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

This study has been terminated.
(Due to major recruitment issues, a decision was made to terminate this trial)
Sponsor:
Information provided by (Responsible Party):
UCB, Inc. ( UCB Pharma SA )
ClinicalTrials.gov Identifier:
NCT01519882
First received: January 24, 2012
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Advanced Idiopathic Parkinson's Disease
Other: Placebo
Other: Rotigotine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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").


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]

    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.



Enrollment: 1
Study Start Date: March 2012
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo Transdermal Patches
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.

Experimental: Rotigotine
Rotigotine Transdermal Patches
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01519882

Locations
United Kingdom
1
Middlesborough, United Kingdom
Sponsors and Collaborators
UCB Pharma SA
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
No publications provided

Responsible Party: UCB, Inc. ( UCB Pharma SA )
ClinicalTrials.gov Identifier: NCT01519882     History of Changes
Other Study ID Numbers: SP0919, 2011-000056-42
Study First Received: January 24, 2012
Results First Received: December 10, 2013
Last Updated: January 29, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by UCB, Inc.:
Rotigotine
Neupro
Polysomnography
Sleep efficiency
Advanced Idiopathic Parkinson's Disease
Sleep Disorder

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
N 0437
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 29, 2014