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Trial record 1 of 1 for:    NCT01711866
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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

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ClinicalTrials.gov Identifier: NCT01711866
Recruitment Status : Completed
First Posted : October 22, 2012
Results First Posted : April 7, 2014
Last Update Posted : April 7, 2014
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES GmbH )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Advanced Idiopathic Parkinson's Disease
Intervention Drug: Rotigotine
Enrollment 87
Recruitment Details

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.

Pre-assignment Details  
Arm/Group Title Rotigotine
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 87
Completed 79
Not Completed 8
Reason Not Completed
Noncompliant             3
Withdrawal by Subject             3
Adverse Event             2
Arm/Group Title Rotigotine
Hide Arm/Group Description

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 Number of Baseline Participants 87
Hide Baseline Analysis Population Description
Baseline characteristics refer to the Safety Set. The Safety Set consists of all subjects who had at least one patch application.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 87 participants
59.5  (8.5)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants
<=18 years
0
   0.0%
Between 18 and 65 years
60
  69.0%
>=65 years
27
  31.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants
Female
47
  54.0%
Male
40
  46.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 87 participants
United States 6
Taiwan 9
Malaysia 1
Singapore 2
Korea, Republic of 69
1.Primary Outcome
Title Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period or Early Withdrawal Visit
Hide Description

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.
Time Frame Day 28 (Visit 5) of the 28 days Treatment Period or Early Withdrawal Visit
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rotigotine
Hide Arm/Group Description:

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 Number of Participants Analyzed 87
Measure Type: Number
Unit of Measure: participants
CGI Item 4 score of 1 58
CGI Item 4 score of 2 26
CGI Item 4 score of 3 3
CGI Item 4 score of 4 0
CGI Item 4 score of 3 or 4 3
2.Secondary Outcome
Title Patients Global Impressions of Change (PGIC) at the End of the Treatment Period or Early Withdrawal Visit
Hide Description

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.
Time Frame Day 28 (Visit 5) of the 28 days Treatment Period or Early Withdrawal Visit
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rotigotine
Hide Arm/Group Description:

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 Number of Participants Analyzed 84
Measure Type: Number
Unit of Measure: participants
PGIC category 1 5
PGIC category 2 17
PGIC category 3 30
PGIC category 4 18
PGIC category 5 10
PGIC category 6 3
PGIC category 7 1
PGIC category ≥ 5 14
PGIC category ≥ 6 4
Time Frame 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 Event Reporting Description 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.
 
Arm/Group Title Rotigotine
Hide Arm/Group Description

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.

All-Cause Mortality
Rotigotine
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Rotigotine
Affected / at Risk (%) # Events
Total   1/87 (1.15%)    
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Hepatocellular carcinoma * 1  1/87 (1.15%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rotigotine
Affected / at Risk (%) # Events
Total   30/87 (34.48%)    
General disorders   
Application site pruritus * 1  9/87 (10.34%)  9
Application site erythema * 1  6/87 (6.90%)  6
Nervous system disorders   
Dizziness * 1  6/87 (6.90%)  6
Dyskinesia * 1  6/87 (6.90%)  6
Skin and subcutaneous tissue disorders   
Erythema * 1  5/87 (5.75%)  5
Pruritus * 1  5/87 (5.75%)  5
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB Clinical Trial Call Center
Organization: UCB
Phone: +1 877 822 9493
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB BIOSCIENCES GmbH )
ClinicalTrials.gov Identifier: NCT01711866    
Other Study ID Numbers: PD0009
First Submitted: October 18, 2012
First Posted: October 22, 2012
Results First Submitted: February 25, 2014
Results First Posted: April 7, 2014
Last Update Posted: April 7, 2014