Clinical Trial Results:
A Multicenter, Multinational, Double-Blind, Placebo-Controlled, 2-Arm Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain
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Summary
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EudraCT number |
2012-002608-42 |
Trial protocol |
DE GB HU SK |
Global end of trial date |
30 Jan 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
30 Jun 2016
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First version publication date |
25 Apr 2015
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
PD0004
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01744496 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
UCB BIOSCIENCES GmbH
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Sponsor organisation address |
Alfred-Nobel-Str. 10, Monheim, Germany, 40789
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Public contact |
Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, 0049 2173 48 15 15, clinicaltrials@ucb.com
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Scientific contact |
Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, 0049 2173 48 15 15, clinicaltrials@ucb.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
07 May 2014
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
30 Jan 2014
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To assess the effects of Rotigotine over placebo on improvement of Parkinson’s disease associated chronic pain in subjects with advanced-stage Parkinson’s disease experiencing Parkinson’s disease associated chronic pain.
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Protection of trial subjects |
Close monitoring of subjects safety status, including checks of mental health e.g. by CSSR-S questionnaire.
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Background therapy |
Not applicable | ||
Evidence for comparator |
Not applicable | ||
Actual start date of recruitment |
19 Nov 2012
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Germany: 2
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Country: Number of subjects enrolled |
Poland: 19
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Country: Number of subjects enrolled |
United States: 31
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Country: Number of subjects enrolled |
Slovakia: 16
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Worldwide total number of subjects |
68
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EEA total number of subjects |
37
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
27
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From 65 to 84 years |
40
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85 years and over |
1
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Recruitment
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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. | ||||||||||||||||||||||||||||||||||||
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Pre-assignment
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Screening details |
The Participant Flow population refers to the Randomized Set (RS). The RS includes all subjects who were randomized. | ||||||||||||||||||||||||||||||||||||
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Period 1
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Period 1 title |
Overall study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator, Assessor | ||||||||||||||||||||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Placebo | ||||||||||||||||||||||||||||||||||||
Arm description |
Placebo Transdermal PatchesPlacebo: 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. | ||||||||||||||||||||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Transdermal patch
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Routes of administration |
Transdermal use
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Dosage and administration details |
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.
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Arm title
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Rotigotine | ||||||||||||||||||||||||||||||||||||
Arm description |
Rotigotine Transdermal PatchesRotigotine: 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. | ||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Rotigotine
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Investigational medicinal product code |
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Other name |
Neupro
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Pharmaceutical forms |
Transdermal patch
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Routes of administration |
Transdermal use
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Dosage and administration details |
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.
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Baseline characteristics reporting groups
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Reporting group title |
Placebo
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Reporting group description |
Placebo Transdermal PatchesPlacebo: 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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Rotigotine
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Reporting group description |
Rotigotine Transdermal PatchesRotigotine: 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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Placebo
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Reporting group description |
Placebo Transdermal PatchesPlacebo: 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. | ||
Reporting group title |
Rotigotine
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Reporting group description |
Rotigotine Transdermal PatchesRotigotine: 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. | ||
Subject analysis set title |
FAS (Placebo treated subjects)
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
The Full Analysis Set 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.
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Subject analysis set title |
FAS (Rotigotine treated subjects)
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
The Full Analysis Set 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.
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End point title |
Change from Baseline to the End of the Maintenance Period in pain severity assessed using an 11-point Likert Pain Scale | |||||||||||||||
End point 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.
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End point type |
Primary
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End point timeframe |
Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after an up to 7 weeks Titration Period)
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| Notes [1] - Full Analysis Set (FAS) [2] - Full Analysis Set (FAS) |
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Statistical analysis title |
Statistical Analysis 1 | |||||||||||||||
Statistical analysis description |
ANCOVA model for the change from Baseline to the End of Treatment containing treatment and region as factors and Baseline value as a covariate.
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Comparison groups |
Placebo v Rotigotine
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Number of subjects included in analysis |
60
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||
P-value |
= 0.172 | |||||||||||||||
Method |
ANCOVA | |||||||||||||||
Parameter type |
Least Square Mean | |||||||||||||||
Point estimate |
-0.76
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Confidence interval |
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level |
95% | |||||||||||||||
sides |
2-sided
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lower limit |
-1.87 | |||||||||||||||
upper limit |
0.34 | |||||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
0.55
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End point title |
Percentage of Responders at the End of the Maintenance Period | |||||||||||||||
End point 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).
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End point type |
Secondary
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End point timeframe |
Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)
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| Notes [3] - Full Analysis Set (FAS) [4] - Full Analysis Set (FAS) |
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| No statistical analyses for this end point | ||||||||||||||||
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End point 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) | |||||||||||||||
End point 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.
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End point type |
Secondary
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End point timeframe |
Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)
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| Notes [5] - Full Analysis Set (FAS) [6] - Full Analysis Set (FAS) |
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Statistical analysis title |
Statistical Analysis 1 | |||||||||||||||
Statistical analysis description |
ANCOVA model for the change from Baseline to the End of Treatment containing treatment and region as factors and Baseline value as a covariate.
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Comparison groups |
Placebo v Rotigotine
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Number of subjects included in analysis |
59
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||
P-value |
= 0.038 | |||||||||||||||
Method |
ANCOVA | |||||||||||||||
Parameter type |
Least Square Mean | |||||||||||||||
Point estimate |
-8.01
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Confidence interval |
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level |
95% | |||||||||||||||
sides |
2-sided
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lower limit |
-15.56 | |||||||||||||||
upper limit |
-0.46 | |||||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
3.77
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End point 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) | |||||||||||||||
End point 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.
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End point type |
Secondary
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End point timeframe |
Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)
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| Notes [7] - Full Analysis Set (FAS) [8] - Full Analysis Set (FAS) |
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Statistical analysis title |
Statistical Analysis 1 | |||||||||||||||
Statistical analysis description |
ANCOVA model for the change from Baseline to the End of Treatment containing treatment and region as factors and Baseline value as a covariate.
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Comparison groups |
Placebo v Rotigotine
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Number of subjects included in analysis |
56
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||
P-value |
= 0.247 | |||||||||||||||
Method |
ANCOVA | |||||||||||||||
Parameter type |
Least Square Mean | |||||||||||||||
Point estimate |
-1.02
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Confidence interval |
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level |
95% | |||||||||||||||
sides |
2-sided
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lower limit |
-2.76 | |||||||||||||||
upper limit |
0.73 | |||||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
0.87
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End point 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) | |||||||||||||||
End point 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.
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End point type |
Secondary
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End point timeframe |
Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)
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| Notes [9] - Full Analysis Set (FAS) [10] - Full Analysis Set (FAS) |
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Statistical analysis title |
Statistical Analysis 1 | |||||||||||||||
Statistical analysis description |
ANCOVA model for the change from Baseline to the End of Treatment containing treatment and region as factors and Baseline value as a covariate.
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Comparison groups |
Placebo v Rotigotine
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Number of subjects included in analysis |
56
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||
P-value |
= 0.371 | |||||||||||||||
Method |
ANCOVA | |||||||||||||||
Parameter type |
Least Square Mean | |||||||||||||||
Point estimate |
-0.58
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Confidence interval |
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level |
95% | |||||||||||||||
sides |
2-sided
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lower limit |
-1.85 | |||||||||||||||
upper limit |
0.7 | |||||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
0.64
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End point 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) | |||||||||||||||
End point 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.
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End point type |
Secondary
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End point timeframe |
Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)
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| Notes [11] - Full Analysis Set (FAS) [12] - Full Analysis Set (FAS) |
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Statistical analysis title |
Statistical Analysis 1 | |||||||||||||||
Statistical analysis description |
ANCOVA model for the change from Baseline to the End of Treatment containing treatment and region as factors and Baseline value as a covariate.
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Comparison groups |
Placebo v Rotigotine
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Number of subjects included in analysis |
59
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||
P-value |
= 0.346 | |||||||||||||||
Method |
ANCOVA | |||||||||||||||
Parameter type |
Least Square Mean | |||||||||||||||
Point estimate |
-2.82
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Confidence interval |
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level |
95% | |||||||||||||||
sides |
2-sided
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lower limit |
-8.76 | |||||||||||||||
upper limit |
3.13 | |||||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
2.97
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End point title |
Change from Baseline to the End of the Maintenance Period in the 7 domain scores of Classification of Pain in Parkinson's Disease | |||||||||||||||||||||||||||||||||
End point 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.
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End point type |
Secondary
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End point timeframe |
Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)
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| Notes [13] - Full Analysis Set (FAS) [14] - Full Analysis Set (FAS) |
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Treatment Emergent Adverse Events were reported from Baseline up to the Safety Follow-up Visit (approximately during 25 weeks).
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Adverse event reporting additional description |
Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all randomized subjects who received at least 1 dose of study medication.
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Assessment type |
Non-systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
16.0
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Reporting groups
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Reporting group title |
Placebo
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Reporting 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. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Rotigotine
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Reporting group description |
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. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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22 Jul 2013 |
- The study design was changed to a hypothesis-generating pilot study
- The number of subjects was reduced. Subject enrollment had to continue until approximately 64 subjects were randomized or until the end of Jul 2013 (whichever occurred first)
- The study location was changed from being conducted globally to being conducted in only Europe and the USA
- Additionally some administrative information was updated |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
