Advanced 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 advanced-stage idiopathic Parkinson's disease
Detailed description
This is the open-label extension to the randomized, double-blind, placebo-and active controlled SP515 (NCT00244387) trial that assessed the efficacy and safety and tolerability of the Rotigotine patch in subjects with advanced-stage idiopathic Parkinson's Disease that were not well-controlled on levodopa
Interventions
DRUGRotigotine
Rotigotine trans-dermal patches once daily: 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)
Sponsors
UCB Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
31 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects who have completed four months of maintenance treatment in the SP515 (NCT00244387) double-blind trial
Exclusion criteria
* Subjects who had an ongoing serious adverse event from SP515 (NCT00244387) 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 | five 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 | five 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 13 (end of year 1), Visit 17 (end of year 2), Visit 21 (end of year 3), Visit 25(end of year 4) | 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, Croatia, Czechia, Finland, France, Germany, Hungary, Israel, Italy, New Zealand, Norway, Poland, South Africa, Spain, Sweden, United Kingdom
Participant flow
Recruitment details
An Open-Label Extension to the Double-Blind SP515 (NCT00244387) Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects with Advanced-Stage Idiopathic Parkinson's Disease who are not well controlled on L-Dopa from August 2004 to December 2008
Participants by arm
| Arm | Count |
|---|---|
| Rotigotine Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours. | 395 |
| Total | 395 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 76 |
| Overall Study | Lack of Efficacy | 29 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Major Protocol Violation | 4 |
| Overall Study | Other: Admin Request from the Sponsor | 3 |
| Overall Study | Other: As Required by Local EC | 2 |
| Overall Study | Other: DX Changed - Parkinsons to PSNP | 1 |
| Overall Study | Other: Patient is Going to Have DBS | 1 |
| Overall Study | Other: Patients + Investigator Agreement | 1 |
| Overall Study | Other: Pat Pending Surgery for PD | 1 |
| Overall Study | Other: Severe Dementia Unable Sign PIC | 1 |
| Overall Study | Other: Sponsors Request | 10 |
| Overall Study | Other: Sponsor Stopped Study | 12 |
| Overall Study | Other: Sponsor Termination at Site | 1 |
| Overall Study | Other: Sponsor Termination/Commercial RX | 1 |
| Overall Study | Other: Tired Of Clinical Trial Process | 1 |
| Overall Study | Subject withdrew consent | 51 |
| Overall Study | Unsatisfactory compliance of subject | 7 |
Baseline characteristics
| Characteristic | Rotigotine |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 212 Participants |
| Age, Categorical Between 18 and 65 years | 183 Participants |
| Age, Continuous | 64.4 years STANDARD_DEVIATION 9.2 |
| Region of Enrollment Australia | 30 participants |
| Region of Enrollment Austria | 6 participants |
| Region of Enrollment Croatia | 27 participants |
| Region of Enrollment Czech Republic | 50 participants |
| Region of Enrollment Finland | 8 participants |
| Region of Enrollment France | 9 participants |
| Region of Enrollment Germany | 4 participants |
| Region of Enrollment Hungary | 11 participants |
| Region of Enrollment Israel | 22 participants |
| Region of Enrollment Italy | 33 participants |
| Region of Enrollment New Zealand | 16 participants |
| Region of Enrollment Norway | 8 participants |
| Region of Enrollment Poland | 65 participants |
| Region of Enrollment South Africa | 52 participants |
| Region of Enrollment Spain | 35 participants |
| Region of Enrollment Sweden | 9 participants |
| Region of Enrollment United Kingdom | 10 participants |
| Sex: Female, Male Female | 144 Participants |
| Sex: Female, Male Male | 251 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 305 / 395 |
| serious Total, serious adverse events | 148 / 395 |
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: five years
Population: Of the 395 subjects who entered the study, 395 are included in this summary based on the Safety Set (SS).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotigotine | Number of Subjects With at Least One Adverse Event During This Open-label Extension Study | 357 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 13 (end of year 1), Visit 17 (end of year 2), Visit 21 (end of year 3), Visit 25(end of year 4)
Population: Of the 395 subjects who entered the study, 395 are included in this summary based on the Safety Set (SS). Last observation carried forward (LOCF) was utilized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rotigotine | Mean Epworth Sleepiness Scale Score During the Open-label Extension | Visit 13 (end of year 1) (n=377) | 7.4 Score on a scale | Standard Deviation 4.7 |
| Rotigotine | Mean Epworth Sleepiness Scale Score During the Open-label Extension | Visit 17 (end of year 2) (n=377) | 7.8 Score on a scale | Standard Deviation 5.1 |
| Rotigotine | Mean Epworth Sleepiness Scale Score During the Open-label Extension | Visit 21 (end of year 3) (n=377) | 8.0 Score on a scale | Standard Deviation 5.1 |
| Rotigotine | Mean Epworth Sleepiness Scale Score During the Open-label Extension | Visit 25 (end of year 4) (n=377) | 8.3 Score on a scale | Standard Deviation 5.2 |
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: five years
Population: Of the 395 subjects who entered the study, 395 are included in this summary based on the Safety Set (SS).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotigotine | Number of Subjects Who Withdrew From the Trial Due to an Adverse Event | 76 Subjects |