Trial Outcomes & Findings for Rotigotine Effect on All-day Functioning and Quality of Life in Subjects With Moderate to Severe Restless Legs Syndrome (RLS) (NCT NCT01569464)
NCT ID: NCT01569464
Last Updated: 2014-08-26
Results Overview
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).
COMPLETED
PHASE3
150 participants
Baseline to End of Maintenance Period (approximately 7 weeks)
2014-08-26
Participant Flow
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.
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.
Participant milestones
| Measure |
Rotigotine
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
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 Study
STARTED
|
101
|
49
|
|
Overall Study
COMPLETED
|
91
|
44
|
|
Overall Study
NOT COMPLETED
|
10
|
5
|
Reasons for withdrawal
| Measure |
Rotigotine
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
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 Study
Adverse Event
|
4
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Other
|
1
|
1
|
Baseline Characteristics
Rotigotine Effect on All-day Functioning and Quality of Life in Subjects With Moderate to Severe Restless Legs Syndrome (RLS)
Baseline characteristics by cohort
| Measure |
Rotigotine
n=101 Participants
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
n=49 Participants
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
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
89 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
133 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Age, Continuous
|
47.9 years
STANDARD_DEVIATION 14.2 • n=99 Participants
|
47.9 years
STANDARD_DEVIATION 13.7 • n=107 Participants
|
47.9 years
STANDARD_DEVIATION 14.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
78 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
72 Participants
n=206 Participants
|
|
Weight
|
80.93 Kilograms
STANDARD_DEVIATION 15.11 • n=99 Participants
|
80.18 Kilograms
STANDARD_DEVIATION 12.94 • n=107 Participants
|
80.69 Kilograms
STANDARD_DEVIATION 14.40 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to End of Maintenance Period (approximately 7 weeks)Population: 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.
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).
Outcome measures
| Measure |
Rotigotine
n=101 Participants
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
n=49 Participants
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
|
|---|---|---|
|
Change From Baseline To The End Of The Maintenance Period in International Restless Legs Scale (IRLS) Sum Score
|
-15.46 units on a scale
Standard Error 1.00
|
-15.19 units on a scale
Standard Error 1.29
|
PRIMARY outcome
Timeframe: Baseline to End of Maintenance Period (approximately 7 weeks)Population: 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.
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.
Outcome measures
| Measure |
Rotigotine
n=101 Participants
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
n=49 Participants
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
|
|---|---|---|
|
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)
|
-2.83 units on a scale
Standard Error 0.25
|
-2.90 units on a scale
Standard Error 0.33
|
SECONDARY outcome
Timeframe: Baseline to End of Maintenance Period (approximately 7 weeks)Population: 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.
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.
Outcome measures
| Measure |
Rotigotine
n=101 Participants
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
n=48 Participants
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
|
|---|---|---|
|
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)
|
-48.05 units on a scale
Standard Error 6.25
|
-56.39 units on a scale
Standard Error 8.03
|
SECONDARY outcome
Timeframe: Baseline to End of Maintenance Period (approximately 7 weeks)Population: 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.
The RLS-6 is an 11-point scale. This 11-point scale was provided with ranges between (0 = completely satisfied) to (10 = completely dissatisfied).
Outcome measures
| Measure |
Rotigotine
n=101 Participants
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
n=49 Participants
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
|
|---|---|---|
|
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])
|
-3.44 units on a scale
Standard Error 0.40
|
-3.93 units on a scale
Standard Error 0.51
|
SECONDARY outcome
Timeframe: Baseline to End of Maintenance Period (approximately 7 weeks)Population: 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.
The RLS-6 is an 11-point scale. This 11-point scale was provided with ranges between (0 = none) to (10 = very severe).
Outcome measures
| Measure |
Rotigotine
n=101 Participants
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
n=49 Participants
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
|
|---|---|---|
|
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])
|
-4.62 units on a scale
Standard Error 0.31
|
-4.46 units on a scale
Standard Error 0.40
|
SECONDARY outcome
Timeframe: Baseline to End of Maintenance Period (approximately 7 weeks)Population: 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.
The RLS-6 is an 11-point scale. This 11-point scale was provided with ranges between (0 = none) to (10 = very severe).
Outcome measures
| Measure |
Rotigotine
n=101 Participants
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
n=49 Participants
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
|
|---|---|---|
|
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])
|
-4.46 units on a scale
Standard Error 0.29
|
-4.45 units on a scale
Standard Error 0.38
|
SECONDARY outcome
Timeframe: Baseline to End of Maintenance Period (approximately 7 weeks)Population: 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.
The RLS-6 is an 11-point scale. This 11-point scale was provided with ranges between (0 = none) to (10 = very severe).
Outcome measures
| Measure |
Rotigotine
n=101 Participants
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
n=49 Participants
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
|
|---|---|---|
|
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])
|
-3.44 units on a scale
Standard Error 0.27
|
-2.94 units on a scale
Standard Error 0.35
|
SECONDARY outcome
Timeframe: Baseline to End of Maintenance Period (approximately 7 weeks)Population: 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.
The RLS-6 is an 11-point scale. This 11-point scale was provided with ranges between (0 = none) to (10 = very severe).
Outcome measures
| Measure |
Rotigotine
n=101 Participants
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
n=49 Participants
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
|
|---|---|---|
|
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])
|
-1.80 units on a scale
Standard Error 0.21
|
-1.69 units on a scale
Standard Error 0.27
|
SECONDARY outcome
Timeframe: Baseline to End of Maintenance Period (approximately 7 weeks)Population: 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.
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).
Outcome measures
| Measure |
Rotigotine
n=101 Participants
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
n=49 Participants
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
|
|---|---|---|
|
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])
|
-3.02 units on a scale
Standard Error 0.31
|
-3.09 units on a scale
Standard Error 0.40
|
SECONDARY outcome
Timeframe: Baseline to End of Maintenance Period (approximately 7 weeks)Population: 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.
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.
Outcome measures
| Measure |
Rotigotine
n=101 Participants
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
n=49 Participants
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
|
|---|---|---|
|
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)
|
15.28 units on a scale
Standard Error 2.30
|
14.05 units on a scale
Standard Error 2.95
|
SECONDARY outcome
Timeframe: Baseline to End of Maintenance Period (approximately 7 weeks)Population: 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.
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.
Outcome measures
| Measure |
Rotigotine
n=101 Participants
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
n=49 Participants
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
|
|---|---|---|
|
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)
|
30.29 units on a scale
Standard Error 2.82
|
29.10 units on a scale
Standard Error 3.60
|
SECONDARY outcome
Timeframe: Baseline to End of Maintenance Period (approximately 7 weeks)Population: 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.
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.
Outcome measures
| Measure |
Rotigotine
n=101 Participants
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
n=49 Participants
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
|
|---|---|---|
|
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)
|
23.40 units on a scale
Standard Error 3.09
|
22.88 units on a scale
Standard Error 3.96
|
SECONDARY outcome
Timeframe: Baseline to End of Maintenance Period (approximately 7 weeks)Population: 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.
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.
Outcome measures
| Measure |
Rotigotine
n=101 Participants
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
n=49 Participants
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
|
|---|---|---|
|
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)
|
0.87 units on a scale
Standard Error 0.17
|
1.11 units on a scale
Standard Error 0.21
|
SECONDARY outcome
Timeframe: Baseline to End of Maintenance Period (approximately 7 weeks)Population: 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.
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).
Outcome measures
| Measure |
Rotigotine
n=101 Participants
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
n=49 Participants
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
|
|---|---|---|
|
Change In Total Score From Baseline To The End of Maintenance Period On Profile Of Mood States Questionnaire (POMS)
|
-8.27 units on a scale
Standard Error 3.01
|
-9.07 units on a scale
Standard Error 3.80
|
SECONDARY outcome
Timeframe: Baseline to End of Maintenance Period (approximately 7 weeks)Population: 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.
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.
Outcome measures
| Measure |
Rotigotine
n=101 Participants
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
n=49 Participants
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
|
|---|---|---|
|
Change From Baseline in SF-36 Mental Component Summary Score
|
1.77 units on a scale
Standard Error 1.01
|
1.79 units on a scale
Standard Error 1.29
|
SECONDARY outcome
Timeframe: Baseline to End of Maintenance Period (7 weeks)Population: 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.
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.
Outcome measures
| Measure |
Rotigotine
n=101 Participants
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
n=49 Participants
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
|
|---|---|---|
|
Change From Baseline in SF-36 Physical Component Summary Score
|
2.16 units on a scale
Standard Error 0.76
|
2.28 units on a scale
Standard Error 0.98
|
Adverse Events
Rotigotine
Placebo
Serious adverse events
| Measure |
Rotigotine
n=101 participants at risk
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
n=49 participants at risk
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
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
0.99%
1/101 • Number of events 1 • Adverse Events were recorded during the course of the RL0003 study, which began in March 2012 and concluded in April 2013.
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.
|
0.00%
0/49 • Adverse Events were recorded during the course of the RL0003 study, which began in March 2012 and concluded in April 2013.
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.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.99%
1/101 • Number of events 1 • Adverse Events were recorded during the course of the RL0003 study, which began in March 2012 and concluded in April 2013.
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.
|
0.00%
0/49 • Adverse Events were recorded during the course of the RL0003 study, which began in March 2012 and concluded in April 2013.
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.
|
Other adverse events
| Measure |
Rotigotine
n=101 participants at risk
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
n=49 participants at risk
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
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
15.8%
16/101 • Number of events 19 • Adverse Events were recorded during the course of the RL0003 study, which began in March 2012 and concluded in April 2013.
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.
|
6.1%
3/49 • Number of events 3 • Adverse Events were recorded during the course of the RL0003 study, which began in March 2012 and concluded in April 2013.
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.
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
6/101 • Number of events 7 • Adverse Events were recorded during the course of the RL0003 study, which began in March 2012 and concluded in April 2013.
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.
|
2.0%
1/49 • Number of events 1 • Adverse Events were recorded during the course of the RL0003 study, which began in March 2012 and concluded in April 2013.
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.0%
4/101 • Number of events 4 • Adverse Events were recorded during the course of the RL0003 study, which began in March 2012 and concluded in April 2013.
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.
|
8.2%
4/49 • Number of events 4 • Adverse Events were recorded during the course of the RL0003 study, which began in March 2012 and concluded in April 2013.
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.
|
|
General disorders
Application site pruritus
|
11.9%
12/101 • Number of events 15 • Adverse Events were recorded during the course of the RL0003 study, which began in March 2012 and concluded in April 2013.
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.
|
4.1%
2/49 • Number of events 2 • Adverse Events were recorded during the course of the RL0003 study, which began in March 2012 and concluded in April 2013.
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.
|
|
Nervous system disorders
Headache
|
9.9%
10/101 • Number of events 13 • Adverse Events were recorded during the course of the RL0003 study, which began in March 2012 and concluded in April 2013.
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.
|
10.2%
5/49 • Number of events 9 • Adverse Events were recorded during the course of the RL0003 study, which began in March 2012 and concluded in April 2013.
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.
|
|
Nervous system disorders
Somnolence
|
7.9%
8/101 • Number of events 9 • Adverse Events were recorded during the course of the RL0003 study, which began in March 2012 and concluded in April 2013.
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.
|
8.2%
4/49 • Number of events 4 • Adverse Events were recorded during the course of the RL0003 study, which began in March 2012 and concluded in April 2013.
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.
|
|
Nervous system disorders
Dizziness
|
7.9%
8/101 • Number of events 8 • Adverse Events were recorded during the course of the RL0003 study, which began in March 2012 and concluded in April 2013.
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.
|
2.0%
1/49 • Number of events 1 • Adverse Events were recorded during the course of the RL0003 study, which began in March 2012 and concluded in April 2013.
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.
|
|
Nervous system disorders
Restless legs syndrome
|
0.99%
1/101 • Number of events 1 • Adverse Events were recorded during the course of the RL0003 study, which began in March 2012 and concluded in April 2013.
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.
|
8.2%
4/49 • Number of events 5 • Adverse Events were recorded during the course of the RL0003 study, which began in March 2012 and concluded in April 2013.
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.
|
Additional Information
Study Director
UCB Clinical Trial Call Center
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER