| Trial ID: | L1428 |
| Source ID: | NCT01537042
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| Associated Drug: |
Rotigotine
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| Title: |
A Sleep Laboratory Study to Investigate the Safety and Efficacy of the Rotigotine Skin Patch in Subjects With Restless Legs Syndrome and End-Stage Renal Disease Requiring Hemodialysis
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
YES
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| Results: |
https://ClinicalTrials.gov/show/NCT01537042/results
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| Conditions: |
Restless Legs Syndrome|End-Stage Renal Disease
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| Interventions: |
DRUG: Rotigotine|DRUG: Placebo
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| Outcome Measures: |
Primary: Ratio From Baseline to the End of the 2-week Maintenance Period in Periodic Limb Movement Index (PLMI), The PLMI is defined as Periodic Limb Movements (PLMs)/ total time in bed in hours. PLMs are measured by Polysomnography (PSG). The reduction of the PLMI is reflected in terms of the ratio from Baseline to the end of the Maintenance Period and was calculated as \[PLMI at end of Maintenance Period (MP)\] / \[PLMI at Baseline\]. A PLMI Ratio \<1 indicates an improvement from Baseline to the end of the 2-week MP., From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period | Secondary: Change From Baseline in the Periodic Limb Movements Index (PLMI) to the End of the Maintenance Period, The PLMI is defined as Periodic Limb Movements (PLMs)/ total time in bed in hours. PLMs are measured by Polysomnography (PSG). A negative value in change from Baseline indicates an improvement from Baseline to the end of the Maintenance Period., From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Change From Baseline in the International Restless Legs Syndrome Study Group Rating Scale (IRLS) Sum Score to the End of the Maintenance Period, The IRLS is a subject based scale that consists of 10 items to evaluate the severity of major RLS symptoms and the impact of the disease on subjects' functioning in daytime activities. Each of the 10 items is measured on a scale that ranges from 0 (not present) to 4 (severe). A sum score between 0 (no RLS symptoms present at all) and 40 (maximum severity in all symptoms) across all 10 items will be calculated. A negative value in Change from Baseline indicates an improvement from Baseline in IRLS., From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Change From Baseline in Clinical Global Impressions (CGI) Item 1 Score, The CGI Item 1 score measures the severity of illness on a scale that ranges from 0 (Not assessed) to 7 (Among the most extremely ill)., Visit 2 (Baseline); Visit 6 (End of Maintence Period)|Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 1 to the End of the Maintenance Period, The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness. Scale 1 measures satisfaction with sleep during the last seven nights on an 11-point scale that ranges between 0 (completely satisfied) to 10 (completely dissatisfied). The ratings are given by the subjects. A negative value in Change from Baseline indicates an improvement from Baseline., From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 2 to the End of the Maintenance Period, The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness. Scale 2 measures the severity of RLS symptoms during the last 7 nights in the situation of falling asleep. This is measured on an 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects. A negative value in Change from Baseline indicates an improvement from Baseline., From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 3 to the End of the Maintenance Period, The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness. Scale 3 measures the severity of RLS symptoms during the last seven nights on an 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects. A negative value in Change from Baseline indicates an improvement from Baseline., From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 4 to the End of the Maintenance Period, The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness. Scale 4 measures the severity of RLS symptoms during the last seven days at rest on an 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects. A negative value in Change from Baseline indicates an improvement from Baseline., From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 5 to the End of the Maintenance Period, The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness. Scale 5 measures the severity of RLS symptoms during the last seven days engaged in activities on an 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects. A negative value in Change from Baseline indicates an improvement from Baseline., From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 6 to the End of the Maintenance Period, The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness. Scale 6 measures the severity of daytime tiredness/ sleepiness on an 11-point scale that ranges between 0 (not at all) to 10 (very severe). The ratings are given by the subjects. A negative value in Change from Baseline indicates an improvement from Baseline., From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Change From Baseline in the Periodic Limb Movement During Sleep Arousal Index (PLMSAI) to the End of the Maintenance Period, The Periodic Limb Movement during Sleep Arousal Index (PLMSAI) reflects the influence of the PLM on subject's sleep. Arousal is defined as sudden change in the Electroencephalogram (EEG) activity and the index illustrates to what degree the PLMs contribute to arousal from sleep. A negative value in Change from Baseline indicates an improvement from Baseline., From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Change From Baseline in Sleep Efficiency to the End of the Maintenance Period, Sleep stages and time spent in each sleep stage are determined from Electroencephalogram (EEG) readings. Sleep stage data will be used to calculate sleep efficiency. Sleep efficiency will be presented as percentages. Sleep efficiency is the percentage of time in bed spent asleep. A postive value in Change from Baseline indicates an improvement from Baseline., From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Change From Baseline in the Restless Legs-Quality of Life (RLS-QoL) Total Score to the End of the Maintenance Period, The RLS-QoL is a disease-specific questionnaire to evaluate quality of life. It consists of 12 items. A total score will be calculated from all of the 12 items. The overall sum score can be from 0 (highest QoL) to 60 (lowest QoL). A negative value in Change from Baseline indicates an improvement from Baseline., From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Change From Baseline in the Short-Form-36 (SF-36) Item Questionnaire Mental Component Summary (MCS) to the End of the Maintenance Period, The SF-36 is a 36 item generic human research quality of life instrument that uses a recall period of 4 weeks. Items are grouped into 8 domains as follows: Physical Functioning (10 items), Role Physical (4 items), Bodily Pain (2 items), General Health (5 items), Vitality (4 items), Social Functioning (2 items), Role Emotional (3 items), Mental Health (5 items), and a further unscaled single item (question 2) for perceived stability or change in health (Health Transition) during the last year. The norm based scores (based on the US general population) were used for analysis. For the MCS, the lowest and highest possible scores are -9 and 82 (rounded). The SF-36 domains (subscores) are scored so that a higher score indicates a better health state., From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Change From Baseline in the Short-Form-36 (SF-36) Item Questionnaire Physical Component Summary (PCS) to the End of the Maintenance Period, The SF-36 is a 36 item generic human research quality of life instrument that uses a recall period of 4 weeks. Items are grouped into 8 domains as follows: Physical Functioning (10 items), Role Physical (4 items), Bodily Pain (2 items), General Health (5 items), Vitality (4 items), Social Functioning (2 items), Role Emotional (3 items), Mental Health (5 items), and a further unscaled single item (question 2) for perceived stability or change in health (Health Transition) during the last year. The norm-based scores (based on the US general population) were used for analysis. For the PCS, the lowest and highest possible scores are 1 and 81 (rounded). The SF-36 domains (subscores) are scored so that a higher score indicates a better health state., From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
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| Sponsor/Collaborators: |
Sponsor: UCB BIOSCIENCES GmbH
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE3
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| Enrollment: |
30
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
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| Start Date: |
2012-04
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| Completion Date: |
2013-10
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| Results First Posted: |
2014-11-02
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| Last Update Posted: |
2014-11-02
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| Locations: |
606, Brandon, Florida, United States|604, Newton, Massachusetts, United States|603, West Seneca, New York, United States|607, Dublin, Ohio, United States|605, West Chester, Pennsylvania, United States|601, Austin, Texas, United States|101, Innsbruck, Austria|201, Helsinki, Finland|203, Tampere, Finland|302, Bordeaux Cedex, France|301, Montpellier Cédex 5, France|404, Berlin, Germany|401, Marburg, Germany|402, Schwerin, Germany|502, Pisa, Italy
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| URL: |
https://clinicaltrials.gov/show/NCT01537042
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