A Phase 3 interventional study of Rotigotine in Parkinson's Disease, sponsored by UCB Pharma. Completed at 41 sites in 2 countries. Open to participants aged 31 Years and older. Per ClinicalTrials.gov, last updated 2014-10-02.
Sponsored by UCB Pharma · Phase 3, Interventional, and Treatment
The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of the Rotigotine patch in subjects with advanced-stage idiopathic Parkinson's Disease.
This is the open-label extension to the randomized, double-blind, placebo-controlled SP650 trial that assessed the efficacy and safety and tolerability of the Rotigotine patch in subjects with advanced-stage idiopathic Parkinson's Disease who are not well-controlled on Levodopa.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 258 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →UCB Pharma is the lead sponsor of 238 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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: During the first year: The maximum Rotigotine dose allowed is 6 mg/24 hours. After the first year: Allowed dose increase of Rotigotine up to a maximum of 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: 6 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: 6 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 11 (end of year 1), Visit 15 (end of year 2), Visit 19 (end of year 3), Visit 23 (end of year 4), Visit 27 (end of year 5), Visit 31 (end of year 6), End of Treatment (last study visit or early withdrawal visit)
A multicenter Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advanced-Stage Parkinson's Disease with 41 sites in United States and Canada from August 2002 to December 2008
| Milestone | Rotigotine |
|---|---|
| Started | 258 |
| Completed | 0 |
| Not completed | 258 |
| Withdrew: Major protocol violation | 2 |
| Withdrew: Lack of efficacy | 12 |
| Withdrew: Adverse event | 68 |
| Withdrew: Unsatisfactory compliance of subject | 11 |
| Withdrew: Subject withdrew consent | 35 |
| Withdrew: Study ended per sponsor | 115 |
| Withdrew: Lost to follow-up | 6 |
| Withdrew: Other: patient went off patch (hospital) | 1 |
| Withdrew: Other: subject moved to seattle | 1 |
| Withdrew: Other: subject admitted to nursing home | 1 |
| Withdrew: Other: study terminated per investigator | 2 |
| Withdrew: Other: sponsor closure of study | 1 |
| Withdrew: Other: site terminated participation | 1 |
| Withdrew: Other: patient wants prescription neupro | 1 |
| Withdrew: Other: loss of drivers license | 1 |
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 | 258 |
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. | 68 |
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 11 (end of year 1) (n=254) | 8.6 ± 4.9 |
| Visit 15 (end of year 2) (n=254) | 8.9 ± 4.9 |
| Visit 19 (end of year 3) (n=254) | 9.3 ± 5.1 |
| Visit 23 (end of year 4) (n=254) | 9.8 ± 5.2 |
| Visit 27 (end of year 5) (n=254) | 9.7 ± 5.3 |
| Visit 31 (end of year 6) (n=254) | 10.0 ± 5.4 |
| End of Treatment (n=258) | 10.0 ± 5.4 |
Collected over Up to 6 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rotigotine | — | 165/258 (64%) | 253/258 (98.1%) |
| Event | Rotigotine |
|---|---|
| Parkinson's diseaseNervous system disorders | 25/258 |
| FallInjury, poisoning and procedural complications | 13/258 |
| Chest painGeneral disorders | 10/258 |
| DehydrationMetabolism and nutrition disorders | 9/258 |
| Urinary tract infectionInfections and infestations | 8/258 |
| Cerebrovascular accidentNervous system disorders | 8/258 |
| SyncopeNervous system disorders | 8/258 |
| HallucinationPsychiatric disorders | 8/258 |
| Cardiac failure congestiveCardiac disorders | 7/258 |
| CellulitisInfections and infestations | 7/258 |
| Event | Rotigotine |
|---|---|
| SomnolenceNervous system disorders | 150/258 |
| FallInjury, poisoning and procedural complications | 100/258 |
| Oedema peripheralGeneral disorders | 80/258 |
| NauseaGastrointestinal disorders | 61/258 |
| DizzinessNervous system disorders | 61/258 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 60/258 |
| ConstipationGastrointestinal disorders | 58/258 |
| InsomniaPsychiatric disorders | 56/258 |
| Urinary tract infectionInfections and infestations | 55/258 |
| HallucinationPsychiatric disorders | 54/258 |
| Age, Categorical(Participants) | Rotigotine |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 98 |
| >=65 years | 160 |
| Age, Continuous(years) | Rotigotine |
|---|---|
| Mean | 66.4 ± 9.6 |
| Sex: Female, Male(Participants) | Rotigotine |
|---|---|
| Female | 85 |
| Male | 173 |
| Region of Enrollment(participants) | Rotigotine |
|---|---|
| United States | 243 |
| Canada | 15 |
This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.
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