Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT No.: 2006-006752-35 | Other Identifier | EudraCT |
Not provided
Not provided
Not provided
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 trial is to assess the effects of transdermal rotigotine on the control of early morning motor function and sleep disorders compared to placebo in subjects with idiopathic Parkinsons´s disease. In addition, effects of rotigotine on specific nocturnal and non-motor symptoms of Parkinson´s disease will be evaluated.
The objective of this trial is to assess the effects of rotigotine on the control of early morning motor function and sleep disorders compared to placebo in subjects with idiopathic Parkinsons´s disease. In addition, effects of rotigotine on specific nocturnal and non-motor symptoms of Parkinson´s disease will be evaluated.
After a Screening Period of up to 28 days subjects will be hospitalized for two nights. After the second overnight stay, subjects will be randomly assigned either to rotigotine patch or placebo patch. Afterwards patients will be titrated to their optimal dose. After subjects have reached their optimal dose (or the highest dose) they will be maintained on this dose for a certain period. At the end of maintenance the subjects will be hospitalized for two nights. Afterwards the doses will be continuously decreased.
Efficacy will be assessed by application of sleep quality scores, motor examination scores, and scores to evaluate non-motor symptoms of Parkinsons. Safety assessments include adverse events, 12-lead electrocardiograms, blood pressure and heart rate assessments, and laboratory checks.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rotigotine | Experimental | Rotigotine transdermal patch |
|
| Placebo | Placebo Comparator | Placebo 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 in Early Morning UPDRS Part III Score | The Unified Parkinson´s Disease Rating Scale Part III score is an accepted and validated sumscore of 14 items for the assessment of motor function in Parkinson´s disease. Each of the 14 items in the UPDRS part III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. | From baseline to end of maintenance (after 4 weeks maintenance) |
| Change in Parkinson's Disease Sleep Scale (PDSS) | The Parkinson´s Disease Sleep Scale (PDSS) is a questionnaire with 15 questions to assess sleep and nocturnal disability in Parkinson´s disease. The item- scores can range between 0= never and 4= very often. The PDSS score is a sumscore of all 15 questions. | From baseline to end of maintenance (after 4 weeks maintenance) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS) | 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. |
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 |
|---|---|---|---|---|---|---|
| Reseda | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21790503 | Result | Ghys L, Surmann E, Whitesides J, Boroojerdi B. Effect of rotigotine on sleep and quality of life in Parkinson's disease patients: post hoc analysis of RECOVER patients who were symptomatic at baseline. Expert Opin Pharmacother. 2011 Sep;12(13):1985-98. doi: 10.1517/14656566.2011.604031. Epub 2011 Jul 27. | |
| 24602411 | Derived |
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
Not provided
Participant Flow shows all 287 subjects who has been enrolled and randomized. Baseline Characteristics are described for the Full Analysis Set (FAS).
A total of 333 subjects were enrolled in this trial and comprised the Enrolled Set (ES). 287 subjects were randomized and all of them received at least 1 dose of trial medication, so they all belong to the Safety Set (SS). 267 subjects belong to the Full Analysis Set (FAS).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Rotigotine | Rotigotine transdermal patch |
| FG001 | Placebo | Placebo transdermal patch |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Other | Placebo transdermal patches |
|
| From baseline to end of maintenance (after 4 weeks maintenance) |
| Change in Number of Nocturias | Nocturia is the need to get up during the night and interrupt sleep in order to urinate. It is a typical nocturnal symptom of Parkinson´s disease. The change from baseline in number of nocturias was used to evaluate improvements in sleep disorders. | From baseline to end of maintenance (after 4 weeks maintenance) |
| Ventura |
| California |
| United States |
| St. Petersburg | Florida | 33701 | United States |
| Salisbury | North Carolina | 28144 | United States |
| Winston_Salem | North Carolina | United States |
| Warwick | Rhode Island | United States |
| Houston | Texas | United States |
| Concord | New South Wales | Australia |
| Adelaide | South Australia | Australia |
| Fitzroy | Australia |
| Innsbruck | 6020 | Austria |
| Hyvinkää | Finland |
| Oulu | 90220 | Finland |
| Berlin | 10713 | Germany |
| Berlin | 12163 | Germany |
| Dresden | 01307 | Germany |
| Kassel | 34128 | Germany |
| Leipzig | Germany |
| Marburg | 35039 | Germany |
| Naumburg | Germany |
| Ulm | 89081 | Germany |
| Budapest | Hungary |
| Debrecen | Hungary |
| Nyíregyháza | Hungary |
| Zalaegerszeg | Hungary |
| Chieti | 66013 | Italy |
| Milan | Italy |
| Torino | Italy |
| Christchurch | New Zealand |
| Wellington | New Zealand |
| Gdansk | Poland |
| Krakow | Poland |
| Lublin | Poland |
| Olsztyn | Poland |
| Szczecin | Poland |
| Warsaw | Poland |
| Cape Town | South Africa |
| Capetown | South Africa |
| Johannesburg | South Africa |
| Pretoria/Gauteng | South Africa |
| Tygerberg | South Africa |
| Barcelona | 08036 | Spain |
| Madrid | Spain |
| Bristol | United Kingdom |
| Lancashire | United Kingdom |
| Liverpool | United Kingdom |
| London | United Kingdom |
| Kassubek J, Chaudhuri KR, Zesiewicz T, Surmann E, Boroojerdi B, Moran K, Ghys L, Trenkwalder C. Rotigotine transdermal system and evaluation of pain in patients with Parkinson's disease: a post hoc analysis of the RECOVER study. BMC Neurol. 2014 Mar 6;14:42. doi: 10.1186/1471-2377-14-42. |
| 24457253 | Derived | Swick TJ, Friedman JH, Chaudhuri KR, Surmann E, Boroojerdi B, Moran K, Ghys L, Trenkwalder C. Associations between severity of motor function and nonmotor symptoms in Parkinson's disease: a post hoc analysis of the RECOVER Study. Eur Neurol. 2014;71(3-4):140-7. doi: 10.1159/000355019. Epub 2014 Jan 21. |
| 21322021 | Derived | Trenkwalder C, Kies B, Rudzinska M, Fine J, Nikl J, Honczarenko K, Dioszeghy P, Hill D, Anderson T, Myllyla V, Kassubek J, Steiger M, Zucconi M, Tolosa E, Poewe W, Surmann E, Whitesides J, Boroojerdi B, Chaudhuri KR; Recover Study Group. Rotigotine effects on early morning motor function and sleep in Parkinson's disease: a double-blind, randomized, placebo-controlled study (RECOVER). Mov Disord. 2011 Jan;26(1):90-9. doi: 10.1002/mds.23441. Epub 2010 Nov 18. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Rotigotine | Rotigotine transdermal patch |
| BG001 | Placebo | Placebo transdermal patch |
| 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, 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 |
| ||||||||||||||||||
| 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 in Early Morning UPDRS Part III Score | The Unified Parkinson´s Disease Rating Scale Part III score is an accepted and validated sumscore of 14 items for the assessment of motor function in Parkinson´s disease. Each of the 14 items in the UPDRS part III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. | Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). | Posted | Mean | Standard Deviation | units on a scale | From baseline to end of maintenance (after 4 weeks maintenance) |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change in Parkinson's Disease Sleep Scale (PDSS) | The Parkinson´s Disease Sleep Scale (PDSS) is a questionnaire with 15 questions to assess sleep and nocturnal disability in Parkinson´s disease. The item- scores can range between 0= never and 4= very often. The PDSS score is a sumscore of all 15 questions. | Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). | Posted | Mean | Standard Deviation | units on a scale | From baseline to end of maintenance (after 4 weeks maintenance) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS) | 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. | Full Analysis Set (FAS). | Posted | Mean | Standard Deviation | units on a scale | From baseline to end of maintenance (after 4 weeks maintenance) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Number of Nocturias | Nocturia is the need to get up during the night and interrupt sleep in order to urinate. It is a typical nocturnal symptom of Parkinson´s disease. The change from baseline in number of nocturias was used to evaluate improvements in sleep disorders. | Full Analysis Set (FAS). | Posted | Mean | Standard Deviation | nocturias | From baseline to end of maintenance (after 4 weeks maintenance) |
|
|
Adverse Events (AEs) were collected up to 22 weeks 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 are randomized and received at least one 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 | 10 | 191 | 70 | 191 | ||
| EG001 | Placebo | Placebo transdermal patch | 5 | 96 | 21 | 96 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Abortion | Pregnancy, puerperium and perinatal conditions | MedDRA (9.1) | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Hallucination, visual | Psychiatric disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Sleep attacks | Psychiatric disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Nephrotic syndrome | Renal and urinary disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Dyskinesia | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
|
During the course of the trial, the manufacturing process for rotigotine was changed. At that time, the expiry date for trial medication was Apr 2009, recruitment for SP889 had to be stopped effective on 17 Nov 2008.
"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 | +1877 822 9493 |
| 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
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|
|