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Trial record 17 of 18 for:    "Basal Ganglia Disease" | "Benserazide"

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

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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:
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
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
Hide 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
Arm/Group Title Placebo Rotigotine Total Title
Hide 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
Hide 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)
1.Primary Outcome
Title Absolute Change in Absolute Time Spent 'Off' From Baseline to the End of Double-blind Maintenance Period
Hide 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)
Hide Outcome Measure Data
Hide 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)
Hide 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)
Show Statistical Analysis 1 Hide 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
Hide 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)
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide 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)
Hide 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)
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
Hide 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   --/--      --/--    
Show Serious Adverse Events Hide 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
Show Other (Not Including Serious) Adverse Events Hide 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
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
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: UCB
Phone: +1877 822 ext 9493
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01646255     History of Changes
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