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Trial record 1 of 1 for:    NCT01744496
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Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain (DOLORES)

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ClinicalTrials.gov Identifier: NCT01744496
Recruitment Status : Completed
First Posted : December 6, 2012
Results First Posted : December 2, 2014
Last Update Posted : May 1, 2015
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES GmbH )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Advanced Idiopathic Parkinson's Disease
Interventions Drug: Rotigotine
Drug: Placebo
Enrollment 68
Recruitment Details The study was conducted in Europe and USA. Recruitment was planned to continue until approximately 64 patients were randomized in the study. Subjects were randomized in a 1:1 ratio to either Rotigotine or Placebo. To achieve this, approximately 28 investigational sites were planned to participate in this hypothesis-generating pilot study.
Pre-assignment Details The Participant Flow population refers to the Randomized Set (RS). The RS includes all subjects who were randomized.
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description

Placebo Transdermal Patches

Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo will be decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days.

Rotigotine Transdermal Patches

Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days.

Period Title: Titration Period
Started 33 35
Completed 31 33
Not Completed 2 2
Reason Not Completed
Adverse Event             2             1
Personal reasons             0             1
Period Title: Maintenance Period
Started 31 33
Completed 27 29
Not Completed 4 4
Reason Not Completed
Adverse Event             1             3
Protocol Violation             1             0
Withdrawal by Subject             1             1
Subject left town             1             0
Arm/Group Title Placebo Rotigotine Total
Hide Arm/Group Description

Placebo Transdermal Patches

Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days.

Rotigotine Transdermal Patches

Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days.

Total of all reporting groups
Overall Number of Baseline Participants 33 35 68
Hide Baseline Analysis Population Description
The Baseline Analysis Population refers to the Safety Set (SS). The SS includes 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 33 participants 35 participants 68 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
  45.5%
12
  34.3%
27
  39.7%
>=65 years
18
  54.5%
23
  65.7%
41
  60.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants 35 participants 68 participants
65.3  (13.8) 66.5  (11.9) 65.9  (12.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 35 participants 68 participants
Female
16
  48.5%
16
  45.7%
32
  47.1%
Male
17
  51.5%
19
  54.3%
36
  52.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 33 participants 35 participants 68 participants
American Indian / Alaskan native 0 0 0
Asian 1 0 1
Black 0 0 0
Native Hawaiian or other Pacific Islander 0 0 0
White 32 35 67
Other / mixed 0 0 0
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 33 participants 35 participants 68 participants
80.15  (20.00) 77.80  (13.71) 78.94  (16.97)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 33 participants 35 participants 68 participants
167.17  (9.92) 168.63  (9.87) 167.92  (9.85)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kilogram per squaremeter
Number Analyzed 33 participants 35 participants 68 participants
28.54  (6.21) 27.42  (4.74) 27.96  (5.49)
1.Primary Outcome
Title Change From Baseline to the End of the Maintenance Period in Pain Severity Assessed Using an 11-point Likert Pain Scale
Hide Description

An 11-Point Likert Scale was used to assess patients' average daily pain. The subject rated his/her average pain from 0 (no pain) to 10 (worst pain ever experienced).

The average pain experienced in the last 7 days was calculated by the mean of the daily Likert Pain Scores within the 7 days prior to the respective visit (ie, Likert Pain Scores with a date of assessment before the date of visit and on or after the date of visit - 7 days). A negative value indicates an improvement.

Time Frame Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after an up to 7 weeks Titration Period)
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and includes all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement.
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo Transdermal Patches

Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days.

Rotigotine Transdermal Patches

Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days.

Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-2.2  (2.78) -2.8  (1.84)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Rotigotine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.172
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model for the change from Baseline to the End of Treatment containing treatment and region as factors and Baseline value as a covariate.
Method of Estimation Estimation Parameter Least Square Mean
Estimated Value -0.76
Confidence Interval (2-Sided) 95%
-1.87 to 0.34
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.55
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Responders at the End of the Maintenance Period
Hide Description Responders are defined as patients experiencing a 2-Point or more Reduction on an 11-Point Likert Pain Scale from Baseline to the End of the Maintenance Period. An 11-Point Likert Scale was used to assess patients' average daily pain. The patient rated his/her average pain from 0 (no pain) to 10 (worst pain ever experienced).
Time Frame Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and includes all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement.
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo Transdermal Patches

Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days.

Rotigotine Transdermal Patches

Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days.

Overall Number of Participants Analyzed 30 30
Measure Type: Number
Unit of Measure: percentage of responders
46.7 60
3.Secondary Outcome
Title Change From Baseline to the End of the Maintenance Period in the Sum Score of the 8-Item Parkinson's Disease Questionnaire (PDQ-8)
Hide Description The 8-Item Parkinson's Disease Questionnaire (PDQ-8) (Peto et al, 1998) is a self-administered questionnaire that provides a reliable measure of overall health status. The PDQ-8 contains 8 items of daily living, with 1 item selected from each of the following 8 scales: mobility, Activities of Daily Living (ADL), emotional well being, stigma, social support, cognitions, communication, and bodily discomfort. The total PDQ-8 score is the sum of all the individual items converted to a summary index score between 0 and 100, with lower scores indicating better health. A negative value indicates an improvement.
Time Frame Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and includes all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement.
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo Transdermal Patches

Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days.

Rotigotine Transdermal Patches

Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days.

Overall Number of Participants Analyzed 29 30
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-3.77  (13.93) -12.40  (19.25)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Rotigotine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.038
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model for the change from Baseline to the End of Treatment containing treatment and region as factors and Baseline value as a covariate.
Method of Estimation Estimation Parameter Least Square Mean
Estimated Value -8.01
Confidence Interval (2-Sided) 95%
-15.56 to -0.46
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.77
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline to the End of the Maintenance Period in the 7-Item Depression Subscore of the Hospital Anxiety and Depression Scale (HADS)
Hide Description The Hospital Anxiety and Depression Scale (HADS) (Zigmond and Snaith, 1983) is a 14-item self-assessment scale for detecting states of depression and anxiety in the setting of a hospital medical outpatient clinic. It comprises a 7-item anxiety subscale and a 7-item depressive subscale that are also measures of severity of the emotional disorder. The 14 items are scored between 0 and 3. The 7-item depression subscore and 7-item anxiety subscore were calculated as the sum of the 7 corresponding individual scores. A negative value indicates an improvement.
Time Frame Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and includes all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement.
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo Transdermal Patches

Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days.

Rotigotine Transdermal Patches

Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days.

Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-1.7  (4.3) -1.9  (4.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Rotigotine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.247
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model for the change from Baseline to the End of Treatment containing treatment and region as factors and Baseline value as a covariate.
Method of Estimation Estimation Parameter Least Square Mean
Estimated Value -1.02
Confidence Interval (2-Sided) 95%
-2.76 to 0.73
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.87
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline to the End of the Maintenance Period in the 7-Item Anxiety Subscore of the Hospital Anxiety and Depression Scale (HADS)
Hide Description The Hospital Anxiety and Depression Scale (HADS) (Zigmond and Snaith, 1983) is a 14-item self-assessment scale for detecting states of depression and anxiety in the setting of a hospital medical outpatient clinic. It comprises a 7-item anxiety subscale and a 7-item depressive subscale that are also measures of severity of the emotional disorder. The 14 items are scored between 0 and 3. The 7-item depression subscore and 7-item anxiety subscore were calculated as the sum of the 7 corresponding individual scores. A negative value indicates an improvement.
Time Frame Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and includes all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement.
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo Transdermal Patches

Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days.

Rotigotine Transdermal Patches

Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days.

Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-1.0  (3.2) -1.8  (3.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Rotigotine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.371
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model for the change from Baseline to the End of Treatment containing treatment and region as factors and Baseline value as a covariate.
Method of Estimation Estimation Parameter Least Square Mean
Estimated Value -0.58
Confidence Interval (2-Sided) 95%
-1.85 to 0.70
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.64
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline to the End of the Maintenance Period in the Combined Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II (Activities of Daily Living [ADL] Subscale) and III (Motor Subscale)
Hide Description Part II of the Unified Parkinson's Disease Rating Scale (UPDRS) assesses the subject's activities of daily living. Part III assesses motor function. The UPDRS is completed by questioning the subject about his/her general state in conjunction with any observations made by the investigator (or designee) since the previous visit. Part II is subject-rated and Part III is physician-rated. The UPDRS Part II (Activities of Daily Living) consists of 13 items scored between 0 and 4. The sum score was calculated as the sum of these 13 individual scores. The UPDRS Part III (motor subscale) consists of 27 items and sub items scored between 0 and 4. The sum score was calculated as sum of these 27 individual scores. The sum score of UPDRS Parts II and III is the sum of the corresponding single sum scores. A negative value indicates an improvement.
Time Frame Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and includes all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement.
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo Transdermal Patches

Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days.

Rotigotine Transdermal Patches

Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days.

Overall Number of Participants Analyzed 29 30
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-5.1  (11.7) -8.3  (11.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Rotigotine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.346
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model for the change from Baseline to the End of Treatment containing treatment and region as factors and Baseline value as a covariate.
Method of Estimation Estimation Parameter Least Square Mean
Estimated Value -2.82
Confidence Interval (2-Sided) 95%
-8.76 to 3.13
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.97
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline to the End of the Maintenance Period in the 7 Domain Scores of Classification of Pain in Parkinson's Disease
Hide Description

The classification of pain in Parkinson's disease scale classifies pain in the following domains: musculoskeletal pain (item 1), chronic pain (items 2 and 3), fluctuation related pain (items 4, 5 and 6), nocturnal pain (items 7 and 8), oro-facial pain (items 9, 10 and 11), discoloration; edema/swelling (items 12 and 13), and radicular pain (item 14). Severity of the pain is measured on a scale from none (0) to severe (3) and frequency is measured on a scale from never (0) to very frequent (4).

A score of a single item was calculated by multiplying severity with frequency. A domain score was calculated as the sum of every individual score related to the respective domain. A negative value indicates an improvement.

Time Frame Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and includes all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement.
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo Transdermal Patches

Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days.

Rotigotine Transdermal Patches

Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days.

Overall Number of Participants Analyzed 29 30
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Musculoskeletal Pain -1.4  (3.6) -1.5  (4.2)
Chronic Pain -3.1  (5.6) -0.7  (2.9)
Fluctuation-Related Pain -2.2  (4.6) -4.2  (6.8)
Nocturnal Pain -2.9  (6.1) -2.4  (5.3)
Oro-Facial Pain -0.4  (2.5) -0.6  (2.3)
Discoloration; Edema/Swelling -1.8  (4.9) -1.7  (3.4)
Radicular Pain -1.3  (3.8) -1.1  (3.7)
Time Frame Treatment Emergent Adverse Events were reported from Baseline up to the Safety Follow-up Visit (approximately during 25 weeks).
Adverse Event Reporting Description Adverse Events refer to the Safety Set (SS). The SS includes all randomized subjects who received at least 1 dose of study medication.
 
Arm/Group Title Placebo Rotigotine
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Placebo Transdermal Patches

Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days.

Rotigotine Transdermal Patches

Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days.

All-Cause Mortality
Placebo Rotigotine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Placebo Rotigotine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/33 (3.03%)      2/35 (5.71%)    
General disorders     
Oedema peripheral * 1  0/33 (0.00%)  0 1/35 (2.86%)  1
Injury, poisoning and procedural complications     
Hip fracture * 1  1/33 (3.03%)  1 0/35 (0.00%)  0
Nervous system disorders     
Cerebrovascular accident * 1  0/33 (0.00%)  0 1/35 (2.86%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDra 16.0
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   17/33 (51.52%)      20/35 (57.14%)    
Gastrointestinal disorders     
Diarrhoea * 1  2/33 (6.06%)  2 0/35 (0.00%)  0
Nausea * 1  2/33 (6.06%)  3 8/35 (22.86%)  11
General disorders     
Application site erythema * 1  0/33 (0.00%)  0 3/35 (8.57%)  3
Fatigue * 1  1/33 (3.03%)  1 2/35 (5.71%)  2
Infections and infestations     
Upper respiratory tract infection * 1  2/33 (6.06%)  2 1/35 (2.86%)  1
Urinary tract infection * 1  0/33 (0.00%)  0 2/35 (5.71%)  2
Injury, poisoning and procedural complications     
Fall * 1  0/33 (0.00%)  0 2/35 (5.71%)  3
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma * 1  2/33 (6.06%)  2 1/35 (2.86%)  1
Nervous system disorders     
Dyskinesia * 1  2/33 (6.06%)  2 2/35 (5.71%)  2
Hyperkinesia * 1  2/33 (6.06%)  2 0/35 (0.00%)  0
Headache * 1  4/33 (12.12%)  11 6/35 (17.14%)  7
Dizziness * 1  3/33 (9.09%)  3 3/35 (8.57%)  3
Psychiatric disorders     
Insomnia * 1  1/33 (3.03%)  1 3/35 (8.57%)  3
Skin and subcutaneous tissue disorders     
Rash * 1  2/33 (6.06%)  2 2/35 (5.71%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDra 16.0
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.
Results Point of Contact
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Name/Title: UCB Clinical Trial Call Center
Organization: UCB
Phone: +1 877 822 9493
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Responsible Party: UCB Pharma ( UCB BIOSCIENCES GmbH )
ClinicalTrials.gov Identifier: NCT01744496    
Other Study ID Numbers: PD0004
2012-002608-42 ( EudraCT Number )
First Submitted: December 5, 2012
First Posted: December 6, 2012
Results First Submitted: November 24, 2014
Results First Posted: December 2, 2014
Last Update Posted: May 1, 2015