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Trial record 1 of 1 for:    NCT01455012
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Effects of Neupro on Cardiovascular Observations in Patients With Restless Legs Syndrome (ENCORE)

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ClinicalTrials.gov Identifier: NCT01455012
Recruitment Status : Completed
First Posted : October 19, 2011
Results First Posted : July 18, 2013
Last Update Posted : July 26, 2013
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES GmbH )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Restless Legs Syndrome
Interventions Drug: Rotigotine
Drug: Placebo
Enrollment 81
Recruitment Details This study started to enroll subjects in September 2011 in order to end up with 9 German centers with enrolled subjects.
Pre-assignment Details Participant Flow refers to the Randomized Set (RS). RS consists of all subjects randomized into this study.
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description

Placebo

Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.

Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)

Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.

Period Title: Overall Study
Started 41 40
Completed 30 36
Not Completed 11 4
Reason Not Completed
Adverse Event             0             2
Lack of Efficacy             6             1
Withdrawal by Subject             3             1
Unknown reason             2             0
Arm/Group Title Placebo Rotigotine Total
Hide Arm/Group Description

Placebo

Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.

Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)

Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.

Total of all reporting groups
Overall Number of Baseline Participants 29 37 66
Hide Baseline Analysis Population Description
Baseline Characteristics refer to the Full Analysis Set (FAS). FAS includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 37 participants 66 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
23
  79.3%
26
  70.3%
49
  74.2%
>=65 years
6
  20.7%
11
  29.7%
17
  25.8%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 37 participants 66 participants
56.0  (9.6) 57.9  (10.2) 57.0  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 37 participants 66 participants
Female
18
  62.1%
22
  59.5%
40
  60.6%
Male
11
  37.9%
15
  40.5%
26
  39.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 29 participants 37 participants 66 participants
29 37 66
1.Primary Outcome
Title Change From Baseline in the Number of Elevations of Systolic Blood Pressure (BP) During the Night That Are Associated With Periodic Limb Movements (PLMs) at the End of the 4-week Maintenance Period
Hide Description

Polysomnography (PSG) recordings, including the assessment of continuous Blood Pressure and 12-lead Electrocardiogram (ECG), were obtained on 2 consecutive nights prior to Baseline Visit and prior to End of Maintenance Period (Visit 7) for up to 8 hours per night. Readings from the first night of the PSG were only used for analysis if the PSG from the second night was determined to be not valid for evaluation. Influence of Periodic Limb Movements (PLMs) on sleep is reflected in the Periodic Limb Movement-Related Arousal Index (PLMAI). Arousal is defined as sudden change in the EEG activity and the index illustrates to what degree the PLMs contribute to arousal from sleep. Sleep stages and time spent in each sleep stage were determined from Electroencephalogram (EEG) readings.

A negative value in Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.

Time Frame Baseline to the end of the 4-week Maintenance Period
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo

Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.

Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)

Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.

Overall Number of Participants Analyzed 29 37
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Nocturnal Elevations of Systolic BP
-79.61
(-119.25 to -39.97)
-239.95
(-275.34 to -204.56)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Rotigotine
Comments The 95 % Confidence Interval (CI) and the p-value for the mean difference between Rotigotine and Placebo was obtained from a linear Analysis of Covariance (ANCOVA) model with fixed effects for treatment and Baseline antihypertensive use and a covariate for the Baseline number of nocturnal elevations of Systolic Blood Pressure that are associated with Periodic Limb Movements (PLMs).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The analysis of this primary efficacy variable was performed using a two-sided alpha level of 5 %.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -160.34
Confidence Interval (2-Sided) 95%
-213.23 to -107.45
Parameter Dispersion
Type: Standard Error of the mean
Value: 26.46
Estimation Comments The treatment effect was estimated on the basis of the Least Square Mean (LSM) of the difference as well as on the 95 % Confidence Interval and the p-value for that difference. Difference to Placebo was calculated as Rotigotine-Placebo.
2.Secondary Outcome
Title Change From Baseline in the Total Number of Elevations of Systolic Blood Pressure (BP) During the Night at the End of the 4-week Maintenance Period
Hide Description

Polysomnography (PSG) recordings, including the assessment of continuous Blood Pressure and 12-lead Electrocardiogram (ECG), were obtained on 2 consecutive nights prior to Baseline Visit and prior to End of Maintenance Period (Visit 7) for up to 8 hours per night. Readings from the first night of the PSG were only used for analysis if the PSG from the second night was determined to be not valid for evaluation. Influence of Periodic Limb Movements (PLMs) on sleep is reflected in the Periodic Limb Movement-Related Arousal Index (PLMAI). Arousal is defined as sudden change in the EEG activity and the index illustrates to what degree the PLMs contribute to arousal from sleep. Sleep stages and time spent in each sleep stage were determined from Electroencephalogram (EEG) readings.

A negative value in Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.

Time Frame Baseline to the end of the 4-week Maintenance Period
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo

Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.

Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)

Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.

Overall Number of Participants Analyzed 29 37
Mean (Standard Deviation)
Unit of Measure: Nocturnal Elevations of Systolic BP
-34.3  (243.4) -199.8  (262.8)
3.Secondary Outcome
Title Change From Baseline in the Periodic Limb Movements Index (PLMI) at the End of the 4-week Maintenance Period
Hide Description 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 PLMI Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Time Frame Baseline to the end of the 4-week Maintenance Period
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo

Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.

Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)

Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.

Overall Number of Participants Analyzed 29 37
Mean (Standard Deviation)
Unit of Measure: Periodic Limb Movements/hour
-15.2  (50.3) -50.1  (44.5)
4.Secondary Outcome
Title Change From Baseline in the International Restless Legs Syndrome Rating Scale (IRLS) at the End of the 4-week Maintenance Period
Hide Description 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' daytime functioning. 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 was calculated. A negative value in IRLS Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Time Frame Baseline to the end of the 4-week Maintenance Period
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo

Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.

Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)

Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.

Overall Number of Participants Analyzed 29 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
-12.5  (9.0) -18.5  (8.0)
5.Secondary Outcome
Title Change From Baseline in Restless Legs Syndrome-Quality of Life (RLS-QoL) at the End of the 4-week Maintenance Period
Hide Description The RLS-QoL is a disease-specific instrument for the evaluation of Quality of life. It consists of 12 items and the overall sum score is calculated from all 12 items and measured on a scale that ranges from 0 (lowest Quality of life) to 60 (highest level of Quality of life). A negative value in RLS-QoL Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Time Frame Baseline to the end of the 4-week Maintenance Period
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo

Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.

Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)

Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.

Overall Number of Participants Analyzed 29 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
-11.0  (11.9) -17.8  (13.2)
6.Secondary Outcome
Title Clinical Global Impressions (CGI) Item 2 (Change of Condition) at the End of the 4-week Maintenance Period
Hide Description

The CGI Item 2 score measures any change in severity of RLS from Baseline on a 7-point scale consisting of the following categories:

  • 1- Very much improved
  • 2- Much improved
  • 3- Minimally improved
  • 4- No change
  • 5- Minimally worse
  • 6- Much worse
  • 7- Very much worse
Time Frame At the end of the 4-week Maintenance Period
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo

Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.

Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)

Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.

Overall Number of Participants Analyzed 29 37
Measure Type: Number
Unit of Measure: participants
Very much improved 9 26
Much improved 9 7
Minimally improved 4 3
No change 6 1
Minimally worse 1 0
Much worse 0 0
Very much worse 0 0
7.Secondary Outcome
Title Clinical Global Impressions (CGI) Item 1 (Severity of Illness) at the End of the 4-week Maintenance Period
Hide Description

The CGI Item 1 score measures the severity of illness on a 7-point scale consisting of the following categories:

  • 1- Normal, not ill at all
  • 2- Borderline ill
  • 3- Mildly ill
  • 4- Moderately ill
  • 5- Markedly ill
  • 6- Severely ill
  • 7- Among the most extremely ill subjects
Time Frame At the end of the 4-week Maintenance Period
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo

Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.

Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)

Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.

Overall Number of Participants Analyzed 29 37
Measure Type: Number
Unit of Measure: participants
Normal, not ill at all 2 6
Borderline ill 8 18
Mildly ill 7 9
Moderately ill 8 2
Markedly ill 3 2
Severely ill 1 0
Among the most extremely ill subjects 0 0
8.Secondary Outcome
Title Clinical Global Impressions (CGI) Item 3 (Therapeutic Efficacy) at the End of the 4-week Maintenance Period
Hide Description

The CGI Item 3 score measures the therapeutic efficacy on a 4-point scale consisting of the following categories:

  • 1- Very good
  • 2- Moderate
  • 3- Slight
  • 4- Unchanged or worse
Time Frame At the end of the 4-week Maintenance Period
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo

Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.

Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)

Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.

Overall Number of Participants Analyzed 29 37
Measure Type: Number
Unit of Measure: participants
Very good 11 31
Moderate 10 4
Slight 3 1
Unchanged or worse 5 1
9.Secondary Outcome
Title Change From Baseline in Restless Legs Syndrome-6 Rating Scales (RLS-6) Item 1 at the End of the 4-week Maintenance Period
Hide Description The RLS-6 consists of 6 items of which four items are designed to assess severity of RLS and two items cover sleep and daytime tiredness. Item 1 measures subject's satisfaction with sleep on a 11-point scale that ranges between 0 (completely satisfied) to 10 (completely dissatisfied). The ratings are given by the subjects. A negative value in RLS-6 Item 6 Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Time Frame Baseline to the end of the 4-week Maintenance Period
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo

Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.

Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)

Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.

Overall Number of Participants Analyzed 29 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.4  (3.1) -4.1  (3.3)
10.Secondary Outcome
Title Change From Baseline in Restless Legs Syndrome-6 Rating Scales (RLS-6) Item 2 at the End of the 4-week Maintenance Period
Hide Description The RLS-6 consists of 6 items of which four items are designed to assess severity of RLS and two items cover sleep and daytime tiredness. Item 2 measures the severity of RLS at time falling asleep on a 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects. A negative value in RLS-6 Item 2 Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Time Frame Baseline to the end of the 4-week Maintenance Period
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo

Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.

Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)

Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.

Overall Number of Participants Analyzed 29 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.9  (3.3) -4.6  (3.8)
11.Secondary Outcome
Title Change From Baseline in Restless Legs Syndrome-6 Rating Scales (RLS-6) Item 3 at the End of the 4-week Maintenance Period
Hide Description The RLS-6 consists of 6 items of which four items are designed to assess severity of RLS and two items cover sleep and daytime tiredness. Item 3 measures the severity of RLS during the night on a 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects. A negative value in RLS-6 Item 3 Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Time Frame Baseline to the end of the 4-week Maintenance Period
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo

Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.

Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)

Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.

Overall Number of Participants Analyzed 29 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.7  (3.5) -4.9  (3.3)
12.Secondary Outcome
Title Change From Baseline in Restless Legs Syndrome-6 Rating Scales (RLS-6) Item 4 at the End of the 4-week Maintenance Period
Hide Description The RLS-6 consists of 6 items of which four items are designed to assess severity of RLS and two items cover sleep and daytime tiredness. Item 4 measures the severity of RLS during day rest on a 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects. A negative value in RLS-6 Item 4 Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Time Frame Baseline to the end of the 4-week Maintenance Period
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo

Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.

Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)

Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.

Overall Number of Participants Analyzed 29 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.7  (3.4) -2.9  (2.9)
13.Secondary Outcome
Title Change From Baseline in Restless Legs Syndrome-6 Rating Scales (RLS-6) Item 5 at the End of the 4-week Maintenance Period
Hide Description The RLS-6 consists of 6 items of which four items are designed to assess severity of RLS and two items cover sleep and daytime tiredness. Item 5 measures the severity of RLS during day not rest on a 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects. A negative value in RLS-6 Item 5 Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Time Frame Baseline to the end of the 4-week Maintenance Period
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo

Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.

Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)

Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.

Overall Number of Participants Analyzed 29 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.3  (1.9) -1.3  (2.6)
14.Secondary Outcome
Title Change From Baseline in Restless Legs Syndrome-6 Rating Scales (RLS-6) Item 6 at the End of the 4-week Maintenance Period
Hide Description The RLS-6 consists of 6 items of which four items are designed to assess severity of RLS and two items cover sleep and daytime tiredness. Item 6 measures subject's tiredness or sleepiness during the day on a 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 RLS-6 Item 6 Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Time Frame Baseline to the end of the 4-week Maintenance Period
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Hide Analysis Population Description
Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo

Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.

Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)

Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.

Overall Number of Participants Analyzed 29 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.5  (2.8) -3.5  (2.8)
Time Frame Adverse Events were collected up to 16 weeks from Screening Period to the Safety Follow-Up Visit.
Adverse Event Reporting Description Adverse Events refer to the Safety Set consisting of all randomized subjects who received at least one dose of study medication.
 
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description

Placebo

Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.

Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)

Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.

All-Cause Mortality
Placebo Rotigotine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Placebo Rotigotine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/40 (0.00%)      0/40 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Rotigotine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/40 (47.50%)      23/40 (57.50%)    
Gastrointestinal disorders     
Nausea * 1  3/40 (7.50%)  3 9/40 (22.50%)  11
Diarrhoea * 1  3/40 (7.50%)  3 0/40 (0.00%)  0
General disorders     
Fatigue * 1  6/40 (15.00%)  6 5/40 (12.50%)  5
Application site pruritus * 1  0/40 (0.00%)  0 2/40 (5.00%)  2
Infections and infestations     
Nasopharyngitis * 1  3/40 (7.50%)  5 7/40 (17.50%)  8
Influenza * 1  2/40 (5.00%)  2 0/40 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  2/40 (5.00%)  2 1/40 (2.50%)  1
Nervous system disorders     
Headache * 1  7/40 (17.50%)  8 7/40 (17.50%)  8
Somnolence * 1  4/40 (10.00%)  4 4/40 (10.00%)  4
Dizziness * 1  1/40 (2.50%)  1 4/40 (10.00%)  4
Psychiatric disorders     
Restlessness * 1  0/40 (0.00%)  0 2/40 (5.00%)  2
Skin and subcutaneous tissue disorders     
Pruritus * 1  1/40 (2.50%)  1 4/40 (10.00%)  4
Erythema * 1  0/40 (0.00%)  0 2/40 (5.00%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
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Name/Title: UCB Clinical Trial Call Center
Organization: UCB
Phone: +1 877 822 9493 (UCB)
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Responsible Party: UCB Pharma ( UCB BIOSCIENCES GmbH )
ClinicalTrials.gov Identifier: NCT01455012    
Other Study ID Numbers: SP0977
2011-000053-23 ( EudraCT Number )
First Submitted: October 10, 2011
First Posted: October 19, 2011
Results First Submitted: May 14, 2013
Results First Posted: July 18, 2013
Last Update Posted: July 26, 2013