Trial Outcomes & Findings for Rotigotine Versus Placebo to Evaluate the Efficacy on Depressive Symptoms in Idiopathic Parkinson's Disease Patients (NCT NCT01523301)
NCT ID: NCT01523301
Last Updated: 2015-12-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
380 participants
Primary outcome timeframe
From Baseline (Week 0) to end of Maintenance Period (up to Week 15)
Results posted on
2015-12-18
Participant Flow
This double-blind, randomized, multicenter, placebo-controlled, in-Patient study started recruiting in April 2012.
Participant flow refers to the Randomized Set (RS), consisting of all randomized subjects.
Participant milestones
| Measure |
Rotigotine
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
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.
|
|---|---|---|
|
Overall Study
STARTED
|
184
|
196
|
|
Overall Study
COMPLETED
|
149
|
164
|
|
Overall Study
NOT COMPLETED
|
35
|
32
|
Reasons for withdrawal
| Measure |
Rotigotine
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
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
25
|
16
|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
|
Overall Study
Protocol Violation
|
3
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
6
|
8
|
|
Overall Study
Other Reason
|
0
|
2
|
Baseline Characteristics
Rotigotine Versus Placebo to Evaluate the Efficacy on Depressive Symptoms in Idiopathic Parkinson's Disease Patients
Baseline characteristics by cohort
| Measure |
Rotigotine
n=184 Participants
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
n=196 Participants
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.
|
Total Title
n=380 Participants
|
|---|---|---|---|
|
Age, Continuous
|
65.6 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
64.9 years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
65.2 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
|
Age, Customized
<=18 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Age, Customized
>18-<65 years
|
76 participants
n=5 Participants
|
88 participants
n=7 Participants
|
164 participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
108 participants
n=5 Participants
|
108 participants
n=7 Participants
|
216 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
96 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
218 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
88 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
162 Participants
n=5 Participants
|
|
Weight
|
61.54 kg
STANDARD_DEVIATION 9.68 • n=5 Participants
|
62.24 kg
STANDARD_DEVIATION 9.84 • n=7 Participants
|
61.90 kg
STANDARD_DEVIATION 9.76 • n=5 Participants
|
|
Height
|
160.04 cm
STANDARD_DEVIATION 8.41 • n=5 Participants
|
159.17 cm
STANDARD_DEVIATION 8.14 • n=7 Participants
|
159.59 cm
STANDARD_DEVIATION 8.27 • n=5 Participants
|
PRIMARY outcome
Timeframe: From Baseline (Week 0) to end of Maintenance Period (up to Week 15)Population: 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.
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.
Outcome measures
| Measure |
Efficacy Evaluable Set (Rotigotine Treated Subjects)
n=120 Participants
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.
|
Efficacy Evaluable Set (Placebo Treated Subjects)
n=131 Participants
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.
|
|---|---|---|
|
Change From Baseline to the End of Maintenance Period in the Score of the Hamilton Depression Scale (HAM-D)
|
-4.79 units on a scale
Interval -5.87 to -3.71
|
-3.68 units on a scale
Interval -4.68 to -2.67
|
SECONDARY outcome
Timeframe: From Baseline (Week 0) to end of Maintenance Period (up to Week 15)Population: 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.
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.
Outcome measures
| Measure |
Efficacy Evaluable Set (Rotigotine Treated Subjects)
n=120 Participants
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.
|
Efficacy Evaluable Set (Placebo Treated Subjects)
n=131 Participants
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.
|
|---|---|---|
|
Change From Baseline to the End of Maintenance Period in the Score of Beck Depression Inventory (BDI-II)
|
-5.87 units on a scale
Interval -7.39 to -4.34
|
-4.68 units on a scale
Interval -6.11 to -3.26
|
SECONDARY outcome
Timeframe: From Baseline (Week 0) to end of Maintenance Period (up to Week 15)Population: 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.
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).
Outcome measures
| Measure |
Efficacy Evaluable Set (Rotigotine Treated Subjects)
n=120 Participants
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.
|
Efficacy Evaluable Set (Placebo Treated Subjects)
n=131 Participants
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.
|
|---|---|---|
|
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)
|
-1.13 units on a scale
Interval -1.76 to -0.5
|
-0.10 units on a scale
Interval -0.69 to 0.49
|
SECONDARY outcome
Timeframe: From Baseline (Week 0) to end of Maintenance Period (up to Week 15)Population: 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.
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).
Outcome measures
| Measure |
Efficacy Evaluable Set (Rotigotine Treated Subjects)
n=120 Participants
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.
|
Efficacy Evaluable Set (Placebo Treated Subjects)
n=131 Participants
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.
|
|---|---|---|
|
Change From Baseline to the End of Maintenance Period in the Score of Unified Parkinson's Disease Rating Scale (UPDRS) Part III (Motor Subscale)
|
-3.07 units on a scale
Interval -4.28 to -1.86
|
-1.65 units on a scale
Interval -2.78 to -0.52
|
SECONDARY outcome
Timeframe: From Baseline (Week 0) to end of Maintenance Period (up to Week 15)Population: 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.
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).
Outcome measures
| Measure |
Efficacy Evaluable Set (Rotigotine Treated Subjects)
n=120 Participants
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.
|
Efficacy Evaluable Set (Placebo Treated Subjects)
n=131 Participants
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.
|
|---|---|---|
|
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)
|
-4.20 units on a scale
Interval -5.79 to -2.62
|
-1.81 units on a scale
Interval -3.29 to -0.33
|
SECONDARY outcome
Timeframe: From Baseline (Week 0) to end of Maintenance Period (up to Week 15)Population: 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.
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.
Outcome measures
| Measure |
Efficacy Evaluable Set (Rotigotine Treated Subjects)
n=120 Participants
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.
|
Efficacy Evaluable Set (Placebo Treated Subjects)
n=131 Participants
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.
|
|---|---|---|
|
Change From Baseline to the End of Maintenance Period in the Score of Apathy Scale (AS)
|
-1.93 units on a scale
Interval -2.83 to -1.04
|
-0.67 units on a scale
Interval -1.5 to 0.17
|
SECONDARY outcome
Timeframe: From Baseline (Week 0) to end of Maintenance Period (up to Week 15)Population: 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.
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.
Outcome measures
| Measure |
Efficacy Evaluable Set (Rotigotine Treated Subjects)
n=120 Participants
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.
|
Efficacy Evaluable Set (Placebo Treated Subjects)
n=131 Participants
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.
|
|---|---|---|
|
Change From Baseline to the End of Maintenance Period in the Score of Snaith-Hamilton Pleasure Scale (SHAPS)
|
-0.82 units on a scale
Interval -1.28 to -0.37
|
-0.60 units on a scale
Interval -1.03 to -0.17
|
Adverse Events
Rotigotine
Serious events: 6 serious events
Other events: 112 other events
Deaths: 0 deaths
Placebo
Serious events: 14 serious events
Other events: 91 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rotigotine
n=184 participants at risk
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
n=196 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/184 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
0.51%
1/196 • Number of events 1 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Congenital, familial and genetic disorders
Spondylolisthesis
|
0.54%
1/184 • Number of events 1 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/196 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/184 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
0.51%
1/196 • Number of events 1 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
|
General disorders
Chest discomfort
|
0.00%
0/184 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
0.51%
1/196 • Number of events 4 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Hepatitis
|
0.54%
1/184 • Number of events 1 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/196 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Jaundice
|
0.54%
1/184 • Number of events 1 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/196 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/184 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
0.51%
1/196 • Number of events 1 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Immune system disorders
Kidney transplant rejection
|
0.54%
1/184 • Number of events 1 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/196 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/184 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
0.51%
1/196 • Number of events 1 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/184 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
0.51%
1/196 • Number of events 1 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/184 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
1.0%
2/196 • Number of events 2 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/184 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
0.51%
1/196 • Number of events 2 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/184 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
0.51%
1/196 • Number of events 1 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.54%
1/184 • Number of events 1 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/196 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.54%
1/184 • Number of events 1 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/196 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.54%
1/184 • Number of events 1 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/196 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/184 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
0.51%
1/196 • Number of events 1 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/184 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
0.51%
1/196 • Number of events 1 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/184 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
0.51%
1/196 • Number of events 1 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma stage IV
|
0.00%
0/184 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
0.51%
1/196 • Number of events 1 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Nervous system disorders
Dizziness
|
0.54%
1/184 • Number of events 1 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/196 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Nervous system disorders
Tremor
|
0.54%
1/184 • Number of events 1 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/196 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Nervous system disorders
Headache
|
0.00%
0/184 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
0.51%
1/196 • Number of events 1 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/184 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
0.51%
1/196 • Number of events 1 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/184 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
0.51%
1/196 • Number of events 1 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
Other adverse events
| Measure |
Rotigotine
n=184 participants at risk
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
n=196 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
22.8%
42/184 • Number of events 52 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
7.7%
15/196 • Number of events 16 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
13/184 • Number of events 14 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
1.0%
2/196 • Number of events 2 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
5.4%
10/184 • Number of events 12 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
5.1%
10/196 • Number of events 10 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
|
General disorders
Application site pruritus
|
10.3%
19/184 • Number of events 20 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
5.1%
10/196 • Number of events 12 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
|
General disorders
Application site erythema
|
6.0%
11/184 • Number of events 11 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
2.6%
5/196 • Number of events 6 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
|
General disorders
Asthenia
|
2.7%
5/184 • Number of events 5 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
5.6%
11/196 • Number of events 13 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
3.8%
7/184 • Number of events 8 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
6.6%
13/196 • Number of events 15 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Nervous system disorders
Dizziness
|
15.2%
28/184 • Number of events 31 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
12.8%
25/196 • Number of events 27 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Nervous system disorders
Headache
|
10.3%
19/184 • Number of events 22 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
10.2%
20/196 • Number of events 23 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Suicidal ideation
|
11.4%
21/184 • Number of events 25 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
11.2%
22/196 • Number of events 25 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Insomnia
|
7.1%
13/184 • Number of events 13 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
3.1%
6/196 • Number of events 7 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.5%
12/184 • Number of events 12 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
1.0%
2/196 • Number of events 3 • Treatment-emergent Adverse Events (TEAE) were collected during the study, which began in April 2012 and concluded in October 2014.
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who received at least 1 dose of study medication.
|
Additional Information
Study Director
UCB
Phone: +1877 822 9493
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER