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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003486-15 | EudraCT Number |
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This is a sleep laboratory study to evaluate the efficacy and safety of Rotigotine in subjects with Restless Legs Syndrome and End-Stage Renal Disease requiring hemodialysis.
The objectives are to demonstrate superiority of Rotigotine against Placebo as well as to investigate the effect of Rotigotine on quality of life and sleep.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rotigotine | Experimental | Rotigotine Transdermal Patch 1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h. |
|
| Placebo | Placebo Comparator | Transdermal patch matched according to patch size and appearance. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotigotine | Drug | Transdermal patch; Dose: 1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h. Subjects start with a Rotigotine dose of 1 mg/24 h for 1 week. The dose can be increased weekly during Up-Titration Period until either the optimal or the maximal dose of 3 mg/24 h has been reached. Subjects will maintain the optimal/maximal dose during the 2-week Maintenance Period. Following the Maintenance Period, subjects will be de-escalated from their optimal dose by decreasing the dose by 1 mg/24 h every other day during Taper Period until complete withdrawal. |
| Measure | Description | Time Frame |
|---|---|---|
| Ratio From Baseline to the End of the 2-week Maintenance Period in Periodic Limb Movement Index (PLMI) | The PLMI is defined as Periodic Limb Movements (PLMs)/ total time in bed in hours. PLMs are measured by Polysomnography (PSG). The reduction of the PLMI is reflected in terms of the ratio from Baseline to the end of the Maintenance Period and was calculated as [PLMI at end of Maintenance Period (MP)] / [PLMI at Baseline]. A PLMI Ratio <1 indicates an improvement from Baseline to the end of the 2-week MP. | From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Periodic Limb Movements Index (PLMI) to the End of the Maintenance Period | The PLMI is defined as Periodic Limb Movements (PLMs)/ total time in bed in hours. PLMs are measured by Polysomnography (PSG). A negative value in change from Baseline indicates an improvement from Baseline to the end of the Maintenance Period. | From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 606 | Brandon | Florida | United States | |||
| 604 |
The participant flow consists of the Randomized Set (RS), which is all subjects randomized into SP0934.
The recruitment for the SP0934 study began in April 2012. It concluded in October 2013. This was a multicenter study with subjects enrolled by 9 sites across Europe and 6 sites across the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Transdermal patch matched according to patch size and appearance. Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance. Up to 3 weeks of Titration, 2 weeks of Maintenance, Up to 4 days of Taper Period. |
| FG001 | Rotigotine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
|
| Placebo | Drug | Transdermal patch; Patches matching to active treatment patches in size and appearance. Up to 3 weeks of Titration, 2 weeks of Maintenance, Up to 4 days of Taper Period. |
|
| Change From Baseline in the International Restless Legs Syndrome Study Group Rating Scale (IRLS) Sum Score to the End of the Maintenance Period | The IRLS is a subject based scale that consists of 10 items to evaluate the severity of major RLS symptoms and the impact of the disease on subjects' functioning in daytime activities. Each of the 10 items is measured on a scale that ranges from 0 (not present) to 4 (severe). A sum score between 0 (no RLS symptoms present at all) and 40 (maximum severity in all symptoms) across all 10 items will be calculated. A negative value in Change from Baseline indicates an improvement from Baseline in IRLS. | From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period |
| Change From Baseline in Clinical Global Impressions (CGI) Item 1 Score | The CGI Item 1 score measures the severity of illness on a scale that ranges from 0 (Not assessed) to 7 (Among the most extremely ill). | Visit 2 (Baseline); Visit 6 (End of Maintence Period) |
| Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 1 to the End of the Maintenance Period | The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness. Scale 1 measures satisfaction with sleep during the last seven nights on an 11-point scale that ranges between 0 (completely satisfied) to 10 (completely dissatisfied). The ratings are given by the subjects. A negative value in Change from Baseline indicates an improvement from Baseline. | From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period |
| Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 2 to the End of the Maintenance Period | The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness. Scale 2 measures the severity of RLS symptoms during the last 7 nights in the situation of falling asleep. This is measured on an 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects. A negative value in Change from Baseline indicates an improvement from Baseline. | From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period |
| Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 3 to the End of the Maintenance Period | The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness. Scale 3 measures the severity of RLS symptoms during the last seven nights on an 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects. A negative value in Change from Baseline indicates an improvement from Baseline. | From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period |
| Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 4 to the End of the Maintenance Period | The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness. Scale 4 measures the severity of RLS symptoms during the last seven days at rest on an 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects. A negative value in Change from Baseline indicates an improvement from Baseline. | From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period |
| Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 5 to the End of the Maintenance Period | The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness. Scale 5 measures the severity of RLS symptoms during the last seven days engaged in activities on an 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects. A negative value in Change from Baseline indicates an improvement from Baseline. | From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period |
| Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 6 to the End of the Maintenance Period | The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness. Scale 6 measures the severity of daytime tiredness/ sleepiness on an 11-point scale that ranges between 0 (not at all) to 10 (very severe). The ratings are given by the subjects. A negative value in Change from Baseline indicates an improvement from Baseline. | From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period |
| Change From Baseline in the Periodic Limb Movement During Sleep Arousal Index (PLMSAI) to the End of the Maintenance Period | The Periodic Limb Movement during Sleep Arousal Index (PLMSAI) reflects the influence of the PLM on subject's sleep. Arousal is defined as sudden change in the Electroencephalogram (EEG) activity and the index illustrates to what degree the PLMs contribute to arousal from sleep. A negative value in Change from Baseline indicates an improvement from Baseline. | From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period |
| Change From Baseline in Sleep Efficiency to the End of the Maintenance Period | Sleep stages and time spent in each sleep stage are determined from Electroencephalogram (EEG) readings. Sleep stage data will be used to calculate sleep efficiency. Sleep efficiency will be presented as percentages. Sleep efficiency is the percentage of time in bed spent asleep. A postive value in Change from Baseline indicates an improvement from Baseline. | From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period |
| Change From Baseline in the Restless Legs-Quality of Life (RLS-QoL) Total Score to the End of the Maintenance Period | The RLS-QoL is a disease-specific questionnaire to evaluate quality of life. It consists of 12 items. A total score will be calculated from all of the 12 items. The overall sum score can be from 0 (highest QoL) to 60 (lowest QoL). A negative value in Change from Baseline indicates an improvement from Baseline. | From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period |
| Change From Baseline in the Short-Form-36 (SF-36) Item Questionnaire Mental Component Summary (MCS) to the End of the Maintenance Period | The SF-36 is a 36 item generic human research quality of life instrument that uses a recall period of 4 weeks. Items are grouped into 8 domains as follows: Physical Functioning (10 items), Role Physical (4 items), Bodily Pain (2 items), General Health (5 items), Vitality (4 items), Social Functioning (2 items), Role Emotional (3 items), Mental Health (5 items), and a further unscaled single item (question 2) for perceived stability or change in health (Health Transition) during the last year. The norm based scores (based on the US general population) were used for analysis. For the MCS, the lowest and highest possible scores are -9 and 82 (rounded). The SF-36 domains (subscores) are scored so that a higher score indicates a better health state. | From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period |
| Change From Baseline in the Short-Form-36 (SF-36) Item Questionnaire Physical Component Summary (PCS) to the End of the Maintenance Period | The SF-36 is a 36 item generic human research quality of life instrument that uses a recall period of 4 weeks. Items are grouped into 8 domains as follows: Physical Functioning (10 items), Role Physical (4 items), Bodily Pain (2 items), General Health (5 items), Vitality (4 items), Social Functioning (2 items), Role Emotional (3 items), Mental Health (5 items), and a further unscaled single item (question 2) for perceived stability or change in health (Health Transition) during the last year. The norm-based scores (based on the US general population) were used for analysis. For the PCS, the lowest and highest possible scores are 1 and 81 (rounded). The SF-36 domains (subscores) are scored so that a higher score indicates a better health state. | From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period |
| Newton |
| Massachusetts |
| United States |
| 603 | West Seneca | New York | United States |
| 607 | Dublin | Ohio | United States |
| 605 | West Chester | Pennsylvania | United States |
| 601 | Austin | Texas | United States |
| 101 | Innsbruck | Austria |
| 201 | Helsinki | Finland |
| 203 | Tampere | Finland |
| 302 | Bordeaux | France |
| 301 | Montpellier Cédex 5 | France |
| 404 | Berlin | Germany |
| 401 | Marburg | Germany |
| 402 | Schwerin | Germany |
| 502 | Pisa | Italy |
Rotigotine Transdermal Patch 1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h. Subjects start with a Rotigotine dose of 1 mg/24 h for 1 week. The dose can be increased weekly during Up-Titration Period until either the optimal or the maximal dose of 3 mg/24 h has been reached. Subjects will maintain the optimal/maximal dose during the 2-week Maintenance Period. Following the Maintenance Period, subjects will be de-escalated from their optimal dose by decreasing the dose by 1 mg/24 h every other day during Taper Period until complete withdrawal. |
| COMPLETED |
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| NOT COMPLETED |
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The baseline analysis population consisted of the Safety Set (SS), which is all subjects who were randomized and had at least 1 patch applied during the Treatment Period.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Transdermal patch matched according to patch size and appearance. Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance. |
| BG001 | Rotigotine | Rotigotine Transdermal Patch 1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Weight | Mean | Standard Deviation | Kilograms |
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| Height | Mean | Standard Deviation | Centimeters |
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| BMI | Mean | Standard Deviation | kg/ m^2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ratio From Baseline to the End of the 2-week Maintenance Period in Periodic Limb Movement Index (PLMI) | The PLMI is defined as Periodic Limb Movements (PLMs)/ total time in bed in hours. PLMs are measured by Polysomnography (PSG). The reduction of the PLMI is reflected in terms of the ratio from Baseline to the end of the Maintenance Period and was calculated as [PLMI at end of Maintenance Period (MP)] / [PLMI at Baseline]. A PLMI Ratio <1 indicates an improvement from Baseline to the end of the 2-week MP. | Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period. | Posted | Least Squares Mean | 95% Confidence Interval | ratio | From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period |
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| Secondary | Change From Baseline in the Periodic Limb Movements Index (PLMI) to the End of the Maintenance Period | The PLMI is defined as Periodic Limb Movements (PLMs)/ total time in bed in hours. PLMs are measured by Polysomnography (PSG). A negative value in change from Baseline indicates an improvement from Baseline to the end of the Maintenance Period. | Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period. | Posted | Mean | Standard Deviation | movement/ hour | From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period |
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| Secondary | Change From Baseline in the International Restless Legs Syndrome Study Group Rating Scale (IRLS) Sum Score to the End of the Maintenance Period | The IRLS is a subject based scale that consists of 10 items to evaluate the severity of major RLS symptoms and the impact of the disease on subjects' functioning in daytime activities. Each of the 10 items is measured on a scale that ranges from 0 (not present) to 4 (severe). A sum score between 0 (no RLS symptoms present at all) and 40 (maximum severity in all symptoms) across all 10 items will be calculated. A negative value in Change from Baseline indicates an improvement from Baseline in IRLS. | Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period. | Posted | Mean | Standard Deviation | units on a scale | From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period |
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| Secondary | Change From Baseline in Clinical Global Impressions (CGI) Item 1 Score | The CGI Item 1 score measures the severity of illness on a scale that ranges from 0 (Not assessed) to 7 (Among the most extremely ill). | Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period. | Posted | Number | participants | Visit 2 (Baseline); Visit 6 (End of Maintence Period) |
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| Secondary | Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 1 to the End of the Maintenance Period | The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness. Scale 1 measures satisfaction with sleep during the last seven nights on an 11-point scale that ranges between 0 (completely satisfied) to 10 (completely dissatisfied). The ratings are given by the subjects. A negative value in Change from Baseline indicates an improvement from Baseline. | Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period. | Posted | Mean | Standard Deviation | units on a scale | From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period |
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| Secondary | Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 2 to the End of the Maintenance Period | The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness. Scale 2 measures the severity of RLS symptoms during the last 7 nights in the situation of falling asleep. This is measured on an 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects. A negative value in Change from Baseline indicates an improvement from Baseline. | Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period. | Posted | Mean | Standard Deviation | units on a scale | From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period |
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| Secondary | Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 3 to the End of the Maintenance Period | The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness. Scale 3 measures the severity of RLS symptoms during the last seven nights on an 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects. A negative value in Change from Baseline indicates an improvement from Baseline. | Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period. | Posted | Mean | Standard Deviation | units on a scale | From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period |
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| Secondary | Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 4 to the End of the Maintenance Period | The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness. Scale 4 measures the severity of RLS symptoms during the last seven days at rest on an 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects. A negative value in Change from Baseline indicates an improvement from Baseline. | Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period. | Posted | Mean | Standard Deviation | units on a scale | From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period |
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| Secondary | Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 5 to the End of the Maintenance Period | The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness. Scale 5 measures the severity of RLS symptoms during the last seven days engaged in activities on an 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects. A negative value in Change from Baseline indicates an improvement from Baseline. | Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period. | Posted | Mean | Standard Deviation | units on a scale | From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period |
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| Secondary | Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 6 to the End of the Maintenance Period | The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness. Scale 6 measures the severity of daytime tiredness/ sleepiness on an 11-point scale that ranges between 0 (not at all) to 10 (very severe). The ratings are given by the subjects. A negative value in Change from Baseline indicates an improvement from Baseline. | Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period. | Posted | Mean | Standard Deviation | units on a scale | From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period |
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| Secondary | Change From Baseline in the Periodic Limb Movement During Sleep Arousal Index (PLMSAI) to the End of the Maintenance Period | The Periodic Limb Movement during Sleep Arousal Index (PLMSAI) reflects the influence of the PLM on subject's sleep. Arousal is defined as sudden change in the Electroencephalogram (EEG) activity and the index illustrates to what degree the PLMs contribute to arousal from sleep. A negative value in Change from Baseline indicates an improvement from Baseline. | Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period. | Posted | Mean | Standard Deviation | movement per hour | From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period |
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| Secondary | Change From Baseline in Sleep Efficiency to the End of the Maintenance Period | Sleep stages and time spent in each sleep stage are determined from Electroencephalogram (EEG) readings. Sleep stage data will be used to calculate sleep efficiency. Sleep efficiency will be presented as percentages. Sleep efficiency is the percentage of time in bed spent asleep. A postive value in Change from Baseline indicates an improvement from Baseline. | Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period. | Posted | Mean | Standard Deviation | sleep time/ total time in bed | From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period |
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| Secondary | Change From Baseline in the Restless Legs-Quality of Life (RLS-QoL) Total Score to the End of the Maintenance Period | The RLS-QoL is a disease-specific questionnaire to evaluate quality of life. It consists of 12 items. A total score will be calculated from all of the 12 items. The overall sum score can be from 0 (highest QoL) to 60 (lowest QoL). A negative value in Change from Baseline indicates an improvement from Baseline. | Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period. | Posted | Mean | Standard Deviation | scores on a scale | From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period |
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| Secondary | Change From Baseline in the Short-Form-36 (SF-36) Item Questionnaire Mental Component Summary (MCS) to the End of the Maintenance Period | The SF-36 is a 36 item generic human research quality of life instrument that uses a recall period of 4 weeks. Items are grouped into 8 domains as follows: Physical Functioning (10 items), Role Physical (4 items), Bodily Pain (2 items), General Health (5 items), Vitality (4 items), Social Functioning (2 items), Role Emotional (3 items), Mental Health (5 items), and a further unscaled single item (question 2) for perceived stability or change in health (Health Transition) during the last year. The norm based scores (based on the US general population) were used for analysis. For the MCS, the lowest and highest possible scores are -9 and 82 (rounded). The SF-36 domains (subscores) are scored so that a higher score indicates a better health state. | Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period. | Posted | Mean | Standard Deviation | units on a scale | From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period |
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| Secondary | Change From Baseline in the Short-Form-36 (SF-36) Item Questionnaire Physical Component Summary (PCS) to the End of the Maintenance Period | The SF-36 is a 36 item generic human research quality of life instrument that uses a recall period of 4 weeks. Items are grouped into 8 domains as follows: Physical Functioning (10 items), Role Physical (4 items), Bodily Pain (2 items), General Health (5 items), Vitality (4 items), Social Functioning (2 items), Role Emotional (3 items), Mental Health (5 items), and a further unscaled single item (question 2) for perceived stability or change in health (Health Transition) during the last year. The norm-based scores (based on the US general population) were used for analysis. For the PCS, the lowest and highest possible scores are 1 and 81 (rounded). The SF-36 domains (subscores) are scored so that a higher score indicates a better health state. | Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period. | Posted | Mean | Standard Deviation | units on a scale | From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period |
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Adverse Events were recorded during the course of the SP0934 study, which began in April 2012 and concluded in October 2013.
Adverse Events reporting refers to the Safety Set (SS). All subjects who are randomized and have at least 1 patch applied during the Treatment Period were included in the SS.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Transdermal patch matched according to patch size and appearance. Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance. | 1 | 10 | 4 | 10 | ||
| EG001 | Rotigotine | Rotigotine Transdermal Patch 1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h. | 3 | 20 | 12 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (16.1) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye haemorrhage | Eye disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Application site pruritus | General disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Dialysis device complication | Injury, poisoning and procedural complications | MedDRA (16.1) | Non-systematic Assessment |
| |
| Back injury | Injury, poisoning and procedural complications | MedDRA (16.1) | Non-systematic Assessment |
| |
| Electrocardiogram PR prolongation | Investigations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Electrocardiogram ST segment abnormal | Investigations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Dysphoria | Psychiatric disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (16.1) | Non-systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | UCB Clinical Trial Call Center | +1 887 822 9493 |
| ID | Term |
|---|---|
| D012148 | Restless Legs Syndrome |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D020447 | Parasomnias |
| D001523 | Mental Disorders |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C047508 | rotigotine |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Europe |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Rotigotine (Visit 6) |
Rotigotine Transdermal Patch 1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h. |
|
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| Units | Counts |
|---|
| Participants |
|
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| Units | Counts |
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| Participants |
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| Units |
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| Counts |
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| Participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
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| Units | Counts |
|---|
| Participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
|
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| Units |
|---|
| Counts |
|---|
| Participants |
|
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| Participants |
|
|
| Participants |
|
|
Rotigotine Transdermal Patch
1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h.
|
|
Rotigotine Transdermal Patch
1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h.
|
|