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Trial record 1 of 1 for:    NCT01536015
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Effect of Rotigotine on Motor Symptoms in Patients With Advanced Parkinson's Disease (PD) With Motor Fluctuations and Symptoms of Gastrointestinal Dysfunction (ROADMAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01536015
Recruitment Status : Terminated (The study was stopped due to low enrollment.)
First Posted : February 20, 2012
Results First Posted : August 1, 2014
Last Update Posted : August 1, 2014
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Advanced Parkinson's Disease
Interventions Drug: Rotigotine
Drug: Placebo
Enrollment 25
Recruitment Details The total duration of the study was to be a maximum of 19 weeks for each subject, including the Screening Period (within 50 days prior to Day 1), the Titration Period (up to 3 weeks), the Maintenance Period (up to 7 weeks), and a Safety Follow-Up Visit. The Participant Flow refers to the Randomized Set which includes all randomized subjects.
Pre-assignment Details A total of approximately 150 subjects were planned to be randomized in a 1:1 ratio to either Rotigotine or Placebo.
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description

Placebo patch

Placebo: Frequency: One patch applied every 24 hours

Duration: 10 weeks

Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.

Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours

Dosage and Frequency: One patch every 24 hours

Duration: 10 weeks

Period Title: Overall Study
Started 12 13
Completed 4 3
Not Completed 8 10
Reason Not Completed
Adverse Event             1             4
Lost to Follow-up             0             1
Inclusion Criterion not met             2             0
Study closure             5             5
Arm/Group Title Placebo Rotigotine Total
Hide Arm/Group Description

Placebo patch

Placebo: Frequency: One patch applied every 24 hours

Duration: 10 weeks

Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.

Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours

Dosage and Frequency: One patch every 24 hours

Duration: 10 weeks

Total of all reporting groups
Overall Number of Baseline Participants 12 13 25
Hide Baseline Analysis Population Description
The Analysis Population Description refers to the Safety Set (SS) which consists of all randomized subjects who received at least one dose of study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 13 participants 25 participants
66.1  (8.2) 66.7  (9.6) 66.4  (8.8)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 13 participants 25 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
  41.7%
6
  46.2%
11
  44.0%
>=65 years
7
  58.3%
7
  53.8%
14
  56.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 13 participants 25 participants
Female
4
  33.3%
3
  23.1%
7
  28.0%
Male
8
  66.7%
10
  76.9%
18
  72.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 13 participants 25 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
4
  30.8%
4
  16.0%
White
11
  91.7%
8
  61.5%
19
  76.0%
More than one race
1
   8.3%
1
   7.7%
2
   8.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 13 participants 25 participants
12 13 25
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram
Number Analyzed 12 participants 13 participants 25 participants
84.64  (14.93) 76.67  (19.53) 80.50  (17.58)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeter
Number Analyzed 12 participants 13 participants 25 participants
171.79  (13.65) 173.86  (10.61) 172.87  (11.95)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kilogram/m^2
Number Analyzed 12 participants 13 participants 25 participants
28.714  (4.167) 25.113  (4.809) 26.842  (4.785)
1.Primary Outcome
Title Change in Rotigotine Versus Placebo in the Absolute Time Spent "Off" From Baseline to the End of the 7-week Maintenance Period
Hide Description Mean number of hours marked "off" during a 24-hour period.
Time Frame Baseline to 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early because of low enrollment. Due to the early termination no analysis tables of efficacy data were done and no descriptive summaries of efficacy data were produced.
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo patch

Placebo: Frequency: One patch applied every 24 hours

Duration: 10 weeks

Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.

Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours

Dosage and Frequency: One patch every 24 hours

Duration: 10 weeks

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS UPDRS) Part III (Motor Examination) in the "on" State From Baseline to the End of the 7-week Maintenance Period
Hide Description The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS UPDRS) Part III is an 18-item scale with each single item of the scale ranging from 0 (normal) to 4 (severe).
Time Frame Baseline to 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early because of low enrollment. Due to the early termination no analysis tables of efficacy data were done and no descriptive summaries of efficacy data were produced.
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo patch

Placebo: Frequency: One patch applied every 24 hours

Duration: 10 weeks

Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.

Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours

Dosage and Frequency: One patch every 24 hours

Duration: 10 weeks

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Change in Predictability of "Off" Time (Using MDS UPDRS Part IV Item 4.5) From Baseline to End of the 7-week Maintenance Period
Hide Description The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS UPDRS) Part IV is a 6-item scale with each single item of the scale ranging from 0 (normal) to 4 (severe).
Time Frame Baseline to 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early because of low enrollment. Due to the early termination no analysis tables of efficacy data were done and no descriptive summaries of efficacy data were produced.
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo patch

Placebo: Frequency: One patch applied every 24 hours

Duration: 10 weeks

Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.

Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours

Dosage and Frequency: One patch every 24 hours

Duration: 10 weeks

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Change in Score on Gastrointestinal Neurodegenerative Scale (GIND) From Baseline to the End of the of the 7-week Maintenance Period
Hide Description Gastrointestinal Neurodegenerative Scale (GIND) is an 18-item scale measuring gastrointestinal dysfunction with each single item of the scale ranging from 0 (never or not at all) to 5 (very severe).
Time Frame Baseline to 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early because of low enrollment. Due to the early termination no analysis tables of efficacy data were done and no descriptive summaries of efficacy data were produced.
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo patch

Placebo: Frequency: One patch applied every 24 hours

Duration: 10 weeks

Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.

Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours

Dosage and Frequency: One patch every 24 hours

Duration: 10 weeks

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Change in Score on Fatigue Severity Scale (FSS) From Baseline to the End of 7-week Maintenance Period
Hide Description The Fatigue Severity Scale is a 9-item scale measuring the impact of fatigue on everyday functioning (e.g. "fatigue interferes with my work, each single item of the scale ranging from 1 (disagree) to 7 (agree).
Time Frame Baseline to 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early because of low enrollment. Due to the early termination no analysis tables of efficacy data were done and no descriptive summaries of efficacy data were produced.
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo patch

Placebo: Frequency: One patch applied every 24 hours

Duration: 10 weeks

Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.

Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours

Dosage and Frequency: One patch every 24 hours

Duration: 10 weeks

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Change in Score on Parkinson's Disease Questionnaire (PDQ8) From Baseline to the End of 7-week Maintenance Period
Hide Description The Parkinson's Disease Questionnaire (PDQ-8) is a self-administered 8-item questionnaire that assesses issues associated with Parkinson's disease. Each single item of the 8-item questionnaire ranges from 0 (never) to 4 (always).
Time Frame Baseline to 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early because of low enrollment. Due to the early termination no analysis tables of efficacy data were done and no descriptive summaries of efficacy data were produced.
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo patch

Placebo: Frequency: One patch applied every 24 hours

Duration: 10 weeks

Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.

Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours

Dosage and Frequency: One patch every 24 hours

Duration: 10 weeks

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame From Screening (Day -50 to Day -1) up to the Safety Follow-up Visit (14±2 days after the End of Maintenance/Start of De-Escalation Visit or Premature Withdrawal/Start of De-Escalation Visit).
Adverse Event Reporting Description Only Treatment Emergent Adverse Events were reported. The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects who received at least 1 dose of study medication.
 
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description

Placebo patch

Placebo: Frequency: One patch applied every 24 hours

Duration: 10 weeks

Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.

Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours

Dosage and Frequency: One patch every 24 hours

Duration: 10 weeks

All-Cause Mortality
Placebo Rotigotine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Placebo Rotigotine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      1/13 (7.69%)    
Injury, poisoning and procedural complications     
Ankle fracture * 1  0/12 (0.00%)  0 1/13 (7.69%)  1
Skin laceration * 1  0/12 (0.00%)  0 1/13 (7.69%)  1
Skin and subcutaneous tissue disorders     
Decubitus ulcer * 1  0/12 (0.00%)  0 1/13 (7.69%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, 9.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Rotigotine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/12 (33.33%)      5/13 (38.46%)    
Gastrointestinal disorders     
Dyspepsia * 1  0/12 (0.00%)  0 1/13 (7.69%)  1
Abdominal pain * 1  1/12 (8.33%)  1 0/13 (0.00%)  0
Vomiting * 1  1/12 (8.33%)  1 0/13 (0.00%)  0
Infections and infestations     
Wound infection staphylococcal * 1  0/12 (0.00%)  0 1/13 (7.69%)  1
Injury, poisoning and procedural complications     
Brain contusion * 1  0/12 (0.00%)  0 1/13 (7.69%)  1
Traumatic brain injury * 1  0/12 (0.00%)  0 1/13 (7.69%)  1
Fall * 1  0/12 (0.00%)  0 1/13 (7.69%)  2
Musculoskeletal and connective tissue disorders     
Pain in extremity * 1  1/12 (8.33%)  1 1/13 (7.69%)  3
Nervous system disorders     
Dyskinesia * 1  1/12 (8.33%)  1 2/13 (15.38%)  5
Dizziness * 1  0/12 (0.00%)  0 1/13 (7.69%)  1
Headache * 1  2/12 (16.67%)  3 0/13 (0.00%)  0
Paraesthesia * 1  1/12 (8.33%)  1 0/13 (0.00%)  0
Psychiatric disorders     
Psychotic disorder * 1  0/12 (0.00%)  0 1/13 (7.69%)  1
Suicidal ideation * 1  0/12 (0.00%)  0 1/13 (7.69%)  1
Respiratory, thoracic and mediastinal disorders     
Cough * 1  0/12 (0.00%)  0 1/13 (7.69%)  1
Nasal congestion * 1  0/12 (0.00%)  0 1/13 (7.69%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, 9.1
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
ClinicalTrials.gov Identifier: NCT01536015    
Other Study ID Numbers: SP1055
First Submitted: February 15, 2012
First Posted: February 20, 2012
Results First Submitted: July 7, 2014
Results First Posted: August 1, 2014
Last Update Posted: August 1, 2014