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Sleep Efficiency Assessed by Polysomnography (PSG Sleep Lab Testing) in Advanced Parkinson's Disease (REFRESH-PD)

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: NCT01519882
Recruitment Status : Terminated (Due to major recruitment issues, a decision was made to terminate this trial)
First Posted : January 27, 2012
Results First Posted : January 28, 2014
Last Update Posted : March 3, 2014
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Pharma SA )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Advanced Idiopathic Parkinson's Disease
Interventions Other: Placebo
Other: Rotigotine
Enrollment 1
Recruitment Details The study started in March 2012 and was conducted in the United Kingdom. It was terminated due to recruitment issues in January 2013.
Pre-assignment Details 1 subjects was randomized to Placebo and started and completed the study (from Screening (Week 0) to the Safety Follow-Up Visit (Week 18)).
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description

Placebo Transdermal Patches

Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.

Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day.

Rotigotine Transdermal Patches

Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.

Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day.

Period Title: Overall Study
Started 1 0
Completed 1 0
Not Completed 0 0
Arm/Group Title Placebo Rotigotine Total
Hide Arm/Group Description

Placebo Transdermal Patches

Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.

Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day.

Rotigotine Transdermal Patches

Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.

Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day.

Total of all reporting groups
Overall Number of Baseline Participants 1 0 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 1 participants
<=18 years 0 0
Between 18 and 65 years 0 0
>=65 years 1 1
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1 participants 0 participants 1 participants
67 [1]   (NA) 67 [1]   (NA)
[1]
The mean presented here is the individual age of the only subject included.
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 1 participants
Female 1 1
Male 0 0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 1 participants 0 participants 1 participants
1 1
1.Primary Outcome
Title Percentage Change From Baseline in Sleep Efficiency Index (SEI) to Week 4 of the Maintenance Period
Hide Description The Sleep Efficiency Index in percent is the ratio of total sleep time (based on Polysomnography recordings) to time in bed (period between "lights off" and "lights on").
Time Frame From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo Transdermal Patches

Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.

Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day.

Rotigotine Transdermal Patches

Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.

Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day.

Overall Number of Participants Analyzed 1 0
Mean (Standard Deviation)
Unit of Measure: percentage change
4.7 [1]   (NA)
[1]
The mean presented here is the individual percentage change in SEI (from Baseline to Week 4 of the Maintenance Period) of the only subject included.
2.Secondary Outcome
Title Change From Baseline in the Parkinson’s Disease Sleep Scale Score Version 2 (PDSS2) to Day 1 of the Maintenance Period
Hide Description

The PDSS is a scale to assess sleep and nocturnal disability in Parkinson’s Disease during the previous 7 days, and is designed for self-completion by the subject. The updated version (PDSS2) contains 15 questions to be answered using a 5-point Likert scale, where 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, and 4 = very often.

Thus, PDSS2 score ranges from 0-60, with higher scores indicating worse sleep and higher nocturnal disability. A negative value in Change from Baseline indicates improved sleep and less nocturnal disability.

Time Frame From Baseline to Day 1 of the Maintenance Period (up to 7 weeks post-baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo Transdermal Patches

Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.

Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day.

Rotigotine Transdermal Patches

Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.

Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day.

Overall Number of Participants Analyzed 1 0
Mean (Standard Deviation)
Unit of Measure: units on a scale
3 [1]   (NA)
[1]
The mean presented here is the individual change in PDSS2 (from Baseline to Day 1 of the Maintenance Period) of the only subject included.
3.Secondary Outcome
Title Change From Baseline in the Parkinson's Disease Sleep Scale Score Version 2 (PDSS2) to Week 4 of the Maintenance Period
Hide Description

The PDSS2 is a scale to assess sleep and nocturnal disability in Parkinson’s Disease during the previous 7 days, and is designed for self-completion by the subject. The updated version (PDSS2) contains 15 questions to be answered using a 5-point Likert scale, where 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, and 4 = very often.

Thus, PDSS2 score ranges from 0-60, with higher scores indicating worse sleep and higher nocturnal disability. A negative value in Change from Baseline indicates improved sleep and less nocturnal disability.

Time Frame From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo Transdermal Patches

Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.

Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day.

Rotigotine Transdermal Patches

Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.

Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day.

Overall Number of Participants Analyzed 1 0
Mean (Standard Deviation)
Unit of Measure: units on a scale
6 [1]   (NA)
[1]
The mean presented here is the individual change in PDSS2 (from Baseline to Week 4 of the Maintenance Period) of the only subject included.
4.Secondary Outcome
Title Change From Baseline in the Epworth Sleepiness Score (ESS) to Day 1 of the Maintenance Period
Hide Description

The ESS measures the subject’s general level of daytime sleepiness. The 8 items of this scale assess the probability of falling asleep in a variety of situations. Each item is scored by the subject using the following categories:

0 = would never doze, 1 = slight chance of dozing, 2 = moderate chance of dozing, and 4 = high chance of dozing.

The ESS score ranges from 0 to 32, with higher values indicating a higher level of daytime sleepiness. A negative value in Change from Baseline indicates a decrease in daytime sleepiness.

Time Frame From Baseline to Day 1 of the Maintenance Period (up to 7 weeks post-baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo Transdermal Patches

Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.

Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day.

Rotigotine Transdermal Patches

Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.

Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day.

Overall Number of Participants Analyzed 1 0
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1 [1]   (NA)
[1]
The mean presented here is the individual change in ESS (from Baseline to Day 1 of the Maintenance Period) of the only subject included.
5.Secondary Outcome
Title Change From Baseline in the Epworth Sleepiness Score (ESS) to Week 4 of the Maintenance Period
Hide Description

The ESS measures the subject’s general level of daytime sleepiness. The 8 items of this scale assess the probability of falling asleep in a variety of situations. Each item is scored by the subject using the following categories:

0 = would never doze, 1 = slight chance of dozing, 2 = moderate chance of dozing, and 4 = high chance of dozing.

The ESS score ranges from 0 to 32, with higher values indicating a higher level of daytime sleepiness. A negative value in Change from Baseline indicates a decrease in daytime sleepiness.

Time Frame From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo Transdermal Patches

Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.

Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day.

Rotigotine Transdermal Patches

Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.

Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day.

Overall Number of Participants Analyzed 1 0
Mean (Standard Deviation)
Unit of Measure: units on a scale
0 [1]   (NA)
[1]
The mean presented here is the individual change in ESS (from Baseline to Week 4 of the Maintenance Period) of the only subject included.
6.Secondary Outcome
Title Change From Baseline in the Sleep Period Time in Non-Rapid Eye Movement (Non-REM) Sleep to Week 4 of the Maintenance Period
Hide Description

Polysomnography (PSG) was performed for the 2 consecutive nights prior to Day 1 and the 2 consecutive nights prior Week 4 of the Maintenance Period.

Readings from the first night of the PSG will not be used for analysis as this is considered an adaptation night.

The subject was not allowed to sleep during the daytime on the day of a PSG reading. The PSG was recorded for a minimum of 6 h and a maximum of 8 h.

The sleep period time in stage 3 non-REM was derived from the hypnogram, based on Electroencephalogram (EEG), Electro-myogram (EMG), Electro-oculogram (EOG) and Electrocardiogram (ECG). Change from Baseline is calculated by:

(Stage 3 non-REM time (in minutes) at Baseline)- (Stage 3 non-REM time (in minutes) at Week 4 of the MP).

Time Frame From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo Transdermal Patches

Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.

Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day.

Rotigotine Transdermal Patches

Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.

Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day.

Overall Number of Participants Analyzed 1 0
Mean (Standard Deviation)
Unit of Measure: minutes
22 [1]   (NA)
[1]
The mean presented here is the individual change in sleep Period time in Non-REM sleep (from Baseline to Week 4 of the Maintenance Period) of the only subject included.
7.Secondary Outcome
Title Change From Baseline in the Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS) to Day 1 of the Maintenance Period
Hide Description The NADCS assesses nocturnal akinesia, dystonia, and cramps using an ordinal severity scale. While a score of 0 = normal and 4 = maximal severity, subjects can also rate their symptoms with values of 0.5, 1.5, 2.5, and 3.5. The nocturnal akinesia score was used to evaluate motor performance while the dystonia and cramps score was used to evaluate pain. A negative value in Change from Baseline indicates an improvement.
Time Frame From Baseline to Day 1 of the Maintenance Period (up to 7 weeks post-baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo Transdermal Patches

Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.

Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day.

Rotigotine Transdermal Patches

Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.

Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day.

Overall Number of Participants Analyzed 1 0
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.5 [1]   (NA)
[1]
The mean presented here is the individual change in NADCS (from Baseline to Day 1 of the Maintenance Period) of the only subject included.
8.Secondary Outcome
Title Change From Baseline in the Nocturnal Akinesia, Dystonia and Cramps Score (NADCS) to Week 4 of the Maintenance Period
Hide Description The NADCS assesses nocturnal akinesia, dystonia, and cramps using an ordinal severity scale. While a score of 0 = normal and 4 = maximal severity, subjects can also rate their symptoms with values of 0.5, 1.5, 2.5, and 3.5. The nocturnal akinesia score was used to evaluate motor performance while the dystonia and cramps score was used to evaluate pain. A negative value in Change from Baseline indicates an improvement.
Time Frame From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo Transdermal Patches

Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.

Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day.

Rotigotine Transdermal Patches

Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.

Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day.

Overall Number of Participants Analyzed 1 0
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.5 [1]   (NA)
[1]
The mean presented here is the individual change in NADCS (from Baseline to Week 4 of the Maintenance Period) of the only subject included.
9.Secondary Outcome
Title Change From Baseline in the Total Wake Time After Sleep Onset (WASO) to Week 4 of the Maintenance Period
Hide Description

Polysomnography (PSG) was performed for the 2 consecutive nights prior to Day 1 and the 2 consecutive nights prior Week 4 of the Maintenance Period.

Readings from the first night of the PSG will not be used for analysis as this is considered an adaptation night.

The subject was not allowed to sleep during the daytime on the day of a PSG reading. The PSG was recorded for a minimum of 6 h and a maximum of 8 h.

Sleep stages and time spent in each sleep stage were determined from EEG readings. WASO was calculated by:

(Time in bed (Period between "lights off" and "lights on"))-(Sleep time).

Time Frame From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo Transdermal Patches

Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.

Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day.

Rotigotine Transdermal Patches

Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.

Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day.

Overall Number of Participants Analyzed 1 0
Mean (Standard Deviation)
Unit of Measure: minutes
20 [1]   (NA)
[1]
The mean presented here is the individual change in total Wake Time After Sleep Onset (from Baseline to Week 4 of the Maintenance Period) of the only subject included.
10.Secondary Outcome
Title Change From Baseline in the Total Number of Turnings in Bed to Week 4 of the Maintenance Period
Hide Description

Polysomnography (PSG) was performed for the 2 consecutive nights prior to Day 1 and the 2 consecutive nights prior Week 4 of the Maintenance Period.

Readings from the first night of the PSG will not be used for analysis as this is considered an adaptation night.

The subject was not allowed to sleep during the daytime on the day of a PSG reading. The PSG was recorded for a minimum of 6 h and a maximum of 8 h.

The number of turnings in bed was determined via a postural sensor placed on the subject’s chest.

Time Frame From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo Transdermal Patches

Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.

Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day.

Rotigotine Transdermal Patches

Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.

Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day.

Overall Number of Participants Analyzed 1 0
Measure Type: Number
Unit of Measure: Number of turnings in bed
0
Time Frame Adverse Events were collected from Baseline to the Safety Follow-Up Visit at Week 18.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description

Placebo Transdermal Patches

Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.

Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day.

Rotigotine Transdermal Patches

Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.

Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day.

All-Cause Mortality
Placebo Rotigotine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Rotigotine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Rotigotine
Affected / at Risk (%) Affected / at Risk (%)
Total   1/1 (100.00%)   0/0 
Ear and labyrinth disorders     
Vertigo * 1  1/1 (100.00%)  0/0 
Gastrointestinal disorders     
Constipation * 1  1/1 (100.00%)  0/0 
Infections and infestations     
Rhinitis * 1  1/1 (100.00%)  0/0 
Nervous system disorders     
Lethargy * 1  1/1 (100.00%)  0/0 
Tension Headache * 1  1/1 (100.00%)  0/0 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.1)

Despite many attempts by study sites to recruit subjects, only 1 subject was randomized by Oct 2012. The decision to terminate the study was taken in Nov 2012. The subject completed in Jan 2013.

No planned efficacy/safety analyses were performed.

Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB Clinical Trial Call Center
Organization: UCB
Phone: +1 877 822 9493 (UCB)
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB Pharma SA )
ClinicalTrials.gov Identifier: NCT01519882     History of Changes
Other Study ID Numbers: SP0919
2011-000056-42 ( EudraCT Number )
First Submitted: January 24, 2012
First Posted: January 27, 2012
Results First Submitted: December 10, 2013
Results First Posted: January 28, 2014
Last Update Posted: March 3, 2014