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Trial record 1 of 1 for:    NCT01523301
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Rotigotine Versus Placebo to Evaluate the Efficacy on Depressive Symptoms in Idiopathic Parkinson's Disease Patients

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ClinicalTrials.gov Identifier: NCT01523301
Recruitment Status : Completed
First Posted : February 1, 2012
Results First Posted : December 18, 2015
Last Update Posted : December 18, 2015
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Korea Co., Ltd. )

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
Enrollment 380
Recruitment Details This double-blind, randomized, multicenter, placebo-controlled, in-Patient study started recruiting in April 2012.
Pre-assignment Details Participant flow refers to the Randomized Set (RS), consisting of all randomized subjects.
Arm/Group Title Rotigotine Placebo
Hide Arm/Group Description

Rotigotine, daily doses, treatment Group.

Early-stage Parkinon´s disease for 1 week: Rotigotine dose at 2 mg/24 h. Advanced-stage Parkinson´s disease for 1 week: Rotigotine dose at 4 mg/24 h.

Afterwards the dose has been increased in the Titration Period by 2 mg/24 h each week until either the optimal or maximal dose was reached.

All subjects remained 8-weeks in the Maintenance Period. In the De-escalation Period Subjects with early-stage Parkinson´s disease de-escalated their dose by 2 mg/24 h every other day to 2 mg/24h, and then to 0 mg after 2 days. Subjects with advanced-stage Parkinson´s disease de-escalated their dose by 2 mg/24h every other day to 4 mg/24h, and then to 0 mg after 2 days.

A Safety Follow-Up Visit was scheduled for all subjects 30 days after their last dose administration.

Placebo, daily doses, placebo Group. Subjects randomized to placebo received matching placebo patches.

Early-stage Parkinson´s disease for 1 week: Placebo patches´ dose at 2 mg/24 h. Advanced-stage Parkinson´s disease for 1 week: Placebo patches´dose at 4 mg/24 h.

Afterwards the dose has been increased in the Titration Period by 2 mg/24 h each week until either the optimal or maximal dose was reached.

All subjects remained 8-weeks in the Maintenance Period.

In the De-escalation Period Subjects with early-stage Parkinson´s disease de-escalated their dose by 2 mg/24 h every other day to 2 mg/24h, and then to 0 mg after 2 days. Subjects with advanced-stage Parkinson´s disease de-escalated their dose by 2 mg/24h every other day to 4 mg/24h, and then to 0 mg after 2 days.

A Safety Follow-Up Visit was scheduled for all subjects 30 days after their last dose administration.

Period Title: Overall Study
Started 184 196
Completed 149 164
Not Completed 35 32
Reason Not Completed
Adverse Event             25             16
Lack of Efficacy             0             2
Protocol Violation             3             4
Lost to Follow-up             1             0
Withdrawal by Subject             6             8
Other Reason             0             2
Arm/Group Title Rotigotine Placebo Total Title
Hide Arm/Group Description

Rotigotine, daily doses, treatment Group.

Early-stage Parkinon´s disease for 1 week: Rotigotine dose at 2 mg/24 h. Advanced-stage Parkinson´s disease for 1 week: Rotigotine dose at 4 mg/24 h.

Afterwards the dose has been increased in the Titration Period by 2 mg/24 h each week until either the optimal or maximal dose was reached.

All subjects remained 8-weeks in the Maintenance Period. In the De-escalation Period Subjects with early-stage Parkinson´s disease de-escalated their dose by 2 mg/24 h every other day to 2 mg/24h, and then to 0 mg after 2 days. Subjects with advanced-stage Parkinson´s disease de-escalated their dose by 2 mg/24h every other day to 4 mg/24h, and then to 0 mg after 2 days.

A Safety Follow-Up Visit was scheduled for all subjects 30 days after their last dose administration.

Placebo, daily doses, placebo Group. Subjects randomized to placebo received matching placebo patches.

Early-stage Parkinson´s disease for 1 week: Placebo patches´ dose at 2 mg/24 h. Advanced-stage Parkinson´s disease for 1 week: Placebo patches´dose at 4 mg/24 h.

Afterwards the dose has been increased in the Titration Period by 2 mg/24 h each week until either the optimal or maximal dose was reached.

All subjects remained 8-weeks in the Maintenance Period.

In the De-escalation Period Subjects with early-stage Parkinson´s disease de-escalated their dose by 2 mg/24 h every other day to 2 mg/24h, and then to 0 mg after 2 days. Subjects with advanced-stage Parkinson´s disease de-escalated their dose by 2 mg/24h every other day to 4 mg/24h, and then to 0 mg after 2 days.

A Safety Follow-Up Visit was scheduled for all subjects 30 days after their last dose administration.

[Not Specified]
Overall Number of Baseline Participants 184 196 380
Hide Baseline Analysis Population Description
Baseline Characteristics refer to the Randomized Set (RS), which consists of all randomized subjects.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 184 participants 196 participants 380 participants
65.6  (8.9) 64.9  (8.2) 65.2  (8.5)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 184 participants 196 participants 380 participants
<=18 years 0 0 0
>18-<65 years 76 88 164
>=65 years 108 108 216
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 184 participants 196 participants 380 participants
Female
96
  52.2%
122
  62.2%
218
  57.4%
Male
88
  47.8%
74
  37.8%
162
  42.6%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 184 participants 196 participants 380 participants
61.54  (9.68) 62.24  (9.84) 61.90  (9.76)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 184 participants 196 participants 380 participants
160.04  (8.41) 159.17  (8.14) 159.59  (8.27)
1.Primary Outcome
Title Change From Baseline to the End of Maintenance Period in the Score of the Hamilton Depression Scale (HAM-D)
Hide Description The HAM-D consists of 17 items. Nine of the items are scored on a 5-point scale, ranging from 0 to 4. The remaining 8 items are scored on a 3-point scale, from 0 to 2. Therefore, the total score ranges between 0 to 52, with a cutoff score of 15/16 diagnosing major depressive disorder.
Time Frame From Baseline (Week 0) to end of Maintenance Period (up to Week 15)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Set (EES) consisted of all subjects from the Full Analysis Set (FAS) with a baseline total HAM-D score of 12 or larger.
Arm/Group Title Efficacy Evaluable Set (Rotigotine Treated Subjects) Efficacy Evaluable Set (Placebo Treated Subjects)
Hide Arm/Group Description:
Rotigotine, daily doses, treatment Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
Placebo, daily doses, placebo Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
Overall Number of Participants Analyzed 120 131
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-4.79
(-5.87 to -3.71)
-3.68
(-4.68 to -2.67)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Efficacy Evaluable Set (Rotigotine Treated Subjects), Efficacy Evaluable Set (Placebo Treated Subjects)
Comments The change from Baseline to the end of the Maintenance period in the score of the HAM-D of rotigotine-treated subjects has been compared with those subjects on placebo in the EES. The null hypothesis (H0) was that there was no difference in the change of the HAM-D score between the active treatment and the placebo group. The alternative hypothesis (H1) was that there was a difference in the change of HAM-D score between the rotigotine and the placebo arm.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.1286
Comments The null hypothesis was assessed with a 2-sided test and not rejected at p≤0.05.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -1.12
Confidence Interval (2-Sided) 95%
-2.56 to 0.33
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline to the End of Maintenance Period in the Score of Beck Depression Inventory (BDI-II)
Hide Description The Beck Depression Inventory II (BDI-II) is a self-report instrument to measure Depression symptoms and severity. There are 21 items in the BDI-II. Scores of 0-13 are considered minimal depression; 14-19 indicates mild depression; 20-28 indicates moderate depression; and 29-63 indicates severe depression.
Time Frame From Baseline (Week 0) to end of Maintenance Period (up to Week 15)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Set (EES) consisted of all subjects from the Full Analysis Set (FAS) with a baseline total HAM-D score of 12 or larger.
Arm/Group Title Efficacy Evaluable Set (Rotigotine Treated Subjects) Efficacy Evaluable Set (Placebo Treated Subjects)
Hide Arm/Group Description:
Rotigotine, daily doses, treatment Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
Placebo, daily doses, placebo Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
Overall Number of Participants Analyzed 120 131
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-5.87
(-7.39 to -4.34)
-4.68
(-6.11 to -3.26)
3.Secondary Outcome
Title Change From Baseline to the End of Maintenance Period in the Score of Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living-ADL Subscale)
Hide Description The UPDRS Part II is a tool to measure Activities in Daily Living - it includes speech, salivation, swallowing, handwriting, cutting food and handling utensils, dressing, hygiene, turning in bed and adjusting clothes, falling (unrelated to freezing), freezing when walking, walking, tremor, and sensory complaints related to Parkinsonism. Each of the 13 questions is measured on a scale from 0 (normal) to 4 (severe). The total score of UPDRS part II ranges from 0 (normal) to 52 (severe).
Time Frame From Baseline (Week 0) to end of Maintenance Period (up to Week 15)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Set (EES) consisted of all subjects from the Full Analysis Set (FAS) with a baseline total HAM-D score of 12 or larger.
Arm/Group Title Efficacy Evaluable Set (Rotigotine Treated Subjects) Efficacy Evaluable Set (Placebo Treated Subjects)
Hide Arm/Group Description:
Rotigotine, daily doses, treatment Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
Placebo, daily doses, placebo Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
Overall Number of Participants Analyzed 120 131
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-1.13
(-1.76 to -0.50)
-0.10
(-0.69 to 0.49)
4.Secondary Outcome
Title Change From Baseline to the End of Maintenance Period in the Score of Unified Parkinson's Disease Rating Scale (UPDRS) Part III (Motor Subscale)
Hide Description Improvement of motor symptoms is measured by the change from Baseline in UPDRS Part III motor score. The UPDRS Part III is an accepted and validated scale for the assessment of motor function in Parkinson's disease. Each of the elements in the UPDRS Part III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. The total score of UPDRS part III ranges from 0 (normal) to 108 (severe abnormalities).
Time Frame From Baseline (Week 0) to end of Maintenance Period (up to Week 15)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Set (EES) consisted of all subjects from the Full Analysis Set (FAS) with a baseline total HAM-D score of 12 or larger.
Arm/Group Title Efficacy Evaluable Set (Rotigotine Treated Subjects) Efficacy Evaluable Set (Placebo Treated Subjects)
Hide Arm/Group Description:
Rotigotine, daily doses, treatment Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
Placebo, daily doses, placebo Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
Overall Number of Participants Analyzed 120 131
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-3.07
(-4.28 to -1.86)
-1.65
(-2.78 to -0.52)
5.Secondary Outcome
Title Change From Baseline to the End of Maintenance Period in the Combined Score of Unified Parkinson's Disease Rating Scale (UPDRS) Part II (ADL) Plus Part III (Motor Subscale)
Hide Description The combined score of UPDRS part II and UPDRS part III is the sum of the individual scores and threfore ranges from 0 (normal) to 160 (severe).
Time Frame From Baseline (Week 0) to end of Maintenance Period (up to Week 15)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Set (EES) consisted of all subjects from the Full Analysis Set (FAS) with a baseline total HAM-D score of 12 or larger.
Arm/Group Title Efficacy Evaluable Set (Rotigotine Treated Subjects) Efficacy Evaluable Set (Placebo Treated Subjects)
Hide Arm/Group Description:
Rotigotine, daily doses, treatment Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
Placebo, daily doses, placebo Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
Overall Number of Participants Analyzed 120 131
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-4.20
(-5.79 to -2.62)
-1.81
(-3.29 to -0.33)
6.Secondary Outcome
Title Change From Baseline to the End of Maintenance Period in the Score of Apathy Scale (AS)
Hide Description The AS is an abbreviated version of the Apathy Scale (AS). The AS consists of 14 items phrased as questions that are to be answered on a four-point Likert scale. It was developed specifically for patients with Parkinson Disease (PD). For questions 1-8, the scoring system is the following: not at all = 3 points; slightly = 2 points; some =1 point, a lot = 0 point. For questions 9-14: the scoring system is the following: not at all = 0 points; slightly = 1 point; some = 2 points; a lot = 3 points. Adding all scores provides the final score with a range from 0 to 42.
Time Frame From Baseline (Week 0) to end of Maintenance Period (up to Week 15)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Set (EES) consisted of all subjects from the Full Analysis Set (FAS) with a baseline total HAM-D score of 12 or larger.
Arm/Group Title Efficacy Evaluable Set (Rotigotine Treated Subjects) Efficacy Evaluable Set (Placebo Treated Subjects)
Hide Arm/Group Description:
Rotigotine, daily doses, treatment Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
Placebo, daily doses, placebo Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
Overall Number of Participants Analyzed 120 131
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-1.93
(-2.83 to -1.04)
-0.67
(-1.50 to 0.17)
7.Secondary Outcome
Title Change From Baseline to the End of Maintenance Period in the Score of Snaith-Hamilton Pleasure Scale (SHAPS)
Hide Description The SHAPS is a self-report instrument developed for the assessment of hedonic capacity. The sum of the 14 items scores ranges from 0 to 14. A higher score represents more anhedonic symptoms.
Time Frame From Baseline (Week 0) to end of Maintenance Period (up to Week 15)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Set (EES) consisted of all subjects from the Full Analysis Set (FAS) with a baseline total HAM-D score of 12 or larger.
Arm/Group Title Efficacy Evaluable Set (Rotigotine Treated Subjects) Efficacy Evaluable Set (Placebo Treated Subjects)
Hide Arm/Group Description:
Rotigotine, daily doses, treatment Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
Placebo, daily doses, placebo Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
Overall Number of Participants Analyzed 120 131
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-0.82
(-1.28 to -0.37)
-0.60
(-1.03 to -0.17)
Time Frame Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
Adverse Event Reporting Description TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
 
Arm/Group Title Rotigotine Placebo
Hide Arm/Group Description

Rotigotine, daily doses, treatment Group.

Early-stage Parkinon´s disease for 1 week: Rotigotine dose at 2 mg/24 h. Advanced-stage Parkinson´s disease for 1 week: Rotigotine dose at 4 mg/24 h.

Afterwards the dose has been increased in the Titration Period by 2 mg/24 h each week until either the optimal or maximal dose was reached.

All subjects remained 8-weeks in the Maintenance Period. In the De-escalation Period Subjects with early-stage Parkinson´s disease de-escalated their dose by 2 mg/24 h every other day to 2 mg/24h, and then to 0 mg after 2 days. Subjects with advanced-stage Parkinson´s disease de-escalated their dose by 2 mg/24h every other day to 4 mg/24h, and then to 0 mg after 2 days.

A Safety Follow-Up Visit was scheduled for all subjects 30 days after their last dose administration.

Placebo, daily doses, placebo Group. Subjects randomized to placebo received matching placebo patches.

Early-stage Parkinson´s disease for 1 week: Placebo patches´ dose at 2 mg/24 h. Advanced-stage Parkinson´s disease for 1 week: Placebo patches´dose at 4 mg/24 h.

Afterwards the dose has been increased in the Titration Period by 2 mg/24 h each week until either the optimal or maximal dose was reached.

All subjects remained 8-weeks in the Maintenance Period.

In the De-escalation Period Subjects with early-stage Parkinson´s disease de-escalated their dose by 2 mg/24 h every other day to 2 mg/24h, and then to 0 mg after 2 days. Subjects with advanced-stage Parkinson´s disease de-escalated their dose by 2 mg/24h every other day to 4 mg/24h, and then to 0 mg after 2 days.

A Safety Follow-Up Visit was scheduled for all subjects 30 days after their last dose administration.

All-Cause Mortality
Rotigotine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Rotigotine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/184 (3.26%)      14/196 (7.14%)    
Cardiac disorders     
Angina pectoris * 1  0/184 (0.00%)  0 1/196 (0.51%)  1
Congenital, familial and genetic disorders     
Spondylolisthesis * 1  1/184 (0.54%)  1 0/196 (0.00%)  0
Gastrointestinal disorders     
Small intestinal obstruction * 1  0/184 (0.00%)  0 1/196 (0.51%)  1
General disorders     
Chest discomfort * 1  0/184 (0.00%)  0 1/196 (0.51%)  4
Hepatobiliary disorders     
Hepatitis * 1  1/184 (0.54%)  1 0/196 (0.00%)  0
Jaundice * 1  1/184 (0.54%)  1 0/196 (0.00%)  0
Bile duct stone * 1  0/184 (0.00%)  0 1/196 (0.51%)  1
Immune system disorders     
Kidney transplant rejection * 1  1/184 (0.54%)  1 0/196 (0.00%)  0
Injury, poisoning and procedural complications     
Contusion * 1  0/184 (0.00%)  0 1/196 (0.51%)  1
Fall * 1  0/184 (0.00%)  0 1/196 (0.51%)  1
Jaw fracture * 1  0/184 (0.00%)  0 2/196 (1.02%)  2
Ligament rupture * 1  0/184 (0.00%)  0 1/196 (0.51%)  2
Skin laceration * 1  0/184 (0.00%)  0 1/196 (0.51%)  1
Musculoskeletal and connective tissue disorders     
Intervertebral disc protrusion * 1  1/184 (0.54%)  1 0/196 (0.00%)  0
Myalgia * 1  1/184 (0.54%)  1 0/196 (0.00%)  0
Osteoarthritis * 1  1/184 (0.54%)  1 0/196 (0.00%)  0
Back Pain * 1  0/184 (0.00%)  0 1/196 (0.51%)  1
Lumbar spinal stenosis * 1  0/184 (0.00%)  0 1/196 (0.51%)  1
Rotator cuff syndrome * 1  0/184 (0.00%)  0 1/196 (0.51%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cervix carcinoma stage IV * 1  0/184 (0.00%)  0 1/196 (0.51%)  1
Nervous system disorders     
Dizziness * 1  1/184 (0.54%)  1 0/196 (0.00%)  0
Tremor * 1  1/184 (0.54%)  1 0/196 (0.00%)  0
Headache * 1  0/184 (0.00%)  0 1/196 (0.51%)  1
Psychiatric disorders     
Anxiety * 1  0/184 (0.00%)  0 1/196 (0.51%)  1
Suicide attempt * 1  0/184 (0.00%)  0 1/196 (0.51%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA9.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rotigotine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   112/184 (60.87%)      91/196 (46.43%)    
Gastrointestinal disorders     
Nausea * 1  42/184 (22.83%)  52 15/196 (7.65%)  16
Vomiting * 1  13/184 (7.07%)  14 2/196 (1.02%)  2
Constipation * 1  10/184 (5.43%)  12 10/196 (5.10%)  10
General disorders     
Application site pruritus * 1  19/184 (10.33%)  20 10/196 (5.10%)  12
Application site erythema * 1  11/184 (5.98%)  11 5/196 (2.55%)  6
Asthenia * 1  5/184 (2.72%)  5 11/196 (5.61%)  13
Infections and infestations     
Nasopharyngitis * 1  7/184 (3.80%)  8 13/196 (6.63%)  15
Nervous system disorders     
Dizziness * 1  28/184 (15.22%)  31 25/196 (12.76%)  27
Headache * 1  19/184 (10.33%)  22 20/196 (10.20%)  23
Psychiatric disorders     
Suicidal ideation * 1  21/184 (11.41%)  25 22/196 (11.22%)  25
Insomnia * 1  13/184 (7.07%)  13 6/196 (3.06%)  7
Skin and subcutaneous tissue disorders     
Pruritus * 1  12/184 (6.52%)  12 2/196 (1.02%)  3
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA9.1
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 9493
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB Korea Co., Ltd. )
ClinicalTrials.gov Identifier: NCT01523301    
Other Study ID Numbers: SP1041
First Submitted: January 27, 2012
First Posted: February 1, 2012
Results First Submitted: October 12, 2015
Results First Posted: December 18, 2015
Last Update Posted: December 18, 2015