Trial Outcomes & Findings for A Phase 4, Open-label Study to Assess the Feasibility and Efficacy on Motor and Non-motor Symptoms of Switching From Pramipexole or Ropinirole to Rotigotine Transdermal Patch in Subjects With Advanced Idiopathic Parkinson's Disease (NCT NCT01711866)
NCT ID: NCT01711866
Last Updated: 2014-04-07
Results Overview
The CGI Item 4 was used to assess side effects. It ranges from 0 to 4 as follows: * 0 = Side effects not assessable * 1 = No side effects * 2 = Side effects do not significantly interfere with subject's functioning * 3 = Side effects significantly interfere with the subject's functioning * 4 = Side effects outweigh therapeutic efficacy.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
87 participants
Primary outcome timeframe
Day 28 (Visit 5) of the 28 days Treatment Period or Early Withdrawal Visit
Results posted on
2014-04-07
Participant Flow
This multicenter study started to enroll subjects in September 2012 in order to enroll 87 subjects in 5 countries. Participant Flow refers to the Safety Set (SS). SS consists of all subjects who were enrolled and had at least 1 patch applied during the Treatment Period.
Participant milestones
| Measure |
Rotigotine
First application of Rotigotine patch for 24 hours on Day 1, followed by application of a new patch each day of the Treatment Period.
* Subjects on lower doses switch from Pramipexole or Ropinirole to equivalence doses of Rotigotine on Day 1 of the 28 days Treatment Period. On Day 8 (Visit 3) the dose will be evaluated and potentially adjusted up to a maximum dose of 8 mg / 24 hours.
* Subjects on higher doses switch from the equivalent dose to 8 mg / 24 hours Rotigotine of Pramipexole or Ropinirole to 8 mg / 24 hours Rotigotine on Day 1 and the remainder of the dose of Pramipexole or Ropinirole is to be switched on Day 8 of the 28 days Treatment Period. On Day 15 (Visit 4) the dose will be evaluated and potentially adjusted up to a maximum dose of 16 mg / 24 hours.
Rotigotine: Rotigotine up to 16 mg / 24 hours, 4 weeks.
|
|---|---|
|
Overall Study
STARTED
|
87
|
|
Overall Study
COMPLETED
|
79
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Rotigotine
First application of Rotigotine patch for 24 hours on Day 1, followed by application of a new patch each day of the Treatment Period.
* Subjects on lower doses switch from Pramipexole or Ropinirole to equivalence doses of Rotigotine on Day 1 of the 28 days Treatment Period. On Day 8 (Visit 3) the dose will be evaluated and potentially adjusted up to a maximum dose of 8 mg / 24 hours.
* Subjects on higher doses switch from the equivalent dose to 8 mg / 24 hours Rotigotine of Pramipexole or Ropinirole to 8 mg / 24 hours Rotigotine on Day 1 and the remainder of the dose of Pramipexole or Ropinirole is to be switched on Day 8 of the 28 days Treatment Period. On Day 15 (Visit 4) the dose will be evaluated and potentially adjusted up to a maximum dose of 16 mg / 24 hours.
Rotigotine: Rotigotine up to 16 mg / 24 hours, 4 weeks.
|
|---|---|
|
Overall Study
Noncompliant
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Adverse Event
|
2
|
Baseline Characteristics
A Phase 4, Open-label Study to Assess the Feasibility and Efficacy on Motor and Non-motor Symptoms of Switching From Pramipexole or Ropinirole to Rotigotine Transdermal Patch in Subjects With Advanced Idiopathic Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Rotigotine
n=87 Participants
First application of Rotigotine patch for 24 hours on Day 1, followed by application of a new patch each day of the Treatment Period.
* Subjects on lower doses switch from Pramipexole or Ropinirole to equivalence doses of Rotigotine on Day 1 of the 28 days Treatment Period. On Day 8 (Visit 3) the dose will be evaluated and potentially adjusted up to a maximum dose of 8 mg / 24 hours.
* Subjects on higher doses switch from the equivalent dose to 8 mg / 24 hours Rotigotine of Pramipexole or Ropinirole to 8 mg / 24 hours Rotigotine on Day 1 and the remainder of the dose of Pramipexole or Ropinirole is to be switched on Day 8 of the 28 days Treatment Period. On Day 15 (Visit 4) the dose will be evaluated and potentially adjusted up to a maximum dose of 16 mg / 24 hours.
Rotigotine: Rotigotine up to 16 mg / 24 hours, 4 weeks.
|
|---|---|
|
Age, Continuous
|
59.5 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
60 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Malaysia
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Singapore
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
69 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 28 (Visit 5) of the 28 days Treatment Period or Early Withdrawal VisitPopulation: All 87 subjects of the Safety Set are included in the analysis of this outcome measure. Last Observation Carried Forward (LOCF) was used as a method of imputation for missing observations.
The CGI Item 4 was used to assess side effects. It ranges from 0 to 4 as follows: * 0 = Side effects not assessable * 1 = No side effects * 2 = Side effects do not significantly interfere with subject's functioning * 3 = Side effects significantly interfere with the subject's functioning * 4 = Side effects outweigh therapeutic efficacy.
Outcome measures
| Measure |
Rotigotine
n=87 Participants
First application of Rotigotine patch for 24 hours on Day 1, followed by application of a new patch each day of the Treatment Period.
* Subjects on lower doses switch from Pramipexole or Ropinirole to equivalence doses of Rotigotine on Day 1 of the 28 days Treatment Period. On Day 8 (Visit 3) the dose will be evaluated and potentially adjusted up to a maximum dose of 8 mg / 24 hours.
* Subjects on higher doses switch from the equivalent dose to 8 mg / 24 hours Rotigotine of Pramipexole or Ropinirole to 8 mg / 24 hours Rotigotine on Day 1 and the remainder of the dose of Pramipexole or Ropinirole is to be switched on Day 8 of the 28 days Treatment Period. On Day 15 (Visit 4) the dose will be evaluated and potentially adjusted up to a maximum dose of 16 mg / 24 hours.
Rotigotine: Rotigotine up to 16 mg / 24 hours, 4 weeks.
|
|---|---|
|
Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period or Early Withdrawal Visit
CGI Item 4 score of 1
|
58 participants
|
|
Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period or Early Withdrawal Visit
CGI Item 4 score of 2
|
26 participants
|
|
Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period or Early Withdrawal Visit
CGI Item 4 score of 3
|
3 participants
|
|
Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period or Early Withdrawal Visit
CGI Item 4 score of 4
|
0 participants
|
|
Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period or Early Withdrawal Visit
CGI Item 4 score of 3 or 4
|
3 participants
|
SECONDARY outcome
Timeframe: Day 28 (Visit 5) of the 28 days Treatment Period or Early Withdrawal VisitPopulation: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) as a method of imputation for missing observations. FAS includes all subjects with at least 1 patch application during Treatment Period, and with an evaluable UPDRS Part III total score at Baseline and at least 1 valid value after Baseline to Day 35.
The PGIC is a 7-point categorical rating scale in which the subject rates the changes in functioning over time as follows: * 1 = Very much improved * 2 = Much improved * 3 = Minimally improved * 4 = No change * 5 = Minimally worse * 6 = Much worse * 7 = Very much worse.
Outcome measures
| Measure |
Rotigotine
n=84 Participants
First application of Rotigotine patch for 24 hours on Day 1, followed by application of a new patch each day of the Treatment Period.
* Subjects on lower doses switch from Pramipexole or Ropinirole to equivalence doses of Rotigotine on Day 1 of the 28 days Treatment Period. On Day 8 (Visit 3) the dose will be evaluated and potentially adjusted up to a maximum dose of 8 mg / 24 hours.
* Subjects on higher doses switch from the equivalent dose to 8 mg / 24 hours Rotigotine of Pramipexole or Ropinirole to 8 mg / 24 hours Rotigotine on Day 1 and the remainder of the dose of Pramipexole or Ropinirole is to be switched on Day 8 of the 28 days Treatment Period. On Day 15 (Visit 4) the dose will be evaluated and potentially adjusted up to a maximum dose of 16 mg / 24 hours.
Rotigotine: Rotigotine up to 16 mg / 24 hours, 4 weeks.
|
|---|---|
|
Patients Global Impressions of Change (PGIC) at the End of the Treatment Period or Early Withdrawal Visit
PGIC category 1
|
5 participants
|
|
Patients Global Impressions of Change (PGIC) at the End of the Treatment Period or Early Withdrawal Visit
PGIC category 2
|
17 participants
|
|
Patients Global Impressions of Change (PGIC) at the End of the Treatment Period or Early Withdrawal Visit
PGIC category 3
|
30 participants
|
|
Patients Global Impressions of Change (PGIC) at the End of the Treatment Period or Early Withdrawal Visit
PGIC category 4
|
18 participants
|
|
Patients Global Impressions of Change (PGIC) at the End of the Treatment Period or Early Withdrawal Visit
PGIC category 5
|
10 participants
|
|
Patients Global Impressions of Change (PGIC) at the End of the Treatment Period or Early Withdrawal Visit
PGIC category 6
|
3 participants
|
|
Patients Global Impressions of Change (PGIC) at the End of the Treatment Period or Early Withdrawal Visit
PGIC category 7
|
1 participants
|
|
Patients Global Impressions of Change (PGIC) at the End of the Treatment Period or Early Withdrawal Visit
PGIC category ≥ 5
|
14 participants
|
|
Patients Global Impressions of Change (PGIC) at the End of the Treatment Period or Early Withdrawal Visit
PGIC category ≥ 6
|
4 participants
|
Adverse Events
Rotigotine
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rotigotine
n=87 participants at risk
First application of Rotigotine patch for 24 hours on Day 1, followed by application of a new patch each day of the Treatment Period.
* Subjects on lower doses switch from Pramipexole or Ropinirole to equivalence doses of Rotigotine on Day 1 of the 28 days Treatment Period. On Day 8 (Visit 3) the dose will be evaluated and potentially adjusted up to a maximum dose of 8 mg / 24 hours.
* Subjects on higher doses switch from the equivalent dose to 8 mg / 24 hours Rotigotine of Pramipexole or Ropinirole to 8 mg / 24 hours Rotigotine on Day 1 and the remainder of the dose of Pramipexole or Ropinirole is to be switched on Day 8 of the 28 days Treatment Period. On Day 15 (Visit 4) the dose will be evaluated and potentially adjusted up to a maximum dose of 16 mg / 24 hours.
Rotigotine: Rotigotine up to 16 mg / 24 hours, 4 weeks.
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
1.1%
1/87 • Number of events 1 • Adverse Events (AEs) were collected over the whole study duration from the Screening Period (Day -28 to Day -1) to the Safety Follow-up Visit (up to Day 54).
Adverse Events refer to the Saftey Set. Safety Set consists of all subjects who were enrolled and had at least 1 patch applied during the Treatment Period.
|
Other adverse events
| Measure |
Rotigotine
n=87 participants at risk
First application of Rotigotine patch for 24 hours on Day 1, followed by application of a new patch each day of the Treatment Period.
* Subjects on lower doses switch from Pramipexole or Ropinirole to equivalence doses of Rotigotine on Day 1 of the 28 days Treatment Period. On Day 8 (Visit 3) the dose will be evaluated and potentially adjusted up to a maximum dose of 8 mg / 24 hours.
* Subjects on higher doses switch from the equivalent dose to 8 mg / 24 hours Rotigotine of Pramipexole or Ropinirole to 8 mg / 24 hours Rotigotine on Day 1 and the remainder of the dose of Pramipexole or Ropinirole is to be switched on Day 8 of the 28 days Treatment Period. On Day 15 (Visit 4) the dose will be evaluated and potentially adjusted up to a maximum dose of 16 mg / 24 hours.
Rotigotine: Rotigotine up to 16 mg / 24 hours, 4 weeks.
|
|---|---|
|
General disorders
Application site pruritus
|
10.3%
9/87 • Number of events 9 • Adverse Events (AEs) were collected over the whole study duration from the Screening Period (Day -28 to Day -1) to the Safety Follow-up Visit (up to Day 54).
Adverse Events refer to the Saftey Set. Safety Set consists of all subjects who were enrolled and had at least 1 patch applied during the Treatment Period.
|
|
General disorders
Application site erythema
|
6.9%
6/87 • Number of events 6 • Adverse Events (AEs) were collected over the whole study duration from the Screening Period (Day -28 to Day -1) to the Safety Follow-up Visit (up to Day 54).
Adverse Events refer to the Saftey Set. Safety Set consists of all subjects who were enrolled and had at least 1 patch applied during the Treatment Period.
|
|
Nervous system disorders
Dizziness
|
6.9%
6/87 • Number of events 6 • Adverse Events (AEs) were collected over the whole study duration from the Screening Period (Day -28 to Day -1) to the Safety Follow-up Visit (up to Day 54).
Adverse Events refer to the Saftey Set. Safety Set consists of all subjects who were enrolled and had at least 1 patch applied during the Treatment Period.
|
|
Nervous system disorders
Dyskinesia
|
6.9%
6/87 • Number of events 6 • Adverse Events (AEs) were collected over the whole study duration from the Screening Period (Day -28 to Day -1) to the Safety Follow-up Visit (up to Day 54).
Adverse Events refer to the Saftey Set. Safety Set consists of all subjects who were enrolled and had at least 1 patch applied during the Treatment Period.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.7%
5/87 • Number of events 5 • Adverse Events (AEs) were collected over the whole study duration from the Screening Period (Day -28 to Day -1) to the Safety Follow-up Visit (up to Day 54).
Adverse Events refer to the Saftey Set. Safety Set consists of all subjects who were enrolled and had at least 1 patch applied during the Treatment Period.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.7%
5/87 • Number of events 5 • Adverse Events (AEs) were collected over the whole study duration from the Screening Period (Day -28 to Day -1) to the Safety Follow-up Visit (up to Day 54).
Adverse Events refer to the Saftey Set. Safety Set consists of all subjects who were enrolled and had at least 1 patch applied during the Treatment Period.
|
Additional Information
UCB Clinical Trial Call Center
UCB
Phone: +1 877 822 9493
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60