never doze, 1 = slight chance of dozing, 2 = moderate chance of dozing, and 4 = high chance of dozing. The ESS score ranges from 0 to 32, with higher values indicating a higher level of daytime sleepiness. A negative value in Change from Baseline indicates a decrease in daytime sleepiness. |
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
Time Frame: From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)
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Polysomnography (PSG) was performed for the 2 consecutive nights prior to Day 1 and the 2 consecutive nights prior Week 4 of the Maintenance Period. Readings from the first night of the PSG will not be used for analysis as this is considered an adaptation night. The subject was not allowed to sleep during the daytime on the day of a PSG reading. The PSG was recorded for a minimum of 6 h and a maximum of 8 h. The sleep period time in stage 3 non-REM was derived from the hypnogram, based on Electroencephalogram (EEG), Electro-myogram (EMG), Electro-oculogram (EOG) and Electrocardiogram (ECG). Change from Baseline is calculated by: (Stage 3 non-REM time (in minutes) at Baseline)- (Stage 3 non-REM time (in minutes) at Week 4 of the MP). |
From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)
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Change From Baseline in the Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS) to Day 1 of the Maintenance Period
Time Frame: From Baseline to Day 1 of the Maintenance Period (up to 7 weeks post-baseline)
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The NADCS assesses nocturnal akinesia, dystonia, and cramps using an ordinal severity scale.
While a score of 0 = normal and 4 = maximal severity, subjects can also rate their symptoms with values of 0.5, 1.5, 2.5, and 3.5.
The nocturnal akinesia score was used to evaluate motor performance while the dystonia and cramps score was used to evaluate pain.
A negative value in Change from Baseline indicates an improvement.
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From Baseline to Day 1 of the Maintenance Period (up to 7 weeks post-baseline)
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Change From Baseline in the Nocturnal Akinesia, Dystonia and Cramps Score (NADCS) 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 NADCS assesses nocturnal akinesia, dystonia, and cramps using an ordinal severity scale.
While a score of 0 = normal and 4 = maximal severity, subjects can also rate their symptoms with values of 0.5, 1.5, 2.5, and 3.5.
The nocturnal akinesia score was used to evaluate motor performance while the dystonia and cramps score was used to evaluate pain.
A negative value in Change from Baseline indicates an improvement.
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From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)
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Change From Baseline in the Total Wake Time After Sleep Onset (WASO) to Week 4 of the Maintenance Period
Time Frame: From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)
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Polysomnography (PSG) was performed for the 2 consecutive nights prior to Day 1 and the 2 consecutive nights prior Week 4 of the Maintenance Period. Readings from the first night of the PSG will not be used for analysis as this is considered an adaptation night. The subject was not allowed to sleep during the daytime on the day of a PSG reading. The PSG was recorded for a minimum of 6 h and a maximum of 8 h. Sleep stages and time spent in each sleep stage were determined from EEG readings. WASO was calculated by: (Time in bed (Period between "lights off" and "lights on"))-(Sleep time). |
From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)
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Change From Baseline in the Total Number of Turnings in Bed to Week 4 of the Maintenance Period
Time Frame: From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)
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Polysomnography (PSG) was performed for the 2 consecutive nights prior to Day 1 and the 2 consecutive nights prior Week 4 of the Maintenance Period. Readings from the first night of the PSG will not be used for analysis as this is considered an adaptation night. The subject was not allowed to sleep during the daytime on the day of a PSG reading. The PSG was recorded for a minimum of 6 h and a maximum of 8 h. The number of turnings in bed was determined via a postural sensor placed on the subject's chest. |
From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Parkinson Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Dopamine Agonists
- Dopamine Agents
- Rotigotine
Other Study ID Numbers
- SP0919
- 2011-000056-42 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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