Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01646268
Previous Study | Return to List | Next Study

Rotigotine Versus Placebo As Double Blind Study To Evaluate The Efficacy In Early Stage Idiopathic Parkinson's Disease Patients

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: NCT01646268
Recruitment Status : Completed
First Posted : July 20, 2012
Results First Posted : August 11, 2015
Last Update Posted : August 11, 2015
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition IDIOPATHIC PARKINSON'S DISEASE
Interventions Drug: Rotigotine
Drug: Placebo Patch
Enrollment 249
Recruitment Details The SP0914 study began recruitment in July 2012 and concluded in May 2014. All subjects were recruited in China.
Pre-assignment Details The Participant Flow and Demographics data is taken from the Randomized Set (RS). The RS includes all subjects that were randomized.
Arm/Group Title Rotigotine Placebo
Hide Arm/Group Description

Rotigotine, daily doses, treatment group

Rotigotine: Transdermal Patch

Content:

2 mg /24 h (10 cm^2), 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)

For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period.

Placebo, daily doses, placebo group

Placebo Patch: Transdermal Patch

Size:

10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2

Subjects randomized to placebo will receive matching placebo patches.

Period Title: Overall Study
Started 124 123
Completed 113 107
Not Completed 11 16
Reason Not Completed
Adverse Event             6             7
Lack of Efficacy             1             3
Protocol Violation             0             1
Withdrawal by Subject             2             5
Other             2             0
Arm/Group Title Rotigotine Placebo Total
Hide Arm/Group Description

Rotigotine, daily doses, treatment group

Rotigotine: Transdermal Patch

Content:

2 mg /24 h (10 cm^2), 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)

For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period.

Placebo, daily doses, placebo group

Placebo Patch: Transdermal Patch

Size:

10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2

Subjects randomized to placebo will receive matching placebo patches.

Total of all reporting groups
Overall Number of Baseline Participants 124 123 247
Hide Baseline Analysis Population Description
Baseline Demographics data is taken from the Randomized Set (RS). The RS includes all subjects that were randomized.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 124 participants 123 participants 247 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
88
  71.0%
82
  66.7%
170
  68.8%
>=65 years
36
  29.0%
41
  33.3%
77
  31.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 124 participants 123 participants 247 participants
59.1  (10.3) 59.7  (10.1) 59.4  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 124 participants 123 participants 247 participants
Female
50
  40.3%
47
  38.2%
97
  39.3%
Male
74
  59.7%
76
  61.8%
150
  60.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 124 participants 123 participants 247 participants
124 123 247
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 124 participants 123 participants 247 participants
63.2  (10.5) 64.0  (9.9) 63.6  (10.2)
1.Primary Outcome
Title Change in the Sum of the Score From the Activities of Daily Living (ADL) Scale and Motor Examination in the Unified Parkinson's Disease Rating Scale (UPDRS) (Parts II+III, a UPDRS Subtotal) From Baseline to the End of Double-blind Maintenance Period
Hide Description

The UPDRS assessments (Parts II+III) will be performed at every visit.

For the assessment of the subject's disability, Part II of the UPDRS will be used. Data will be gathered pertaining to the subject's disease state in the "on" state. Subjects will respond to questions about their general state in the week prior to their scheduled visit in conjunction with any observations made by the investigator (or designee). For the assessment of the subject's motor function, Part III of the UPDRS will be used and the assessments will be done while the subject is in the "on" state.

The UPDRS Part II (Activities of Daily Living) consists of 13 items scored between 0 and 4. The UPDRS Part III (motor subscale) consists of 27 items and sub items scored between 0 and 4. The sum score is calculated as sum of these 27 individual scores. The sum score ranges from 0 to 160, higher scores denote greater disability.

Time Frame From Baseline (Week 0) to end of Maintenance Period (up to Week 24)
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis consists of the Full Analysis Set [Last Observation Carried Forward], which includes all subjects who are randomized, receive at least 1 dose of study medication, and have a Baseline efficacy measurement and at least 1 post-Baseline efficacy measurement.
Arm/Group Title Rotigotine Placebo
Hide Arm/Group Description:

Rotigotine, daily doses, treatment group

Rotigotine: Transdermal Patch

Content:

2 mg /24 h (10 cm^2), 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)

For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period.

Placebo, daily doses, placebo group

Placebo Patch: Transdermal Patch

Size:

10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2

Subjects randomized to placebo will receive matching placebo patches.

Overall Number of Participants Analyzed 123 121
Mean (Standard Deviation)
Unit of Measure: units on a scale
-4.9  (9.9) -0.2  (9.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rotigotine, Placebo
Comments The null hypothesis (H0) is that there is no difference in the change in the sum of the score from the ADL and motor examination in the UPDRS (Parts II+II) between the active treatment and the placebo groups (i.e., the change from Baseline in the sum of the score from the ADL and motor examination in the UPDRS (Parts II+III) is the same for both groups).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means
Estimated Value -4.82
Confidence Interval (2-Sided) 95%
-7.18 to -2.45
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.20
Estimation Comments Value describes the difference value of the mean change from baseline between Rotigotine and Placebo groups. The Value for this outcome was -4.6.
2.Secondary Outcome
Title Response to Therapy, Defined as ≥20 % Decrease in the Sum of Scores From Activities of Daily Living (ADL) & Motor Examination in Unified Parkinson's Disease Rating Scale (UPDRS Parts II+III, a UPDRS Subtotal) From Baseline to End of Maintenance Period
Hide Description

The UPDRS assessments (Parts II+III) will be performed at every visit. For the assessment of the subject's disability, Part II of the UPDRS will be used. Data will be gathered pertaining to the subject's disease state in the "on" state. Subjects will respond to questions about their general state in the week prior to their scheduled visit in conjunction with any observations made by the investigator (or designee). For the assessment of the subject's motor function, Part III of the UPDRS will be used and the assessments will be done while the subject is in the "on" state.

The UPDRS Part II (Activities of Daily Living) consists of 13 items scored between 0 and 4. The UPDRS Part III (motor subscale) consists of 27 items and sub items scored between 0 and 4. The sum score is calculated as sum of these 27 individual scores. A higher score denotes greater disability.

Time Frame From Baseline (Week 0) to end of Maintenance Period (up to Week 24)
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis consists of the Full Analysis Set [Last Observation Carried Forward], which includes all subjects who are randomized, receive at least 1 dose of study medication, and have a Baseline efficacy measurement and at least 1 post-Baseline efficacy measurement.
Arm/Group Title Rotigotine Placebo
Hide Arm/Group Description:

Rotigotine, daily doses, treatment group

Rotigotine: Transdermal Patch

Content:

2 mg /24 h (10 cm^2), 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)

For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period.

Placebo, daily doses, placebo group

Placebo Patch: Transdermal Patch

Size:

10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2

Subjects randomized to placebo will receive matching placebo patches.

Overall Number of Participants Analyzed 123 121
Measure Type: Number
Unit of Measure: percentage of responders
42.3 22.3
3.Secondary Outcome
Title Change in Unified Parkinson's Disease Rating Scale [UPDRS Part II (ADL)] From Baseline to the End of the Double-blind Maintenance Period
Hide Description

The UPDRS assessments (Parts II+III) will be performed at every visit.

For the assessment of the subject's disability, Part II of the UPDRS will be used. Data will be gathered pertaining to the subject's disease state in the "on" state. Subjects will respond to questions about their general state in the week prior to their scheduled visit in conjunction with any observations made by the investigator (or designee). The UPDRS Part II (Activities of Daily Living) consists of 13 items scored between 0 and 4. The sum score ranges from 0 to 52, higher scores denote greater disability.

Time Frame From Baseline (Week 0) to end of Maintenance Period (up to Week 24)
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis consists of the Full Analysis Set [Last Observation Carried Forward], which includes all subjects who are randomized, receive at least 1 dose of study medication, and have a Baseline efficacy measurement and at least 1 post-Baseline efficacy measurement.
Arm/Group Title Rotigotine Placebo
Hide Arm/Group Description:

Rotigotine, daily doses, treatment group

Rotigotine: Transdermal Patch

Content:

2 mg /24 h (10 cm^2), 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)

For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period.

Placebo, daily doses, placebo group

Placebo Patch: Transdermal Patch

Size:

10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2

Subjects randomized to placebo will receive matching placebo patches.

Overall Number of Participants Analyzed 123 121
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.4  (3.6) 0.1  (3.4)
4.Secondary Outcome
Title Change in Unified Parkinson's Disease Rating Scale [UPDRS Part III (Motor Examination)] From Baseline to the End of the Double-blind Maintenance Period
Hide Description

The UPDRS assessments (Parts II+III) will be performed at every visit.

For the assessment of the subject's motor function, Part III of the UPDRS will be used and the assessments will be done while the subject is in the "on" state.

The UPDRS Part III (motor subscale) consists of 27 items and sub items scored between 0 and 4. The sum score ranges from 0 to 108, higher scores denote greater disability.

Time Frame From Baseline (Week 0) to end of Maintenance Period (up to Week 24)
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis consists of the Full Analysis Set [Last Observation Carried Forward], which includes all subjects who are randomized, receive at least 1 dose of study medication, and have a Baseline efficacy measurement and at least 1 post-Baseline efficacy measurement.
Arm/Group Title Rotigotine Placebo
Hide Arm/Group Description:

Rotigotine, daily doses, treatment group

Rotigotine: Transdermal Patch

Content:

2 mg /24 h (10 cm^2), 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)

For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period.

Placebo, daily doses, placebo group

Placebo Patch: Transdermal Patch

Size:

10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2

Subjects randomized to placebo will receive matching placebo patches.

Overall Number of Participants Analyzed 123 121
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.4  (7.3) -0.3  (7.4)
Time Frame Adverse Events (AEs) were collected throughout the duration of the SP0914 study (approximately 2 years). AE data consists of the Safety Set (SS). The SS includes all randomized subjects who received at least 1 dose of study medication.
Adverse Event Reporting Description

An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.

AE and SAE data represents Treatment-emergent Adverse Events (TEAE).

 
Arm/Group Title Rotigotine Placebo
Hide Arm/Group Description

Rotigotine, daily doses, treatment group

Rotigotine: Transdermal Patch

Content:

2 mg /24 h (10 cm^2), 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)

For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period.

Placebo, daily doses, placebo group

Placebo Patch: Transdermal Patch

Size:

10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2

Subjects randomized to placebo will receive matching placebo patches.

All-Cause Mortality
Rotigotine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Rotigotine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/124 (4.84%)      1/123 (0.81%)    
Cardiac disorders     
Coronary artery disease * 1  0/124 (0.00%)  0 1/123 (0.81%)  1
Atrial fibrillation * 1  1/124 (0.81%)  1 0/123 (0.00%)  0
Congenital, familial and genetic disorders     
Myocardial bridging * 1  1/124 (0.81%)  1 0/123 (0.00%)  0
Gastrointestinal disorders     
Gastric polyps * 1  1/124 (0.81%)  1 0/123 (0.00%)  0
Large intestine polyp * 1  1/124 (0.81%)  1 0/123 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Intervertebral disc protrusion * 1  1/124 (0.81%)  1 0/123 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Parathyroid tumour benign * 1  1/124 (0.81%)  1 0/123 (0.00%)  0
Nervous system disorders     
Transient ischaemic attack * 1  1/124 (0.81%)  1 0/123 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rotigotine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   35/124 (28.23%)      18/123 (14.63%)    
Gastrointestinal disorders     
Nausea * 1  11/124 (8.87%)  16 4/123 (3.25%)  4
Vomiting * 1  7/124 (5.65%)  9 2/123 (1.63%)  2
Nervous system disorders     
Somnolence * 1  10/124 (8.06%)  10 4/123 (3.25%)  4
Dizziness * 1  10/124 (8.06%)  13 7/123 (5.69%)  9
Skin and subcutaneous tissue disorders     
Erythema * 1  8/124 (6.45%)  11 2/123 (1.63%)  2
Pruritus * 1  10/124 (8.06%)  12 5/123 (4.07%)  5
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.1
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.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: UCB Clinical Trial Call Center
Phone: +1 844-599-2279
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01646268    
Other Study ID Numbers: SP0914
First Submitted: July 18, 2012
First Posted: July 20, 2012
Results First Submitted: May 20, 2015
Results First Posted: August 11, 2015
Last Update Posted: August 11, 2015