Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT number: 2006-006907-35 | Other Identifier | EudraCT |
Not provided
Not provided
Not provided
Due to clinical trial supplies shortage
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this open-label extension is to assess the long-term effect of the 24-hour transdermal delivery of rotigotine on motor function, sleep quality, and nocturnal and non-motor symptoms of Parkinson's disease. The long-term safety and tolerability of the rotigotine transdermal patch will also be evaluated.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rotigotine | Experimental | Rotigotine Transdermal Patch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotigotine | Drug | Rotigotine transdermal patches: 10cm2 (2mg/24h); 20cm2 (4mg/24h); 30cm2 (6mg/24h); 40cm2 (8mg/24h) Optimal dosing: The maximum rotigotine dose allowed is 16mg/24h |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in UPDRS III Score at Week 13 (End of Maintenance) | 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 elements in the UPDRS III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. Baseline is defined as first titration visit (T1) of SP915. | Baseline (baseline SP915) and week 13 (End of maintenance) |
| Change From Baseline in Parkinson Disease Sleep Scale (PDSS) at Week 13 (End of Maintenance) | The Parkinson Disease Sleep Scale (PDSS) is a questionnaire with 15 questions to assess sleep and nocturnal disability in Parkinson´s disease. The item- scores range between 0= never and 4= very often. Baseline is defined as Visit 2 of previous double- blind trial SP889. | Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS) at Week 13 (End of Maintenance) | Subjects were asked to assess nocturnal akinesia, dystonia and cramps, using an ordinal severity scale. While a score of 0= normal and 4= maximal severity, subjects could also rate their symptoms with values of 0.5, 1.5, 2.5, 3.5. The nocturnal akinesia score was used to evaluate motor performance while the dystonia and cramps scores were used to evaluate sleep. Baseline is defined as Visit 2 of previous double- blind trial SP889. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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 |
|---|---|---|---|---|---|---|
| St. Petersburg | Florida | 33701 | United States | |||
Not provided
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
Not provided
Participant Flow information belong to the Enrolled Set (ES). Baseline Characteristics are described for the Full Analysis Set (FAS).
A total of 84 subjects belong to the Enrolled Set (ES) and all of them received at least 1 dose of trial medication, so they all belong to the Safety Set (SS). 83 subjects belong to the Full Analysis Set (FAS).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Rotigotine | Rotigotine Transdermal Patch |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance) |
| Change From Baseline in Number of Nocturias at Week 13 (End of Maintenance) | The change in number of nocturias was used to evaluate improvements in sleep disorders. Baseline is defined as Visit 2 of previous double- blind trial SP889. | Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance) |
| Salisbury |
| North Carolina |
| 28144 |
| United States |
| Concord | Australia |
| Oulu | 90220 | Finland |
| Berlin | 10713 | Germany |
| Dresden | 01307 | Germany |
| Kassel | 34128 | Germany |
| Marburg | 35039 | Germany |
| Naumburg | 06618 | Germany |
| Ulm | 89081 | Germany |
| Budapest | 1145 | Hungary |
| Nyíregyháza | 4400 | Hungary |
| Chieti | Italy |
| Milan | 20127 | Italy |
| Christchurch | New Zealand |
| Olyszytn | Poland |
| Cape Town | South Africa |
| Barcelona | Spain |
| Madrid | Spain |
| Lancashire | United Kingdom |
| Liverpool | L9 7JL | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Rotigotine | Rotigotine Transdermal Patch |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| L- Dopa | Number | participants |
| |||||||||||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/ m^2 |
| ||||||||||||||||||||||
| Height | Mean | Standard Deviation | cm |
| ||||||||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
|
| 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 From Baseline in UPDRS III Score at Week 13 (End of Maintenance) | 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 elements in the UPDRS III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. Baseline is defined as first titration visit (T1) of SP915. | Full Analysis Set (FAS). | Posted | Mean | Standard Deviation | units on a scale | Baseline (baseline SP915) and week 13 (End of maintenance) |
|
|
| |||||||||||||||||||||||||
| Primary | Change From Baseline in Parkinson Disease Sleep Scale (PDSS) at Week 13 (End of Maintenance) | The Parkinson Disease Sleep Scale (PDSS) is a questionnaire with 15 questions to assess sleep and nocturnal disability in Parkinson´s disease. The item- scores range between 0= never and 4= very often. Baseline is defined as Visit 2 of previous double- blind trial SP889. | Full Analysis Set (FAS). | Posted | Mean | Standard Deviation | units on a scale | Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance) |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS) at Week 13 (End of Maintenance) | Subjects were asked to assess nocturnal akinesia, dystonia and cramps, using an ordinal severity scale. While a score of 0= normal and 4= maximal severity, subjects could also rate their symptoms with values of 0.5, 1.5, 2.5, 3.5. The nocturnal akinesia score was used to evaluate motor performance while the dystonia and cramps scores were used to evaluate sleep. Baseline is defined as Visit 2 of previous double- blind trial SP889. | Full Analysis Set (FAS). | Posted | Mean | Standard Deviation | units on a scale | Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance) |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Number of Nocturias at Week 13 (End of Maintenance) | The change in number of nocturias was used to evaluate improvements in sleep disorders. Baseline is defined as Visit 2 of previous double- blind trial SP889. | Full Analysis Set (FAS). | Posted | Mean | Standard Deviation | Nocturias | Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance) |
|
|
Adverse Events (AEs) were collected over the whole trial period from Visit 1 to the Safety Follow- Up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least 1 dose of trial medication.
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 | Rotigotine Transdermal Patch | 16 | 84 | 55 | 84 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Atrioventricular block third degree | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Reflux oesophagitis | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Application site vesicles | General disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
| |
| Post procedural haematuria | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
| |
| Eosinophil count increased | Investigations | MedDRA (9.1) | Systematic Assessment |
| |
| Trigger finger | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Systematic Assessment |
| |
| Syncope vasovagal | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Peroneal nerve palsy | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (9.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Application site pruritus | General disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Application site erythema | General disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Application site irritation | General disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Dyskinesia | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Parkinson´s disease | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (9.1) | Systematic Assessment |
|
Because the manufacturing process for rotigotine patches was changed, enrollment into SP915 was stopped in April 2008 to ensure sufficient trial medication for all subjects enrolled at that time to complete the trial according to the protocol.
UCB has > 60 days 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 results shall be published regardless of outcome.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB Clinical Trial Call Center | UCB | +18778229493 |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C047508 | rotigotine |
Not provided
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|