Trial Outcomes & Findings for Sleep Efficiency Assessed by Polysomnography (PSG Sleep Lab Testing) in Advanced Parkinson's Disease (NCT NCT01519882)

Results Overview

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").

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

1 participants

Primary outcome timeframe

From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)

Results posted on

2025-04-03

Participant Flow

The study started in March 2012 and was conducted in the United Kingdom. It was terminated due to recruitment issues in January 2013.

1 subjects was randomized to Placebo and started and completed the study (from Screening (Week 0) to the Safety Follow-Up Visit (Week 18)).

Participant milestones

Participant milestones
Measure	Placebo 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 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 Study STARTED	1	0
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=1 Participants 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 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 n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Age, Continuous	67 years STANDARD_DEVIATION NA • n=5 Participants	—	67 years STANDARD_DEVIATION NA • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Region of Enrollment United Kingdom	1 participants n=5 Participants	—	1 participants n=5 Participants

PRIMARY outcome

Timeframe: From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)

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").

Outcome measures

Outcome measures
Measure	Placebo n=1 Participants 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 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.
Percentage Change From Baseline in Sleep Efficiency Index (SEI) to Week 4 of the Maintenance Period	4.7 percentage change Standard Deviation NA 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.	—

SECONDARY outcome

Timeframe: From Baseline to Day 1 of the Maintenance Period (up to 7 weeks post-baseline)

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.

Outcome measures

Outcome measures
Measure	Placebo n=1 Participants 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 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.
Change From Baseline in the Parkinson's Disease Sleep Scale Score Version 2 (PDSS2) to Day 1 of the Maintenance Period	3 units on a scale Standard Deviation NA The mean presented here is the individual change in PDSS2 (from Baseline to Day 1 of the Maintenance Period) of the only subject included.	—

SECONDARY outcome

Timeframe: From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)

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.

Outcome measures

Outcome measures
Measure	Placebo n=1 Participants 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 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.
Change From Baseline in the Parkinson's Disease Sleep Scale Score Version 2 (PDSS2) to Week 4 of the Maintenance Period	6 units on a scale Standard Deviation NA The mean presented here is the individual change in PDSS2 (from Baseline to Week 4 of the Maintenance Period) of the only subject included.	—

SECONDARY outcome

Timeframe: From Baseline to Day 1 of the Maintenance Period (up to 7 weeks post-baseline)

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.

Outcome measures

Outcome measures
Measure	Placebo n=1 Participants 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 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.
Change From Baseline in the Epworth Sleepiness Score (ESS) to Day 1 of the Maintenance Period	-1 units on a scale Standard Deviation NA The mean presented here is the individual change in ESS (from Baseline to Day 1 of the Maintenance Period) of the only subject included.	—

SECONDARY outcome

Timeframe: From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)

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.

Outcome measures

Outcome measures
Measure	Placebo n=1 Participants 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 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.
Change From Baseline in the Epworth Sleepiness Score (ESS) to Week 4 of the Maintenance Period	0 units on a scale Standard Deviation NA The mean presented here is the individual change in ESS (from Baseline to Week 4 of the Maintenance Period) of the only subject included.	—

SECONDARY outcome

Timeframe: From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)

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).

Outcome measures

Outcome measures
Measure	Placebo n=1 Participants 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 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.
Change From Baseline in the Sleep Period Time in Non-Rapid Eye Movement (Non-REM) Sleep to Week 4 of the Maintenance Period	22 minutes Standard Deviation NA 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.	—

SECONDARY outcome

Timeframe: From Baseline to Day 1 of the Maintenance Period (up to 7 weeks post-baseline)

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.

Outcome measures

Outcome measures
Measure	Placebo n=1 Participants 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 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.
Change From Baseline in the Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS) to Day 1 of the Maintenance Period	-0.5 units on a scale Standard Deviation NA The mean presented here is the individual change in NADCS (from Baseline to Day 1 of the Maintenance Period) of the only subject included.	—

SECONDARY outcome

Timeframe: From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)

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.

Outcome measures

Outcome measures
Measure	Placebo n=1 Participants 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 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.
Change From Baseline in the Nocturnal Akinesia, Dystonia and Cramps Score (NADCS) to Week 4 of the Maintenance Period	-0.5 units on a scale Standard Deviation NA The mean presented here is the individual change in NADCS (from Baseline to Week 4 of the Maintenance Period) of the only subject included.	—

SECONDARY outcome

Timeframe: From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)

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).

Outcome measures

Outcome measures
Measure	Placebo n=1 Participants 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 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.
Change From Baseline in the Total Wake Time After Sleep Onset (WASO) to Week 4 of the Maintenance Period	20 minutes Standard Deviation NA 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.	—

SECONDARY outcome

Timeframe: From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)

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.

Outcome measures

Outcome measures
Measure	Placebo n=1 Participants 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 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.
Change From Baseline in the Total Number of Turnings in Bed to Week 4 of the Maintenance Period	0 Number of turnings in bed	—

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Rotigotine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=1 participants at risk 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 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.
Gastrointestinal disorders Constipation	100.0% 1/1 • Adverse Events were collected from Baseline to the Safety Follow-Up Visit at Week 18.	— 0/0 • Adverse Events were collected from Baseline to the Safety Follow-Up Visit at Week 18.
Infections and infestations Rhinitis	100.0% 1/1 • Adverse Events were collected from Baseline to the Safety Follow-Up Visit at Week 18.	— 0/0 • Adverse Events were collected from Baseline to the Safety Follow-Up Visit at Week 18.
Ear and labyrinth disorders Vertigo	100.0% 1/1 • Adverse Events were collected from Baseline to the Safety Follow-Up Visit at Week 18.	— 0/0 • Adverse Events were collected from Baseline to the Safety Follow-Up Visit at Week 18.
Nervous system disorders Lethargy	100.0% 1/1 • Adverse Events were collected from Baseline to the Safety Follow-Up Visit at Week 18.	— 0/0 • Adverse Events were collected from Baseline to the Safety Follow-Up Visit at Week 18.
Nervous system disorders Tension Headache	100.0% 1/1 • Adverse Events were collected from Baseline to the Safety Follow-Up Visit at Week 18.	— 0/0 • Adverse Events were collected from Baseline to the Safety Follow-Up Visit at Week 18.

Additional Information

UCB Clinical Trial Call Center

UCB

Phone: +1 877 822 9493 (UCB)

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60