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The study was stopped due to low enrollment.
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The primary purpose is to demonstrate superiority of Rotigotine over Placebo on motor symptoms when used in subjects with symptoms of Gastrointestinal Dysfunction. Hypothesis: Rotigotine will decrease OFF time compared to Placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rotigotine | Experimental | Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached. |
|
| Placebo | Placebo Comparator | Placebo patch. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotigotine | Drug | Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours Dosage and Frequency: One patch every 24 hours Duration: 10 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Rotigotine Versus Placebo in the Absolute Time Spent "Off" From Baseline to the End of the 7-week Maintenance Period | Mean number of hours marked "off" during a 24-hour period. | Baseline to 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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). | Baseline to 10 weeks |
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Inclusion Criteria:
Subject is informed and given ample time and opportunity to think about his/her participation in this study and has given his/her written informed consent on an Institutional Review Board approved consent form
Subject is willing and able to comply with all study requirements (protocol, visit schedule, procedures, and medication application)
Subject is male or female and ≥ 30 years of age
Subject has Idiopathic Parkinson's Disease of more than 3 years duration, as defined by the cardinal sign, bradykinesia, plus the presence of at least 1 of the following: resting tremor, rigidity, impairment of postural reflexes; and is without any other known or suspected cause of Parkinsonism
Subject has a Hoehn & Yahr stage score II through IV
Subject must be on a stable dose of L-dopa, either short-acting or sustained release (in combination with Benserazide or Carbidopa), of at least 200 mg/day administered in at least 2 intakes, for at least 21 days prior to starting Parkinson's diaries
Subject must be able to differentiate between the "on" and "off" state (and thereby be able to recognize the Time To "On" (TTON)), and be willing and able to accurately complete a Parkinson's Disease subject diary on designated days (with assistance from caregivers, if required)
Subject must complete 6 Parkinson's diaries over a period of 6 days, with 4 of the 6 Parkinson's diaries being "valid" as determined by the investigator. The "valid" Parkinson's diaries confirm that the subject has an average of at least 2.5 h/day spent in the "off" state
Subject receiving a Monoamine Oxidase (MAO)-B Inhibitor (eg, Selegiline or Rasagiline), an n-Methyl-d-Aspartate Antagonist (eg, Amantadine), or allowed anti-Parkinson medications and has been on a stable dose for at least 21 days prior to starting Parkinson's diaries and is anticipated to be maintained on that dose for the duration of the study
Subject has clinical symptoms of Gastrointestinal Dysfunction (GID) confirmed by at least 1 of the following
•Parkinson's disease-related GI symptoms as per the Gastrointestinal Degenerative Scale (GIND) Scale: defecatory dysfunction, constipation, excessive gas, abdominal pain, bloating, nausea, vomiting, anorexia, early satiety, or weight loss (except sialorrhea and dysphagia)
Female subjects of childbearing potential must agree to use 1 of the following contraceptive methods: oral contraceptive, intrauterine device, or double-barrier method, throughout the study and for 2 weeks after the removal of study medication
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | 877-822-9493 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 011 | Birmingham | Alabama | United States | |||
| 001 |
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| Label | URL |
|---|---|
| FDA safety Alerts and Recalls | View source |
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A total of approximately 150 subjects were planned to be randomized in a 1:1 ratio to either Rotigotine or Placebo.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo patch Placebo: Frequency: One patch applied every 24 hours Duration: 10 weeks |
| FG001 | Rotigotine | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Placebo | Drug | Frequency: One patch applied every 24 hours Duration: 10 weeks |
|
| Change in Predictability of "Off" Time (Using MDS UPDRS Part IV Item 4.5) From Baseline to End of the 7-week Maintenance Period | 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). | Baseline to 10 weeks |
| Change in Score on Gastrointestinal Neurodegenerative Scale (GIND) From Baseline to the End of the of the 7-week Maintenance Period | 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). | Baseline to 10 weeks |
| Change in Score on Fatigue Severity Scale (FSS) From Baseline to the End of 7-week Maintenance Period | 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). | Baseline to 10 weeks |
| Change in Score on Parkinson's Disease Questionnaire (PDQ8) From Baseline to the End of 7-week Maintenance Period | 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). | Baseline to 10 weeks |
| Gilbert |
| Arizona |
| United States |
| 022 | Fountain Valley | California | United States |
| 017 | Irvine | California | United States |
| 028 | Pasadena | California | United States |
| 015 | Sunnyvale | California | United States |
| 008 | Gainesville | Florida | United States |
| 009 | Miami | Florida | United States |
| 010 | Ormond Beach | Florida | United States |
| 006 | Sunrise | Florida | United States |
| 032 | Annapolis | Maryland | United States |
| 027 | Lincoln | Nebraska | United States |
| 016 | Commack | New York | United States |
| 026 | Mineola | New York | United States |
| 034 | Charlotte | North Carolina | United States |
| 002 | Raleigh | North Carolina | United States |
| 007 | Salisbury | North Carolina | United States |
| 021 | Toledo | Ohio | United States |
| 023 | Tulsa | Oklahoma | United States |
| 031 | Cordova | Tennessee | United States |
| 018 | Memphis | Tennessee | United States |
| 014 | Houston | Texas | United States |
| 030 | Richmond | Virginia | United States |
| 003 | Virginia Beach | Virginia | United States |
| 012 | Kirkland | Washington | United States |
| 013 | Milwaukee | Wisconsin | United States |
| COMPLETED |
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| NOT COMPLETED |
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|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo patch Placebo: Frequency: One patch applied every 24 hours Duration: 10 weeks |
| BG001 | Rotigotine | 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 |
| BG002 | Total | Total of all reporting groups |
| 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 |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Weight | Mean | Standard Deviation | kilogram |
| |||||||||||||||
| Height | Mean | Standard Deviation | centimeter |
| |||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kilogram/m^2 |
|
| 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 | Change in Rotigotine Versus Placebo in the Absolute Time Spent "Off" From Baseline to the End of the 7-week Maintenance Period | Mean number of hours marked "off" during a 24-hour period. | 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. | Posted | Baseline to 10 weeks |
|
| ||||||||||||||||||||||
| Secondary | 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 | 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). | 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. | Posted | Baseline to 10 weeks |
|
| ||||||||||||||||||||||
| Secondary | Change in Predictability of "Off" Time (Using MDS UPDRS Part IV Item 4.5) From Baseline to End of the 7-week Maintenance Period | 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). | 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. | Posted | Baseline to 10 weeks |
|
| ||||||||||||||||||||||
| Secondary | Change in Score on Gastrointestinal Neurodegenerative Scale (GIND) From Baseline to the End of the of the 7-week Maintenance Period | 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). | 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. | Posted | Baseline to 10 weeks |
|
| ||||||||||||||||||||||
| Secondary | Change in Score on Fatigue Severity Scale (FSS) From Baseline to the End of 7-week Maintenance Period | 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). | 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. | Posted | Baseline to 10 weeks |
|
| ||||||||||||||||||||||
| Secondary | Change in Score on Parkinson's Disease Questionnaire (PDQ8) From Baseline to the End of 7-week Maintenance Period | 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). | 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. | Posted | Baseline to 10 weeks |
|
|
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).
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo patch Placebo: Frequency: One patch applied every 24 hours Duration: 10 weeks | 0 | 12 | 4 | 12 | ||
| EG001 | Rotigotine | 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 | 1 | 13 | 5 | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ankle fracture | Injury, poisoning and procedural complications | 9.1 | Non-systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | 9.1 | Non-systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | 9.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspepsia | Gastrointestinal disorders | 9.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 9.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 9.1 | Non-systematic Assessment |
| |
| Wound infection staphylococcal | Infections and infestations | 9.1 | Non-systematic Assessment |
| |
| Brain contusion | Injury, poisoning and procedural complications | 9.1 | Non-systematic Assessment |
| |
| Traumatic brain injury | Injury, poisoning and procedural complications | 9.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | 9.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 9.1 | Non-systematic Assessment |
| |
| Dyskinesia | Nervous system disorders | 9.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | 9.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | 9.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | 9.1 | Non-systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | 9.1 | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | 9.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 9.1 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | 9.1 | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB Clinical Trial Call Center | UCB | +1 877 822 9493 |
| ID | Term |
|---|---|
| C047508 | rotigotine |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|