Rotigotine Versus Placebo, A Study To Evaluate The Efficacy In Advanced Stage Idiopathic Parkinson's Disease Patients

• ClinicalTrials.gov Identifier: NCT01646255
• Recruitment Status: Completed
• First Posted: July 20, 2012
• Results First Posted: January 22, 2016
• Last Update Posted: April 4, 2018
• Sponsor: UCB Pharma
• Collaborator: UCB Trading (Shanghai) Co. Ltd.
• Information provided by (Responsible Party): UCB Pharma

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Idiopathic Parkinson's Disease
• Interventions: Drug: Rotigotine; Drug: Placebo Patch; Drug: L-dopa
• Enrollment: 346

Participant Flow

Recruitment Details	This multicenter, randomized, double-blind, parallel-group, placebo-controlled study started recruiting in August 2012.
Pre-assignment Details	Participant Flow refers to the Safety Set (SS), consisting of all randomized subjects who received at least 1 dose of study medication.

Arm/Group Title	Placebo	Rotigotine
Arm/Group Description	Subjects randomized to placebo received matching placebo patches.	Subjects received rotigotine in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h or matching placebo) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h was achieved. Each dose level was maintained for 1 week.
Period Title: Overall Study
Started	172	174
Completed	151	160
Not Completed	21	14
Reason Not Completed
Adverse Event	7	8
Lack of Efficacy	2	0
Withdrawal by Subject	10	6
Compliance is not well	1	0
Inclusion Criteria Deviation	1	0

Baseline Characteristics

Arm/Group Title		Placebo	Rotigotine	Total Title
Arm/Group Description		Subjects randomized to placebo received matching placebo patches.	Subjects received rotigotine in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h or matching placebo) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h was achieved. Each dose level was maintained for 1 week.	[Not Specified]
Overall Number of Baseline Participants		172	174	346
Baseline Analysis Population Description		Baseline Characteristics refers to to the Safety Set (SS), consisting of all randomized subjects who received at least 1 dose of study medication.
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	172 participants	174 participants	346 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	96 55.8%	111 63.8%	207 59.8%
	>=65 years	76 44.2%	63 36.2%	139 40.2%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
mean (standard deviation)	Number Analyzed	172 participants	174 participants	346 participants
		62.8 (9.1)	61.7 (8.8)	62.2 (8.9)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	172 participants	174 participants	346 participants
	Female	62 36.0%	81 46.6%	143 41.3%
	Male	110 64.0%	93 53.4%	203 58.7%
Weight; Mean (Standard Deviation); Unit of measure: Kg
	Number Analyzed	172 participants	174 participants	346 participants
		61.83 (10.18)	60.38 (10.15)	61.10 (10.18)

Outcome Measures

1. Primary Outcome

Title	Absolute Change in Absolute Time Spent 'Off' From Baseline to the End of Double-blind Maintenance Period
Description	A subject has been considered "off" when he/she began to lose the optimum effects of anti-Parkinson's medication. A negative mean indicates a reduction of the time off during the conduct of the study
Time Frame	From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.

Arm/Group Title	Full Analysis Set (Placebo Treated Subjects)	Full Analysis Set (Rotigotine Treated Subjects)
Arm/Group Description:	Subjects randomized to placebo received matching placebo patches.	Subjects received rotigotine in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h or matching placebo) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h was achieved. Each dose level was maintained for 1 week.
Overall Number of Participants Analyzed	168	170
Mean (Standard Deviation); Unit of Measure: hours
	-1.13 (3.20)	-2.36 (2.83)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Full Analysis Set (Placebo Treated Subjects), Full Analysis Set (Rotigotine Treated Subjects)
	Comments	Estimate of treatment effect has been obtained from an analysis of covariance (ANCOVA) model to the change from Baseline value in absolute time spent "off". The ANCOVA model contained treatment and (pooled) site as factors and Baseline "off" time as covariate. A last observation carried forward (LOCF) imputation approach was used for missing values (during both Titration and Maintenance Periods) for the primary efficacy analysis.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	=0.0002
	Comments	Primary efficacy analyses was made with confirmatory 2-sided test with significance level 0.05.
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Square Mean
	Estimated Value	-1.20
	Confidence Interval	(2-Sided) 95%; -1.83 to -0.57
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	Percentage of Responders From Baseline to the End of the Doubleblind Maintenance Period
Description	A Responder is defined as a subject with an ≥ 30 % decrease in absolute time spent 'off'
Time Frame	From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.

Arm/Group Title	Full Analysis Set (Placebo Treated Subjects)	Full Analysis Set (Rotigotine Treated Subjects)
Arm/Group Description:	Subjects randomized to placebo received matching placebo patches.	Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
Overall Number of Participants Analyzed	168	170
Measure Type: Number; Unit of Measure: percentage of participants
	36.9	48.8

3. Secondary Outcome

Title	Percent Change in Absolute Time Spent "Off" From Baseline to the End of Double-blind Maintenance Period
Description	A subject has been considered "off" when he/she began to lose the optimum effects of anti-Parkinson's medication. Absolute time "off" is defined as the mean number of hours marked "off" during a 24-hour period from all valid daily diary cards.
Time Frame	From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.

Arm/Group Title	Full Analysis Set (Placebo Treated Subjects)	Full Analysis Set (Rotigotine Treated Subjects)
Arm/Group Description:	Subjects randomized to placebo received matching placebo patches.	Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
Overall Number of Participants Analyzed	168	170
Mean (Standard Deviation); Unit of Measure: percent change
	-15.0 (56.56)	-36.03 (43.03)

4. Secondary Outcome

Title	Percent Change in Relative Time Spent "Off" From Baseline to the End of Double-blind Maintenance Period
Description	A subject has been considered "off" when he/she began to lose the optimum effects of anti-Parkinson's medication. Relative time spent "off" will be calculated in two stages. Each valid daily diary will have an associated relative time "off" calculated as relative time "off" for day = 100*[total absolute time "off" for day/ absolute time awake for day]. Relative time spent "off" is then calculated by averaging the daily relative time "off" for the valid days of that visit.
Time Frame	From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.

Arm/Group Title	Full Analysis Set (Placebo Treated Subjects)	Full Analysis Set (Rotigotine Treated Subjects)
Arm/Group Description:	Subjects randomized to placebo received matching placebo patches.	Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
Overall Number of Participants Analyzed	168	170
Mean (Standard Deviation); Unit of Measure: percent change
	-14.86 (53.26)	-34.97 (43.87)

5. Secondary Outcome

Title	Change in Absolute Time Spent "on" From Baseline to the End of Double-blind Maintenance Period
Description	A subject has been considered "on" when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'. Absolute time "on" is defined as the mean number of hours marked "on" during a 24-hour period from all valid daily diary cards.
Time Frame	From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.

Arm/Group Title	Full Analysis Set (Placebo Treated Subjects)	Full Analysis Set (Rotigotine Treated Subjects)
Arm/Group Description:	Subjects randomized to placebo received matching placebo patches.	Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
Overall Number of Participants Analyzed	168	170
Mean (Standard Deviation); Unit of Measure: hours
	0.94 (3.08)	2.05 (2.98)

6. Secondary Outcome

Title	Change in Relative Time Spent "on" From Baseline to the End of Double-blind Maintenance Period
Description	A subject has been considered "on" when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was "off" when taking his/her L-dopa, he/she recorded the exact time their status changed to "on". Relative time spent "on" will be calculated in two stages. Each valid daily diary will have an associated relative time "on" calculated as relative time "on" for day = 100*[total absolute time "on" for day/ absolute time awake for day]. Relative time spent "on" is then calculated by averaging the daily relative time "on" for the valid days of that visit.
Time Frame	From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.

Arm/Group Title	Full Analysis Set (Placebo Treated Subjects)	Full Analysis Set (Rotigotine Treated Subjects)
Arm/Group Description:	Subjects randomized to placebo received matching placebo patches.	Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
Overall Number of Participants Analyzed	168	170
Mean (Standard Deviation); Unit of Measure: hours
	6.78 (19.61)	14.49 (18.70)

7. Secondary Outcome

Title	Percent Change in Absolute Time Spent "on" From Baseline to the End of Double-blind Maintenance Period
Description	A subject has been considered "on" when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'. Note for percent change calculations: when absolute time at Baseline was 0 hours, the absolute Baseline value was assumed to be 1 minute for calculation purposes.
Time Frame	From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.

Arm/Group Title	Full Analysis Set (Placebo Treated Subjects)	Full Analysis Set (Rotigotine Treated Subjects)
Arm/Group Description:	Subjects randomized to placebo received matching placebo patches.	Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
Overall Number of Participants Analyzed	168	170
Mean (Standard Deviation); Unit of Measure: percent change
	13.53 (42.74)	368.55 (4446.55)

8. Secondary Outcome

Title	Percent Change in Relative Time Spent "on" From Baseline to the End of Double-blind Maintenance Period
Description	A subject has been considered "on" when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was "off" when taking his/her L-dopa, he/she recorded the exact time their status changed to "on". Note for percent change calculations: when relative time at Baseline was 0%, the relative Baseline value was assumed to be 0.1 for calculation purposes. Relative time spent "on" will be calculated in two stages. Each valid daily diary will have an associated relative time "on" calculated as relative time "on" for day = 100*[total absolute time "on" for day/ absolute time awake for day]. Relative time spent "on" is then calculated by averaging the daily relative time "on" for the valid days of that visit.
Time Frame	From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.

Arm/Group Title	Full Analysis Set (Placebo Treated Subjects)	Full Analysis Set (Rotigotine Treated Subjects)
Arm/Group Description:	Subjects randomized to placebo received matching placebo patches.	Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
Overall Number of Participants Analyzed	168	170
Mean (Standard Deviation); Unit of Measure: percent change
	14.99 (42.60)	616.80 (7667.58)

9. Secondary Outcome

Title	Change in the Number of "Off" Periods From Baseline to the End of Double-blind Maintenance Period
Description	A subject has been considered "off" when he/she began to lose the optimum effects of anti-Parkinson's medication.
Time Frame	From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.

Arm/Group Title	Full Analysis Set (Placebo Treated Subjects)	Full Analysis Set (Rotigotine Treated Subjects)
Arm/Group Description:	Subjects randomized to placebo received matching placebo patches.	Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
Overall Number of Participants Analyzed	168	170
Mean (Standard Deviation); Unit of Measure: Number of 'off' Periods
	-0.61 (1.59)	-0.89 (1.32)

10. Secondary Outcome

Title	Change in Status of the Subject (on) After Wake-up With Troublesome Dyskinesia From Baseline to the End of Double-blind Maintenance Period
Description	A subject has been considered "on" when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'. The percentage of days from Baseline to the end of the double-blind Maintenance Period in which the subject woke in the "on with troublesome dyskinesia" state is presented below.
Time Frame	From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.

Arm/Group Title	Full Analysis Set (Placebo Treated Subjects)	Full Analysis Set (Rotigotine Treated Subjects)
Arm/Group Description:	Subjects randomized to placebo received matching placebo patches.	Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
Overall Number of Participants Analyzed	168	170
Mean (Standard Deviation); Unit of Measure: percentage of days
	2.42 (21.70)	1.24 (16.90)

11. Secondary Outcome

Title	Change in Status of the Subject (on) After Wake-up Without Troublesome Dyskinesia From Baseline to the End of Double-blind Maintenance Period
Description	A subject has been considered "on" when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'. The percentage of days from Baseline to the end of the double-blind Maintenance Period in which the subject woke in the "on without troublesome dyskinesia" state is presented below.
Time Frame	From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.

Arm/Group Title	Full Analysis Set (Placebo Treated Subjects)	Full Analysis Set (Rotigotine Treated Subjects)
Arm/Group Description:	Subjects randomized to placebo received matching placebo patches.	Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
Overall Number of Participants Analyzed	168	170
Mean (Standard Deviation); Unit of Measure: percentage of days
	7.92 (43.29)	22.55 (45.41)

12. Secondary Outcome

Title	Change in Status of the Subject (Off) After Wake-up From Baseline to the End of Double-blind Maintenance Period
Description	A subject has been considered "off" when he/she began to lose the optimum effects of anti-Parkinson's medication. The percentage of days from Baseline to the end of the double-blind Maintenance Period in which the subject woke in the "off" state is presented below.
Time Frame	From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.

Arm/Group Title	Full Analysis Set (Placebo Treated Subjects)	Full Analysis Set (Rotigotine Treated Subjects)
Arm/Group Description:	Subjects randomized to placebo received matching placebo patches.	Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
Overall Number of Participants Analyzed	168	170
Mean (Standard Deviation); Unit of Measure: percentage of days
	-10.34 (47.81)	-21.14 (48.49)

13. Secondary Outcome

Title	Change in Unified Parkinson's Disease Rating Scale (UPDRS Part III Motor Examination) During "on" Periods From Baseline to the End of Double-blind Maintenance Period
Description	The UPDRS Part III (motor subscale) assessment consists of 27 questions, measured on a 5-Point scale (0 to 4). The sum score is calculated as sum of these 27 individual questions. This score ranges from 0 to 108, higher scores denote greater disability. A subject has been considered "on" when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'.
Time Frame	From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.

Arm/Group Title	Full Analysis Set (Placebo Treated Subjects)	Full Analysis Set (Rotigotine Treated Subjects)
Arm/Group Description:	Subjects randomized to placebo received matching placebo patches.	Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
Overall Number of Participants Analyzed	168	170
Mean (Standard Deviation); Unit of Measure: units on a scale
	-3.6 (9.8)	-10.4 (10.4)

Adverse Events

Time Frame	Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in August 2012 and concluded in October 2014.
Adverse Event Reporting Description	TEAEs are comprised of the Safety Population (SS), which consists of all randomized subjects who received at least 1 dose of study medication.
Arm/Group Title	Placebo		Rotigotine
Arm/Group Description	Placebo, daily doses, placebo Group Subjects randomized to placebo will receive matching placebo patches.		Rotigotine, daily doses, treatment Group Subjects will receive rotigotine or placebo patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h or matching placebo) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo is achieved. A combination of patches (rotigotine or matching placebo) will be applied for subjects who require a dose > 8 mg/ 24 h. Each dose level is maintained for 1 week.
All-Cause Mortality
	Placebo		Rotigotine
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events
	Placebo		Rotigotine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/172 (3.49%)		6/174 (3.45%)
Cardiac disorders
Mitral valve prolapse * 1	1/172 (0.58%)	1	0/174 (0.00%)	0
Atrial fibrillation * 1	1/172 (0.58%)	1	0/174 (0.00%)	0
Gastrointestinal disorders
Intestinal obstruction * 1	1/172 (0.58%)	1	0/174 (0.00%)	0
Inguinal hernia * 1	0/172 (0.00%)	0	1/174 (0.57%)	1
Gastrointestinal haemorrhage * 1	0/172 (0.00%)	0	1/174 (0.57%)	1
Infections and infestations
Skin infection * 1	0/172 (0.00%)	0	1/174 (0.57%)	1
Injury, poisoning and procedural complications
Spinal compression fracture * 1	0/172 (0.00%)	0	1/174 (0.57%)	1
Nervous system disorders
Syncope * 1	0/172 (0.00%)	0	2/174 (1.15%)	2
Parkinson's disease * 1	1/172 (0.58%)	1	0/174 (0.00%)	0
Renal and urinary disorders
Urinary retention * 1	1/172 (0.58%)	1	0/174 (0.00%)	0
Vascular disorders
Vasculitis * 1	1/172 (0.58%)	1	0/174 (0.00%)	0
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA16.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Placebo		Rotigotine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	24/172 (13.95%)		54/174 (31.03%)
Gastrointestinal disorders
Nausea * 1	2/172 (1.16%)	2	16/174 (9.20%)	23
Nervous system disorders
Dyskinesia * 1	7/172 (4.07%)	7	11/174 (6.32%)	13
Dizziness * 1	7/172 (4.07%)	8	19/174 (10.92%)	21
Skin and subcutaneous tissue disorders
Pruritus * 1	10/172 (5.81%)	11	14/174 (8.05%)	15
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA16.0

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

UCB has > 60 but <= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that the results shall be published regardless of outcome.

Results Point of Contact

• Name/Title: Study Director
• Organization: UCB
• Phone: +1877 822 ext 9493

Publications of Results:

Zhang ZX, Liu CF, Tao EX, Shao M, Liu YM, Wang J, Asgharnejad M, Xue HB, Surmann E, Bauer L. Rotigotine transdermal patch in Chinese patients with advanced Parkinson's disease: A randomized, double-blind, placebo-controlled pivotal study. Parkinsonism Relat Disord. 2017 Nov;44:6-12. doi: 10.1016/j.parkreldis.2017.08.015. Epub 2017 Aug 10.

• Responsible Party: UCB Pharma
• ClinicalTrials.gov Identifier: NCT01646255
• Other Study ID Numbers: SP1037
• First Submitted: July 18, 2012
• First Posted: July 20, 2012
• Results First Submitted: October 8, 2015
• Results First Posted: January 22, 2016
• Last Update Posted: April 4, 2018