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Trial record 15 of 27 for:    PDSS2

A Phase 3b, Open-Label, Safety and Efficacy Study of Rotigotine as Add-On Therapy With Low Doses of Pramipexole or Ropinirole in Patients With Advanced Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT01723904
Recruitment Status : Completed
First Posted : November 8, 2012
Results First Posted : June 3, 2014
Last Update Posted : June 3, 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 Parkinson's Disease
Intervention Drug: Rotigotine
Enrollment 90
Recruitment Details This multicenter study started to enroll subjects in 5 countries in October 2012.
Pre-assignment Details 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.
Arm/Group Title Rotigotine
Hide Arm/Group Description

- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.

Duration of the Titration Period: Between 1 week and 5 weeks.

- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.

Duration of the Maintenance Period: Between 3 weeks and 7 weeks.

Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours.

Period Title: Overall Study
Started 90
Completed 79
Not Completed 11
Reason Not Completed
Noncompliant             3
Adverse Event             5
Unable to follow protocol/ judged by inv             3
Arm/Group Title Rotigotine
Hide Arm/Group Description

- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.

Duration of the Titration Period: Between 1 week and 5 weeks.

- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.

Duration of the Maintenance Period: Between 3 weeks and 7 weeks.

Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours.

Overall Number of Baseline Participants 90
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 90 participants
61.3  (9.3)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 90 participants
< 65 years 57
>= 65 years 33
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants
Female
43
  47.8%
Male
47
  52.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 90 participants
Taiwan 8
Malaysia 6
Singapore 4
Australia 6
Korea, Republic of 66
1.Primary Outcome
Title Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period
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 Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)
Hide Outcome Measure Data
Hide Analysis Population Description
From the 90 subjects in the Safatey Set, 89 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:

- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.

Duration of the Titration Period: Between 1 week and 5 weeks.

- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.

Duration of the Maintenance Period: Between 3 weeks and 7 weeks.

Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours.

Overall Number of Participants Analyzed 89
Measure Type: Number
Unit of Measure: participants
CGI Item 4 score of 1 61
CGI Item 4 score of 2 22
CGI Item 4 score of 3 3
CGI Item 4 score of 4 3
CGI Item 4 score of 3 or 4 6
2.Primary Outcome
Title Change From Baseline to the End of the Treatment Period in the Unified Parkinson’s Disease Rating Scale (UPDRS) Part III (“on” State) Total Score
Hide Description

The Unified Parkinson´s Disease Rating Scale Part III is an accepted and validated scale for the assessment of motor function in Parkinson´s disease. Each of the 27 sub-items in the UPDRS III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. The total scores therefore ranges from 0 to 108.

A negative value in Change from Baseline to Week 8 indicates an improvement in motor functions from Baseline.

Time Frame From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)
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 64.
Arm/Group Title Rotigotine
Hide Arm/Group Description:

- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.

Duration of the Titration Period: Between 1 week and 5 weeks.

- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.

Duration of the Maintenance Period: Between 3 weeks and 7 weeks.

Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours.

Overall Number of Participants Analyzed 89
Mean (Standard Deviation)
Unit of Measure: units on a scale
-5.3  (8.3)
3.Primary Outcome
Title Change From Baseline to the End of the Treatment Period in the Unified Parkinson’s Disease Rating Scale (UPDRS) Part II (Average of “on” and “Off” State) Total Score
Hide Description

UPDRS Part II measures 'Activities in Daily Living'. The total score ranges from 0 (Best score possible) to 52 (Worst score possible).

UPDRS Part II total score (average of "on" and "off" state) is the average of UPDRS Part II total score (“on” state) and Part II total score (“off” state).

A negative value in Change from Baseline to Week 8 indicates an improvement in activities in daily living from Baseline.

Time Frame From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)
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 64.
Arm/Group Title Rotigotine
Hide Arm/Group Description:

- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.

Duration of the Titration Period: Between 1 week and 5 weeks.

- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.

Duration of the Maintenance Period: Between 3 weeks and 7 weeks.

Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours.

Overall Number of Participants Analyzed 85
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.5  (3.8)
4.Primary Outcome
Title Change From Baseline to the End of the Treatment Period in Absolute Time Spent “Off”
Hide Description

Absolute time spent "off" is measured in hours per day. A negative value in Change from Baseline to Week 8 indicates that the time spent "off" decreased from Baseline and therefore indicates an improvement from Baseline.

Only subjects with time spent "off" at Baseline (subset of the Full Analysis Set (FAS)) are included in the analysis of this outcome measure.

Time Frame From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with time spent "off" at Baseline in the 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 64.
Arm/Group Title Rotigotine
Hide Arm/Group Description:

- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.

Duration of the Titration Period: Between 1 week and 5 weeks.

- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.

Duration of the Maintenance Period: Between 3 weeks and 7 weeks.

Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours.

Overall Number of Participants Analyzed 80
Mean (Standard Deviation)
Unit of Measure: hours/day
-2.1  (2.9)
5.Secondary Outcome
Title Change From Baseline to the End of the Treatment Period in Time Spent “on” Without Troublesome Dyskinesia
Hide Description Absolute time spent "on" without troublesome dyskinesia is measured in hours per day. A positive value in Change from Baseline to Week 8 indicates that the time spent "on" without troublesome dyskinesia increased from Baseline and therefore indicates an improvement from Baseline.
Time Frame From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)
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 64.
Arm/Group Title Rotigotine
Hide Arm/Group Description:

- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.

Duration of the Titration Period: Between 1 week and 5 weeks.

- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.

Duration of the Maintenance Period: Between 3 weeks and 7 weeks.

Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours.

Overall Number of Participants Analyzed 84
Mean (Standard Deviation)
Unit of Measure: hours/day
1.9  (3.1)
6.Secondary Outcome
Title Change From Baseline to the End of Treatment Period in Parkinson’s Disease Sleep Scale 2 (PDSS-2) Total Score
Hide Description

The Parkinson´s Disease Sleep Scale (PDSS) is a questionnaire with 15 questions to assess sleep disturbance and nocturnal disability in Parkinson´s disease. The item- scores can range between 0= never and 4= very often. The PDSS score is a sum score of all 15 questions.

A negative value in Change from Baseline to Week 8 indicates an improvement from Baseline.

Time Frame From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)
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 64.
Arm/Group Title Rotigotine
Hide Arm/Group Description:

- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.

Duration of the Titration Period: Between 1 week and 5 weeks.

- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.

Duration of the Maintenance Period: Between 3 weeks and 7 weeks.

Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours.

Overall Number of Participants Analyzed 89
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.2  (7.5)
7.Secondary Outcome
Title Change From Baseline to the End of Treatment Period in the Pittsburgh Sleep Quality Index (PSQI) Global Score
Hide Description

The Pittsburgh Sleep Quality Index (PSQI) is a questionnaire with 18 questions to assess sleep quality. The 18 questions are distributed to 7 elements with each element ranging from 0-3. The global score is the sum score of all 7 elements and ranges from 0-21 with higher values indicating worse sleep quality.

A negative value in Change from Baseline to Week 8 indicates an improvement in sleep quality from Baseline.

Time Frame From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)
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 64.
Arm/Group Title Rotigotine
Hide Arm/Group Description:

- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.

Duration of the Titration Period: Between 1 week and 5 weeks.

- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.

Duration of the Maintenance Period: Between 3 weeks and 7 weeks.

Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours.

Overall Number of Participants Analyzed 89
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.7  (3.0)
Time Frame Adverse Events (AEs) were collected over the whole study duration from the Screening Period (Day -28 to Day -7) to the Safety Follow-up Visit (up to Day 78).
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

- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.

Duration of the Titration Period: Between 1 week and 5 weeks.

- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.

Duration of the Maintenance Period: Between 3 weeks and 7 weeks.

Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours.

All-Cause Mortality
Rotigotine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Rotigotine
Affected / at Risk (%) # Events
Total   5/90 (5.56%)    
Injury, poisoning and procedural complications   
Subdural haemorrhage * 1  1/90 (1.11%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Nasopharyngeal cancer * 1  1/90 (1.11%)  1
Psychiatric disorders   
Confusional state * 1  1/90 (1.11%)  1
Delirium * 1  1/90 (1.11%)  1
Hallucination * 1  1/90 (1.11%)  1
Renal and urinary disorders   
Urinary retention * 1  1/90 (1.11%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rotigotine
Affected / at Risk (%) # Events
Total   35/90 (38.89%)    
Gastrointestinal disorders   
Nausea * 1  7/90 (7.78%)  9
General disorders   
Application site pruritus * 1  12/90 (13.33%)  12
Infections and infestations   
Nasopharyngitis * 1  5/90 (5.56%)  5
Nervous system disorders   
Dizziness * 1  9/90 (10.00%)  11
Dyskinesia * 1  7/90 (7.78%)  7
Vascular disorders   
Orthostatic hypotension * 1  9/90 (10.00%)  11
*
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 (UCB)
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB BIOSCIENCES GmbH )
ClinicalTrials.gov Identifier: NCT01723904     History of Changes
Other Study ID Numbers: PD0015
First Submitted: November 6, 2012
First Posted: November 8, 2012
Results First Submitted: March 11, 2014
Results First Posted: June 3, 2014
Last Update Posted: June 3, 2014