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Trial record 1 of 1 for:    NCT01569464
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Rotigotine Effect on All-day Functioning and Quality of Life in Subjects With Moderate to Severe Restless Legs Syndrome (RLS) (RESTORE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01569464
Recruitment Status : Completed
First Posted : April 3, 2012
Results First Posted : August 26, 2014
Last Update Posted : August 26, 2014
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

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
Other: Placebo
Enrollment 150
Recruitment Details The recruitment for the RL0003 study began in March 2012. It concluded in April 2013. Recruitment for this study took place in the United States of America.
Pre-assignment Details

The participant flow consists of the Randomized Set (RS), which is all subjects randomized into the study.

The demographics and study outcomes consist of the Full Analysis Set (FAS), which includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables.

Arm/Group Title Rotigotine Placebo
Hide Arm/Group Description

Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg / 24 hr or until effective or maximum dose was reached.

Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:

Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours

7 weeks (titration plus maintenance)

Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.

Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours

7 weeks

Period Title: Overall Study
Started 101 49
Completed 91 44
Not Completed 10 5
Reason Not Completed
Adverse Event             4             0
Lack of Efficacy             1             0
Protocol Violation             1             0
Lost to Follow-up             2             3
Withdrawal by Subject             1             1
Other             1             1
Arm/Group Title Rotigotine Placebo Total
Hide Arm/Group Description

Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.

Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:

Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours

7 weeks (titration plus maintenance)

Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.

Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours

7 weeks

Total of all reporting groups
Overall Number of Baseline Participants 101 49 150
Hide Baseline Analysis Population Description
The demographics section consists of the Full Analysis Set (FAS), which includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants 49 participants 150 participants
<=18 years
2
   2.0%
0
   0.0%
2
   1.3%
Between 18 and 65 years
89
  88.1%
44
  89.8%
133
  88.7%
>=65 years
10
   9.9%
5
  10.2%
15
  10.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 101 participants 49 participants 150 participants
47.9  (14.2) 47.9  (13.7) 47.9  (14.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants 49 participants 150 participants
Female
58
  57.4%
20
  40.8%
78
  52.0%
Male
43
  42.6%
29
  59.2%
72
  48.0%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 101 participants 49 participants 150 participants
80.93  (15.11) 80.18  (12.94) 80.69  (14.40)
1.Primary Outcome
Title Change From Baseline To The End Of The Maintenance Period in International Restless Legs Scale (IRLS) Sum Score
Hide Description

The International Restless Legs Scale (IRLS) was intended to evaluate, in a standardized way, the subjective intensity of major symptoms of Restless Legs Syndrome (RLS) and, in 2 items (9 and 10), the impact of the disease on subjects functioning in daytime activities by use of a 5-point scale for each of a total of 10 items.

In all items, the scores ranged from 0 (not present) to 4 (severe). A sum score across all 10 items was calculated for analysis, which varied between 0 (no RLS symptoms present at all) to 40 (maximum severity in all symptoms).

Time Frame Baseline to End of Maintenance Period (approximately 7 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description

Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).

Out of the 150 patients in the FAS, 150 were included in this analysis.

The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables.

Arm/Group Title Rotigotine Placebo
Hide Arm/Group Description:

Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.

Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:

Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours

7 weeks (titration plus maintenance)

Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.

Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours

7 weeks

Overall Number of Participants Analyzed 101 49
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-15.46  (1.00) -15.19  (1.29)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rotigotine, Placebo
Comments ANCOVA model was used for analysis with fixed effects for treatment assignment (main factor) and the subject's investigational center (stratifying factor) and a covariate for the Baseline Visit value of the IRLS sum score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8451
Comments A hierarchical test procedure was done for the primary efficacy variables at an α-level of 5 %. If a test was statistically significant, a test for the next variable was performed. If a test was not statistically significant the procedure stopped.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.27
Confidence Interval (2-Sided) 95%
-2.96 to 2.42
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.36
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change In Average Of Means Of Multiple Suggested Immobilization Test Discomfort Scale (m-SIT-DS) Values Of Each Individual Suggested Immobilization Test (SIT) For The Combination Of Multiple Suggested Immobilization Test (m SIT)
Hide Description

The Multiple Suggested Immobilization Test Discomfort Scale (m-SIT-DS) was used for assessment of the sensory components of Restless Legs Syndrome (RLS) symptoms in order to provide a subjective score of the severity of RLS symptoms during each Suggested Immobilization Test (SIT).

Scores ranged from 0 (no symptoms) to 10 (very severe symptoms) and were assessed every 10 minutes within each SIT.

Time Frame Baseline to End of Maintenance Period (approximately 7 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description

Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).

Out of the 150 patients in the FAS, 150 were included in this analysis.

The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables.

Arm/Group Title Rotigotine Placebo
Hide Arm/Group Description:

Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.

Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:

Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours

7 weeks (titration plus maintenance)

Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.

Placebo 1 mg/ 24 hr, Placebo 2 mg/r24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours

7 weeks

Overall Number of Participants Analyzed 101 49
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.83  (0.25) -2.90  (0.33)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rotigotine, Placebo
Comments ANCOVA model was used for analysis with fixed effects for treatment assignment (main factor) and the subject's investigational center (stratifying factor) and a covariate for the Baseline Visit value of the IRLS sum score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8336
Comments A hierarchical test procedure was done for the primary efficacy variables at an α-level of 5 %. If a test was statistically significant, a test for the next variable was performed. If a test was not statistically significant the procedure stopped.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.07
Confidence Interval (2-Sided) 95%
-0.61 to 0.75
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.34
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change In Average Of Means Of Periodic Limb Movement During Wakefulness Index (PLMWI) Change In Average Of Means Of Periodic Limb Movement During Wakefulness Index (PLMWI) For The Combination Of Multiple Suggested Immobilization Test (m-SIT)
Hide Description

During each single Suggested Immobilization Test (SIT) PLMWI was measured using a validated actigraphy device. Simultaneous actigraphy of the legs was performed by an actigraphy device, which was attached to the ankle prior to the start of the SIT. The PLMWI was recorded while the subject was awake.

Scores ranged from 0 (no symptoms) to 10 (very severe symptoms) and were assessed every 10 minutes within each SIT.

Time Frame Baseline to End of Maintenance Period (approximately 7 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description

Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).

Out of the 150 patients in the FAS, 149 were included in this analysis.

The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables.

Arm/Group Title Rotigotine Placebo
Hide Arm/Group Description:

Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.

Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:

Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours

7 weeks (titration plus maintenance)

Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.

Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours

7 weeks

Overall Number of Participants Analyzed 101 48
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-48.05  (6.25) -56.39  (8.03)
4.Secondary Outcome
Title Change In Item Score From Baseline To The End Of The Maintenance Period In Satisfaction With Sleep (Item 1 of Restless Legs Syndrome 6 Rating Scales [RLS-6])
Hide Description The RLS-6 is an 11-point scale. This 11-point scale was provided with ranges between (0 = completely satisfied) to (10 = completely dissatisfied).
Time Frame Baseline to End of Maintenance Period (approximately 7 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description

Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).

Out of the 150 patients in the FAS, 150 were included in this analysis.

The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables.

Arm/Group Title Rotigotine Placebo
Hide Arm/Group Description:

Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.

Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:

Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours

7 weeks (titration plus maintenance)

Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.

Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours

7 weeks

Overall Number of Participants Analyzed 101 49
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-3.44  (0.40) -3.93  (0.51)
5.Secondary Outcome
Title Change In Item Score From Baseline To The End Of The Maintenance Period In Severity Of Restless Legs Syndrome (RLS) At Bedtime (Item 2 of Restless Legs Syndrome 6 Rating Scales [RLS-6])
Hide Description The RLS-6 is an 11-point scale. This 11-point scale was provided with ranges between (0 = none) to (10 = very severe).
Time Frame Baseline to End of Maintenance Period (approximately 7 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description

Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).

Out of the 150 patients in the FAS, 150 were included in this analysis.

The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables.

Arm/Group Title Rotigotine Placebo
Hide Arm/Group Description:

Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.

Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:

Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours

7 weeks (titration plus maintenance)

Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.

Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours

7 weeks

Overall Number of Participants Analyzed 101 49
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-4.62  (0.31) -4.46  (0.40)
6.Secondary Outcome
Title Change In Item Score From Baseline To The End Of The Maintenance Period In Severity Of Restless Legs Syndrome (RLS) During The Night (Item 3 of Restless Legs Syndrome 6 Rating Scales [RLS-6])
Hide Description The RLS-6 is an 11-point scale. This 11-point scale was provided with ranges between (0 = none) to (10 = very severe).
Time Frame Baseline to End of Maintenance Period (approximately 7 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description

Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).

Out of the 150 patients in the FAS, 150 were included in this analysis.

The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables.

Arm/Group Title Rotigotine Placebo
Hide Arm/Group Description:

Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.

Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:

Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours

7 weeks (titration plus maintenance)

Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.

Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours

7 weeks

Overall Number of Participants Analyzed 101 49
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-4.46  (0.29) -4.45  (0.38)
7.Secondary Outcome
Title Change In Item Score From Baseline To The End Of The Maintenance Period In Severity Of Restless Legs Syndrome (RLS) At Daytime At Rest (Item 4 of Restless Legs Syndrome 6 Rating Scales [RLS-6])
Hide Description The RLS-6 is an 11-point scale. This 11-point scale was provided with ranges between (0 = none) to (10 = very severe).
Time Frame Baseline to End of Maintenance Period (approximately 7 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description

Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).

Out of the 150 patients in the FAS, 150 were included in this analysis.

The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables.

Arm/Group Title Rotigotine Placebo
Hide Arm/Group Description:

Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.

Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:

Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours

7 weeks (titration plus maintenance)

Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.

Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours

7 weeks

Overall Number of Participants Analyzed 101 49
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-3.44  (0.27) -2.94  (0.35)
8.Secondary Outcome
Title Change In Item Score From Baseline To The End Of The Maintenance Period In Severity of Restless Legs Syndrome (RLS) At Daytime In Activity (Item 5 of Restless Legs Syndrome 6 Rating Scales [RLS-6])
Hide Description The RLS-6 is an 11-point scale. This 11-point scale was provided with ranges between (0 = none) to (10 = very severe).
Time Frame Baseline to End of Maintenance Period (approximately 7 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description

Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).

Out of the 150 patients in the FAS, 150 were included in this analysis.

The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables.

Arm/Group Title Rotigotine Placebo
Hide Arm/Group Description:

Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.

Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:

Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours

7 weeks (titration plus maintenance)

Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.

Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours

7 weeks

Overall Number of Participants Analyzed 101 49
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.80  (0.21) -1.69  (0.27)
9.Secondary Outcome
Title Change In Item Score From Baseline To The End Of The Maintenance Period In Daytime Tiredness (Item 6 of Restless Legs Syndrome 6 Rating Scales [RLS-6])
Hide Description The RLS-6 is an 11-point scale. This 11-point scale was provided with ranges between (0 = not at all) to (10 = very severe).
Time Frame Baseline to End of Maintenance Period (approximately 7 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description

Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).

Out of the 150 patients in the FAS, 150 were included in this analysis.

The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables.

Arm/Group Title Rotigotine Placebo
Hide Arm/Group Description:

Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.

Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:

Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours

7 weeks (titration plus maintenance)

Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.

Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours

7 weeks

Overall Number of Participants Analyzed 101 49
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-3.02  (0.31) -3.09  (0.40)
10.Secondary Outcome
Title Change From Baseline To The End Of Maintenance Period In Daytime Somnolence Domain Score Of The Medical Outcomes Study (MOS) Sleep Scale - Revised (MOS Sleep-R)
Hide Description

The Medical Outcomes Study (MOS) Sleep Scale-Revised (MOS Sleep-R) is a self-administered questionnaire measuring several important aspects of sleep that have been validated in both general and patient populations.

The MOS Sleep-R consists of 12-items. Responses for 10 of the 12 items are on a 5-point frequency scale with options ranging from "all of the time" to "none of the time". The other two items ask about the length of time to fall asleep and the average number of hours slept per night. The sleep problems index I allows for the summary of sleep problems using an abbreviated six-item index, whereas the sleep problems index II uses nine of the 12 items of the scale to compute an overall sleep problem summary. A higher score on each scale in summary index represents a lack of sleep problems (better sleep quality). All scores are transformed linearly to range from 0 to 100, with the exception of the sleep quantity subscale, which is scored in hours.

Time Frame Baseline to End of Maintenance Period (approximately 7 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description

Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).

Out of the 150 patients in the FAS, 150 were included in this analysis.

The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables.

Arm/Group Title Rotigotine Placebo
Hide Arm/Group Description:

Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.

Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:

Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours

7 weeks (titration plus maintenance)

Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.

Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours

7 weeks

Overall Number of Participants Analyzed 101 49
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
15.28  (2.30) 14.05  (2.95)
11.Secondary Outcome
Title Change From Baseline To The End of Maintenance Period In Sleep Disturbance Domain Score Of The Medical Outcomes Study (MOS) Sleep Scale - Revised (MOS Sleep-R)
Hide Description

The Medical Outcomes Study (MOS) Sleep Scale-Revised (MOS Sleep-R) is a self-administered questionnaire measuring several important aspects of sleep that have been validated in both general and patient populations.

The MOS Sleep-R consists of 12-items. Responses for 10 of the 12 items are on a 5-point frequency scale with options ranging from "all of the time" to "none of the time". The other two items ask about the length of time to fall asleep and the average number of hours slept per night. The sleep problems index I allows for the summary of sleep problems using an abbreviated six-item index, whereas the sleep problems index II uses nine of the 12 items of the scale to compute an overall sleep problem summary. A higher score on each scale in summary index represents a lack of sleep problems (better sleep quality). All scores are transformed linearly to range from 0 to 100, with the exception of the sleep quantity subscale, which is scored in hours.

Time Frame Baseline to End of Maintenance Period (approximately 7 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description

Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).

Out of the 150 patients in the FAS, 150 were included in this analysis.

The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables.

Arm/Group Title Rotigotine Placebo
Hide Arm/Group Description:

Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.

Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:

Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours

7 weeks (titration plus maintenance)

Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.

Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours

7 weeks

Overall Number of Participants Analyzed 101 49
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
30.29  (2.82) 29.10  (3.60)
12.Secondary Outcome
Title Change From Baseline To The End of Maintenance Period In Sleep Adequacy Domain Score Of The Medical Outcomes Study (MOS) Sleep Scale - Revised (MOS Sleep-R)
Hide Description

The Medical Outcomes Study (MOS) Sleep Scale-Revised (MOS Sleep-R) is a self-administered questionnaire measuring several important aspects of sleep that have been validated in both general and patient populations.

The MOS Sleep-R consists of 12-items. Responses for 10 of the 12 items are on a 5-point frequency scale with options ranging from "all of the time" to "none of the time". The other two items ask about the length of time to fall asleep and the average number of hours slept per night. The sleep problems index I allows for the summary of sleep problems using an abbreviated six-item index, whereas the sleep problems index II uses nine of the 12 items of the scale to compute an overall sleep problem summary. A higher score on each scale in summary index represents a lack of sleep problems (better sleep quality). All scores are transformed linearly to range from 0 to 100, with the exception of the sleep quantity subscale, which is scored in hours.

Time Frame Baseline to End of Maintenance Period (approximately 7 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description

Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).

Out of the 150 patients in the FAS, 150 were included in this analysis.

The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables.

Arm/Group Title Rotigotine Placebo
Hide Arm/Group Description:

Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.

Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:

Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours

7 weeks (titration plus maintenance)

Placebo patches titrated from 1 mg/ 24 hr - 3 mg/r24 hr or until effective or maximum dose was reached.

Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours

7 weeks

Overall Number of Participants Analyzed 101 49
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
23.40  (3.09) 22.88  (3.96)
13.Secondary Outcome
Title Change From Baseline To The End of Maintenance Period In Sleep Quantity Domain Score Of The Medical Outcomes Study (MOS) Sleep Scale - Revised (Sleep Scale-R)
Hide Description

The Medical Outcomes Study (MOS) Sleep Scale-Revised (MOS Sleep-R) is a self-administered questionnaire measuring several important aspects of sleep that have been validated in both general and patient populations.

The MOS Sleep-R consists of 12-items. Responses for 10 of the 12 items are on a 5-point frequency scale with options ranging from "all of the time" to "none of the time". The other two items ask about the length of time to fall asleep and the average number of hours slept per night. The sleep problems index I allows for the summary of sleep problems using an abbreviated six-item index, whereas the sleep problems index II uses nine of the 12 items of the scale to compute an overall sleep problem summary. A higher score on each scale in summary index represents a lack of sleep problems (better sleep quality). All scores are transformed linearly to range from 0 to 100, with the exception of the sleep quantity subscale, which is scored in hours.

Time Frame Baseline to End of Maintenance Period (approximately 7 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description

Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).

Out of the 150 patients in the FAS, 150 were included in this analysis.

The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables.

Arm/Group Title Rotigotine Placebo
Hide Arm/Group Description:

Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.

Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:

Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours

7 weeks (titration plus maintenance)

Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.

Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours

7 weeks

Overall Number of Participants Analyzed 101 49
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.87  (0.17) 1.11  (0.21)
14.Secondary Outcome
Title Change In Total Score From Baseline To The End of Maintenance Period On Profile Of Mood States Questionnaire (POMS)
Hide Description

The Profile of Mood States questionnaire (POMS) total score will be calculated as the sum of the scores for the following 5 scale scores (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Fatigue-Inertia, and Confusion-Bewilderment) and then subtracting the Vigor-Activity score. All factors have to be available for the total score to be calculated; otherwise the total score will be set to missing. The range for the POMS is 0 - 200 with a high score being negative and a low score being positive.

For the POMS questionnaire total score, descriptive statistics will be presented on both the observed and the change from Baseline to the end of the Maintenance Period values for the Full Analysis Set (FAS).

Time Frame Baseline to End of Maintenance Period (approximately 7 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description

Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).

Out of the 150 patients in the FAS, 150 were included in this analysis.

The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables.

Arm/Group Title Rotigotine Placebo
Hide Arm/Group Description:

Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.

Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:

Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours

7 weeks (titration plus maintenance)

Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.

Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours

7 weeks

Overall Number of Participants Analyzed 101 49
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-8.27  (3.01) -9.07  (3.80)
15.Secondary Outcome
Title Change From Baseline in SF-36 Mental Component Summary Score
Hide Description

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.

Time Frame Baseline to End of Maintenance Period (approximately 7 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description

Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).

Out of the 150 patients in the FAS, 150 were included in this analysis.

The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables.

Arm/Group Title Rotigotine Placebo
Hide Arm/Group Description:

Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.

Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:

Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours

7 weeks (titration plus maintenance)

Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.

Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours

7 weeks

Overall Number of Participants Analyzed 101 49
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
1.77  (1.01) 1.79  (1.29)
16.Secondary Outcome
Title Change From Baseline in SF-36 Physical Component Summary Score
Hide Description

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.

Time Frame Baseline to End of Maintenance Period (7 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description

Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).

Out of the 150 patients in the FAS, 150 were included in this analysis.

The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables.

Arm/Group Title Rotigotine Placebo
Hide Arm/Group Description:

Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.

Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:

Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours

7 weeks (titration plus maintenance)

Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.

Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours

7 weeks

Overall Number of Participants Analyzed 101 49
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
2.16  (0.76) 2.28  (0.98)
Time Frame Adverse Events were recorded during the course of the RL0003 study, which began in March 2012 and concluded in April 2013.
Adverse Event Reporting Description Adverse Event reporting consists of the Safety Set (SS). The SS consists of all randomized subjects that received at least 1 dose of study drug.
 
Arm/Group Title Rotigotine Placebo
Hide Arm/Group Description

Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.

Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:

Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours

7 weeks (titration plus maintenance)

Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.

Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours

7 weeks

All-Cause Mortality
Rotigotine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Rotigotine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/101 (1.98%)      0/49 (0.00%)    
Infections and infestations     
Pneumonia * 1  1/101 (0.99%)  1 0/49 (0.00%)  0
Metabolism and nutrition disorders     
Hypokalaemia * 1  1/101 (0.99%)  1 0/49 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rotigotine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   42/101 (41.58%)      21/49 (42.86%)    
Gastrointestinal disorders     
Nausea * 1  16/101 (15.84%)  19 3/49 (6.12%)  3
Vomiting * 1  6/101 (5.94%)  7 1/49 (2.04%)  1
Diarrhoea * 1  4/101 (3.96%)  4 4/49 (8.16%)  4
General disorders     
Application site pruritus * 1  12/101 (11.88%)  15 2/49 (4.08%)  2
Nervous system disorders     
Headache * 1  10/101 (9.90%)  13 5/49 (10.20%)  9
Somnolence * 1  8/101 (7.92%)  9 4/49 (8.16%)  4
Dizziness * 1  8/101 (7.92%)  8 1/49 (2.04%)  1
Restless legs syndrome * 1  1/101 (0.99%)  1 4/49 (8.16%)  5
*
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.
UCB has > 60 but <= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that the results shall be published regardless of outcome.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: UCB Clinical Trial Call Center
Phone: +1 887 822 9493
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01569464    
Other Study ID Numbers: RL0003
First Submitted: March 30, 2012
First Posted: April 3, 2012
Results First Submitted: April 15, 2014
Results First Posted: August 26, 2014
Last Update Posted: August 26, 2014