A Phase 3 interventional study of Rotigotine in Idiopathic Parkinson's Disease, sponsored by UCB Pharma. Completed at 26 sites in 8 countries. Open to participants aged 31 Years and older. Per ClinicalTrials.gov, last updated 2014-10-02.
Sponsored by UCB Pharma (part of UCB S.A.) · Phase 3, Interventional, and Treatment
The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of rotigotine in subjects with idiopathic PD.
This is the open-label extension to the open-label trials SP824 (NCT00242008), SP825 (NCT00243971), and SP826 (NCT00243945) that assessed the efficacy and safety and tolerability of rotigotine in subjects with idiopathic Parkinson's Disease.
4,583 studies on the registry are indexed under Parkinson Disease; 1,097 are open to participants now.
This study's enrollment of 186 is above the median of 40 across 3,365 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →UCB Pharma is the lead sponsor of 242 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Rotigotine
Drug: Rotigotine
Rotigotine transdermal patches: 10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours) Optimal dosing: The maximum rotigotine dose allowed is 16 mg/24 hours.
Also known as: Neupro
Number of Subjects With at Least One Adverse Event During This Open-label Extension Study
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Time frame: four years
Number of Subjects Who Withdrew From the Trial Due to an Adverse Event
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Time frame: four years
Mean Epworth Sleepiness Scale Score During the Open-label Extension.
The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. The total ESS score is the sum of 8 item-scores and can range between 0 and 24. The higher the score, the higher the person's level of daytime sleepiness.
Time frame: Visit 6 (post year 1), Visit 10 (post year 2), Visit 14 (post year 3), End of Treatment (last study visit or early withdrawal visit)
An Open-Label Extension Trial to Assess the Safety and Tolerability of Long-term Treatment of Rotigotine in Subjects with Idiopathic Parkinson's Disease in 26 locations from February 2005 to December 2008.
| Milestone | Rotigotine |
|---|---|
| Started | 186 |
| Completed | 91 |
| Not completed | 95 |
| Withdrew: Important protocol violation | 2 |
| Withdrew: Lack of efficacy | 15 |
| Withdrew: Adverse event | 48 |
| Withdrew: Subject withdrew consent | 15 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Other: underwent implantation of dbs | 1 |
| Withdrew: Other: scheduled dbs surgery | 1 |
| Withdrew: Other: prolonged hospitalization | 1 |
| Withdrew: Other: patches would not stick d/t sweat | 1 |
| Withdrew: Other: neupro given in hospital | 1 |
| Withdrew: Other: disease progression | 1 |
| Withdrew: Other: as per sponsor | 8 |
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
| Subjects | Rotigotine |
|---|---|
| Number of Subjects With at Least One Adverse Event During This Open-label Extension Study | 170 |
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
| Subjects | Rotigotine |
|---|---|
| Number of Subjects Who Withdrew From the Trial Due to an Adverse Event | 48 |
The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. The total ESS score is the sum of 8 item-scores and can range between 0 and 24. The higher the score, the higher the person's level of daytime sleepiness.
| Score on a scale | Rotigotine |
|---|---|
| Visit 6 (post year 1) (n=164) | 9.3 ± 5.6 |
| Visit 10 (post year 2) (n=164) | 10.0 ± 5.9 |
| Visit 14 (post year 3) (n=164) | 10.3 ± 6.1 |
| End of Treatment (n=182) | 10.1 ± 5.9 |
Collected over up to four years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rotigotine | — | 45/186 (24.2%) | 136/186 (73.1%) |
| Event | Rotigotine |
|---|---|
| OsteoarthritisMusculoskeletal and connective tissue disorders | 3/186 |
| Parkinson's diseaseNervous system disorders | 3/186 |
| CellulitisInfections and infestations | 2/186 |
| FallInjury, poisoning and procedural complications | 2/186 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 2/186 |
| ParkinsonismNervous system disorders | 2/186 |
| SyncopeNervous system disorders | 2/186 |
| AnaemiaBlood and lymphatic system disorders | 1/186 |
| Angina pectorisCardiac disorders | 1/186 |
| Myocardial infarctionCardiac disorders | 1/186 |
| Event | Rotigotine |
|---|---|
| SomnolenceNervous system disorders | 52/186 |
| Oedema peripheralGeneral disorders | 36/186 |
| FallInjury, poisoning and procedural complications | 29/186 |
| Application site erythemaGeneral disorders | 24/186 |
| InsomniaPsychiatric disorders | 24/186 |
| NauseaGastrointestinal disorders | 21/186 |
| Back painMusculoskeletal and connective tissue disorders | 21/186 |
| DepressionPsychiatric disorders | 19/186 |
| DizzinessNervous system disorders | 18/186 |
| Application site pruritusGeneral disorders | 16/186 |
| Age, Categorical(Participants) | Rotigotine |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 94 |
| >=65 years | 92 |
| Age, Continuous(years) | Rotigotine |
|---|---|
| Mean | 62.5 ± 10.4 |
| Sex: Female, Male(Participants) | Rotigotine |
|---|---|
| Female | 60 |
| Male | 126 |
| Region of Enrollment(participants) | Rotigotine |
|---|---|
| United States | 80 |
| Spain | 9 |
| Austria | 4 |
| South Africa | 22 |
| Israel | 20 |
| Germany | 22 |
| United Kingdom | 20 |
| Italy | 9 |
This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Rotigotine