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Trial record 14 of 27 for:    PDSS2

Sleep Efficiency Assessed by Polysomnography (PSG Sleep Lab Testing) in Advanced Parkinson's Disease (REFRESH-PD)

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ClinicalTrials.gov Identifier: NCT01519882
Recruitment Status : Terminated (Due to major recruitment issues, a decision was made to terminate this trial)
First Posted : January 27, 2012
Results First Posted : January 28, 2014
Last Update Posted : March 3, 2014
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Pharma SA )

Tracking Information
First Submitted Date  ICMJE January 24, 2012
First Posted Date  ICMJE January 27, 2012
Results First Submitted Date  ICMJE December 10, 2013
Results First Posted Date  ICMJE January 28, 2014
Last Update Posted Date March 3, 2014
Study Start Date  ICMJE March 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2014)
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").
Original Primary Outcome Measures  ICMJE
 (submitted: January 26, 2012)
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 ]
SEI in percent is the ratio of total sleep time to time in bed.
Change History Complete list of historical versions of study NCT01519882 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2014)
  • 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.
  • 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.
  • 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) ]
    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.
  • 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.
  • 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) ]
    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).
  • 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) ]
    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.
  • 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.
  • 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) ]
    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).
  • 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) ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2012)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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. ]
  • Change from Baseline in the Nocturnal Akinesia, Dystonia, and Cramps Score (NACDS) to Day 1 of the Maintenance Period [ Time Frame: From Baseline to Day 1 of the Maintenance Period ]
  • Change from Baseline in the Nocturnal Akinesia, Dystonia and Cramps Score (NACDS) to Week 4 of the Maintenance Period [ Time Frame: From Baseline to Week 4 of the Maintenance period. ]
  • 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 ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sleep Efficiency Assessed by Polysomnography (PSG Sleep Lab Testing) in Advanced Parkinson's Disease
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Advanced Idiopathic Parkinson's Disease
Intervention  ICMJE
  • Other: 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.

  • Other: 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 Names:
    • Neupro®
    • (6S)-6-propyl-[2-(2-thienyl)ethyl]amino-5,6,7,8-tetrahydro-1-naphthalenol
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo Transdermal Patches
    Intervention: Other: Placebo
  • Experimental: Rotigotine
    Rotigotine Transdermal Patches
    Intervention: Other: Rotigotine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 26, 2012)
1
Original Estimated Enrollment  ICMJE
 (submitted: January 26, 2012)
60
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01519882
Other Study ID Numbers  ICMJE SP0919
2011-000056-42 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma ( UCB Pharma SA )
Study Sponsor  ICMJE UCB Pharma SA
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
PRS Account UCB Pharma
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP