Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Otsuka Pharmaceutical Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the safety and feasibility of switching subjects with advanced Parkinson's Disease (PD) from Pramipexole or Ropinirole to Rotigotine and to assess the effects of Rotigotine on motor and non-motor symptoms of Parkinson's Disease in subjects switched from previous treatment with either Pramipexole or Ropinirole.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rotigotine | Experimental | First application of Rotigotine patch for 24 hours on Day 1, followed by application of a new patch each day of the Treatment Period.
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotigotine | Drug | Rotigotine up to 16 mg / 24 hours, 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period or Early Withdrawal Visit | The CGI Item 4 was used to assess side effects. It ranges from 0 to 4 as follows:
| Day 28 (Visit 5) of the 28 days Treatment Period or Early Withdrawal Visit |
| Measure | Description | Time Frame |
|---|---|---|
| Patients Global Impressions of Change (PGIC) at the End of the Treatment Period or Early Withdrawal Visit | The PGIC is a 7-point categorical rating scale in which the subject rates the changes in functioning over time as follows:
| Day 28 (Visit 5) of the 28 days Treatment Period or Early Withdrawal Visit |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 505 | Anniston | Alabama | United States | |||
| 506 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25846031 | Derived | Chung SJ, Kim JM, Kim JW, Jeon BS, Singh P, Thierfelder S, Ikeda J, Bauer L; Asia Pacific Rotigotine Switching Study Group. Switch from oral pramipexole or ropinirole to rotigotine transdermal system in advanced Parkinson's disease: an open-label study. Expert Opin Pharmacother. 2015 May;16(7):961-70. doi: 10.1517/14656566.2015.1030336. Epub 2015 Apr 6. |
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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.
Rotigotine: Rotigotine up to 16 mg / 24 hours, 4 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Atlantis |
| Florida |
| United States |
| 508 | Miami Springs | Florida | United States |
| 502 | Atlanta | Georgia | United States |
| 501 | Dayton | Ohio | United States |
| 509 | Oklahoma City | Oklahoma | United States |
| 202 | Sarawak | Malaysia |
| 401 | Singapore | Singapore |
| 403 | Singapore | Singapore |
| 101 | Busan | South Korea |
| 102 | Busan | South Korea |
| 108 | Daegu | South Korea |
| 109 | Daegu | South Korea |
| 105 | Gyeonggi-do | South Korea |
| 103 | Seoul | South Korea |
| 104 | Seoul | South Korea |
| 106 | Seoul | South Korea |
| 107 | Seoul | South Korea |
| 301 | Linkou District | Taiwan |
| 304 | Taichung | Taiwan |
| 305 | Taipei | Taiwan |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline characteristics refer to the Safety Set. The Safety Set consists of all subjects who had at least one patch application.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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.
Rotigotine: Rotigotine up to 16 mg / 24 hours, 4 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period or Early Withdrawal Visit | The CGI Item 4 was used to assess side effects. It ranges from 0 to 4 as follows:
| 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. | Posted | Number | participants | Day 28 (Visit 5) of the 28 days Treatment Period or Early Withdrawal Visit |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Patients Global Impressions of Change (PGIC) at the End of the Treatment Period or Early Withdrawal Visit | The PGIC is a 7-point categorical rating scale in which the subject rates the changes in functioning over time as follows:
| 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. | Posted | Number | participants | Day 28 (Visit 5) of the 28 days Treatment Period or Early Withdrawal Visit |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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.
Rotigotine: Rotigotine up to 16 mg / 24 hours, 4 weeks. | 1 | 87 | 30 | 87 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site pruritus | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Application site erythema | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Dyskinesia | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB Clinical Trial Call Center | UCB | +1 877 822 9493 |
| ID | Term |
|---|---|
| C047508 | rotigotine |
Not provided
Not provided
Not provided
| >=65 years |
|
| Malaysia |
|
| Singapore |
|
| Korea, Republic of |
|
| Title | Measurements |
|---|---|
|
| CGI Item 4 score of 4 |
|
| CGI Item 4 score of 3 or 4 |
|
|
|