Idiopathic 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 rotigotine in subjects with idiopathic PD.
Detailed description
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.
Interventions
DRUGRotigotine
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.
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 treatment in one of the SP824 (NCT00242008), SP825 (NCT00243971), or SP826 (NCT00243945) trials
Exclusion criteria
* Subjects who had an ongoing serious adverse event from the previous OLE 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 | four 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 | four 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 6 (post year 1), Visit 10 (post year 2), Visit 14 (post year 3), 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
Austria, Germany, Israel, Italy, South Africa, Spain, United Kingdom, United States
Participant flow
Recruitment details
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.
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. | 186 |
| Total | 186 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 48 |
| Overall Study | Important protocol violation | 2 |
| Overall Study | Lack of Efficacy | 15 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Other: As Per Sponsor | 8 |
| Overall Study | Other: Disease Progression | 1 |
| Overall Study | Other: Neupro Given In Hospital | 1 |
| Overall Study | Other: Patches Would Not Stick D/T Sweat | 1 |
| Overall Study | Other: Prolonged Hospitalization | 1 |
| Overall Study | Other: Scheduled DBS Surgery | 1 |
| Overall Study | Other: Underwent Implantation Of DBS | 1 |
| Overall Study | Subject withdrew consent | 15 |
Baseline characteristics
| Characteristic | Rotigotine |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 92 Participants |
| Age, Categorical Between 18 and 65 years | 94 Participants |
| Age, Continuous | 62.5 years STANDARD_DEVIATION 10.4 |
| Region of Enrollment Austria | 4 participants |
| Region of Enrollment Germany | 22 participants |
| Region of Enrollment Israel | 20 participants |
| Region of Enrollment Italy | 9 participants |
| Region of Enrollment South Africa | 22 participants |
| Region of Enrollment Spain | 9 participants |
| Region of Enrollment United Kingdom | 20 participants |
| Region of Enrollment United States | 80 participants |
| Sex: Female, Male Female | 60 Participants |
| Sex: Female, Male Male | 126 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 136 / 186 |
| serious Total, serious adverse events | 45 / 186 |
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: four years
Population: Of the 186 subjects who entered the study, 186 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 | 170 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 6 (post year 1), Visit 10 (post year 2), Visit 14 (post year 3), End of Treatment (last study visit or early withdrawal visit)
Population: Of the 186 subjects who entered the study, 186 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 6 (post year 1) (n=164) | 9.3 Score on a scale | Standard Deviation 5.6 |
| Rotigotine | Mean Epworth Sleepiness Scale Score During the Open-label Extension. | Visit 10 (post year 2) (n=164) | 10.0 Score on a scale | Standard Deviation 5.9 |
| Rotigotine | Mean Epworth Sleepiness Scale Score During the Open-label Extension. | Visit 14 (post year 3) (n=164) | 10.3 Score on a scale | Standard Deviation 6.1 |
| Rotigotine | Mean Epworth Sleepiness Scale Score During the Open-label Extension. | End of Treatment (n=182) | 10.1 Score on a scale | Standard Deviation 5.9 |
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: four years
Population: Of the 186 subjects who entered the study, 186 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 | 48 Subjects |