Parkinson's Disease
Conditions
Keywords
Neupro®, Rotigotine, Parkinson's Disease
Brief summary
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.
Interventions
DRUGRotigotine
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
Sponsors
UCB Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Completion of trial SP889
Exclusion criteria
* Ongoing serious adverse event assessed as related to trial medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in UPDRS III Score at Week 13 (End of Maintenance) | Baseline (baseline SP915) and 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. |
| Change From Baseline in Parkinson Disease Sleep Scale (PDSS) at Week 13 (End of Maintenance) | Baseline (baseline SP889 NCT00474058) and 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS) at Week 13 (End of Maintenance) | Baseline (baseline SP889 NCT00474058) and 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. |
| Change From Baseline in Number of Nocturias at Week 13 (End of Maintenance) | Baseline (baseline SP889 NCT00474058) and 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. |
Countries
Australia, Finland, Germany, Hungary, Italy, New Zealand, Poland, South Africa, Spain, United Kingdom, United States
Participant flow
Recruitment details
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).
Pre-assignment details
Participant Flow information belong to the Enrolled Set (ES). Baseline Characteristics are described for the Full Analysis Set (FAS).
Participants by arm
| Arm | Count |
|---|---|
| Rotigotine Rotigotine Transdermal Patch | 83 |
| Total | 83 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 11 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Rotigotine |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 49 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants |
| Age, Continuous | 66.2 years STANDARD_DEVIATION 10.4 |
| Body Mass Index (BMI) | 26.928 kg/ m^2 STANDARD_DEVIATION 4.219 |
| Height | 170.1 cm STANDARD_DEVIATION 10.58 |
| L- Dopa Advanced | 73 participants |
| L- Dopa Early | 10 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants |
| Race (NIH/OMB) White | 71 Participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 57 Participants |
| Weight | 78.3 kg STANDARD_DEVIATION 16.6 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 55 / 84 |
| serious Total, serious adverse events | 16 / 84 |
Outcome results
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.
Time frame: Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance)
Population: Full Analysis Set (FAS).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change From Baseline in Parkinson Disease Sleep Scale (PDSS) at Week 13 (End of Maintenance) | -5.8 units on a scale | Standard Deviation 7.8 |
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.
Time frame: Baseline (baseline SP915) and week 13 (End of maintenance)
Population: Full Analysis Set (FAS).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change From Baseline in UPDRS III Score at Week 13 (End of Maintenance) | -5.8 units on a scale | Standard Deviation 9.4 |
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.
Time frame: Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance)
Population: Full Analysis Set (FAS).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change From Baseline in Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS) at Week 13 (End of Maintenance) | -1.5 units on a scale | Standard Deviation 2.1 |
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.
Time frame: Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance)
Population: Full Analysis Set (FAS).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change From Baseline in Number of Nocturias at Week 13 (End of Maintenance) | -0.4 Nocturias | Standard Deviation 1.2 |