Early Stage Parkinson's Disease
Conditions
Keywords
Rotigotine, Neupro®
Brief summary
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 early-stage idiopathic Parkinson's disease
Detailed description
This is the open-label extension to the randomized, double-blind, placebo- and ropinirole-controlled SP513 trial that assessed the efficacy and safety and tolerability of the Rotigotine patch in subjects with early-stage idiopathic Parkinson's Disease
Interventions
DRUGRotigotine
Rotigotine trans-dermal patches, once daily: 10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours); 50 cm2 (10 mg/24 hours); 60 cm2 (12 mg/24 hours); 70 cm2 (14 mg/24 hours); 80 cm2 (16 mg/24 hours); Optimal dosing: During the first year: The maximum Rotigotine dose allowed is 8 mg/24 hours. After the first year: allowed dose increase of rotigotine up to a maximum of 16 mg/24 hours.
Sponsors
UCB Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects who have completed six months of maintenance treatment in the SP513 double-blind trial
Exclusion criteria
* Subjects who had an ongoing serious adverse event from SP513 double-blind trial that was assessed as related to study medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With at Least One Adverse Event During This Open-label Extension Study | six years | Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Who Withdrew From the Trial Due to an Adverse Event | six years | Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment. |
| Mean Epworth Sleepiness Scale Score During the Open-label Extension | Visit 10 (end of year 1), Visit 14 (end of year 2), Visit 18 (end of year 3), Visit 22 (end of year 4), Visit 26 (end of year 5), Visit 30 (end of year 6), End of Treatment (last study visit or early withdrawal visit) | 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. |
Countries
Australia, Austria, Belgium, Croatia, Czechia, Finland, France, Germany, Hungary, Israel, Italy, Netherlands, New Zealand, Norway, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom
Participant flow
Recruitment details
An Open-Label Extension to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects with Early-Stage Idiopathic Parkinson's Disease from August 2002 to December 2008
Pre-assignment details
One subject was excluded from the safety set because he withdrew consent prior to receiving any Open Label study medication.
Participants by arm
| Arm | Count |
|---|---|
| Rotigotine Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 8 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours. | 380 |
| Total | 380 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 93 |
| Overall Study | Lack of Efficacy | 22 |
| Overall Study | Lost to Follow-up | 17 |
| Overall Study | Other: Diagnosis No Longer Idiopathic Pd | 1 |
| Overall Study | Other: Inv Switched Dopamine Agonist | 1 |
| Overall Study | Other: Patient Leaving For Israel | 1 |
| Overall Study | Other: Patient Stopped Due To Moving | 1 |
| Overall Study | Other: Pt Moved To Australia | 1 |
| Overall Study | Other: Spouse Withdrew Consent | 1 |
| Overall Study | Study ended per sponsor | 197 |
| Overall Study | Subject withdrew consent | 43 |
| Overall Study | Unsatisfactory compliance of subject | 3 |
Baseline characteristics
| Characteristic | Rotigotine |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 165 Participants |
| Age, Categorical Between 18 and 65 years | 215 Participants |
| Age, Continuous | 61.6 years STANDARD_DEVIATION 10 |
| Region of Enrollment Australia | 7 participants |
| Region of Enrollment Austria | 12 participants |
| Region of Enrollment Belgium | 12 participants |
| Region of Enrollment Croatia | 17 participants |
| Region of Enrollment Czech Republic | 44 participants |
| Region of Enrollment Finland | 16 participants |
| Region of Enrollment France | 10 participants |
| Region of Enrollment Germany | 7 participants |
| Region of Enrollment Hungary | 17 participants |
| Region of Enrollment Israel | 30 participants |
| Region of Enrollment Italy | 9 participants |
| Region of Enrollment Netherlands | 5 participants |
| Region of Enrollment New Zealand | 19 participants |
| Region of Enrollment Norway | 4 participants |
| Region of Enrollment Poland | 65 participants |
| Region of Enrollment South Africa | 42 participants |
| Region of Enrollment Spain | 10 participants |
| Region of Enrollment Sweden | 12 participants |
| Region of Enrollment Switzerland | 4 participants |
| Region of Enrollment United Kingdom | 38 participants |
| Sex: Female, Male Female | 150 Participants |
| Sex: Female, Male Male | 230 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 323 / 380 |
| serious Total, serious adverse events | 131 / 380 |
Outcome results
Primary
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: six years
Population: Of the 381 subjects who entered the study, 380 are included in this summary based on the Safety Set (SS). One subject was excluded from the safety set because he withdrew consent prior to receiving any Open Label study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotigotine | Number of Subjects With at Least One Adverse Event During This Open-label Extension Study | 369 Subjects |
Secondary
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 10 (end of year 1), Visit 14 (end of year 2), Visit 18 (end of year 3), Visit 22 (end of year 4), Visit 26 (end of year 5), Visit 30 (end of year 6), End of Treatment (last study visit or early withdrawal visit)
Population: Of the 380 subjects who are included in the Safety Set (SS), 5 subjects discontinued prior to entering the maintenance phase (n=375), however 2 of these subjects returned for the End of Treatment visit (n=377). Last observation carried forward (LOCF) was utilized for subjects who entered the maintenance phase.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rotigotine | Mean Epworth Sleepiness Scale Score During the Open-label Extension | Visit 10 (end of year 1) (n=375) | 5.8 Score on a scale | Standard Deviation 3.8 |
| Rotigotine | Mean Epworth Sleepiness Scale Score During the Open-label Extension | Visit 14 (end of year 2) (n=375) | 6.2 Score on a scale | Standard Deviation 4.1 |
| Rotigotine | Mean Epworth Sleepiness Scale Score During the Open-label Extension | Visit 18 (end of year 3) (n=375) | 6.7 Score on a scale | Standard Deviation 4.5 |
| Rotigotine | Mean Epworth Sleepiness Scale Score During the Open-label Extension | Visit 22 (end of year 4) (n=375) | 6.7 Score on a scale | Standard Deviation 4.6 |
| Rotigotine | Mean Epworth Sleepiness Scale Score During the Open-label Extension | Visit 26 (end of year 5) (n=375) | 6.7 Score on a scale | Standard Deviation 4.5 |
| Rotigotine | Mean Epworth Sleepiness Scale Score During the Open-label Extension | Visit 30 (end of year 6) (n=375) | 6.8 Score on a scale | Standard Deviation 4.5 |
| Rotigotine | Mean Epworth Sleepiness Scale Score During the Open-label Extension | End of Treatment (n=377) | 6.8 Score on a scale | Standard Deviation 4.5 |
Secondary
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: six years
Population: Of the 381 subjects who entered the study, 380 are included in this summary based on the Safety Set (SS). One subject was excluded from the safety set because he withdrew consent prior to receiving any Open Label study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotigotine | Number of Subjects Who Withdrew From the Trial Due to an Adverse Event | 93 Subjects |