Early-Stage Parkinson's Disease
Conditions
Keywords
Rotigotine
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-controlled SP512 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: 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.
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 six months of maintenance treatment in the SP512 double-blind trial
Exclusion criteria
* Subjects who had an ongoing serious adverse event from SP512 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 | 7 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. | 7 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 9 (end of year 1), Visit 13 (end of year 2), Visit 17 (end of year 3), Visit 21(end of year 4), Visit 25 (end of year 5), Visit 29 (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
Canada, United States
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 June 2002 to November 2008
Pre-assignment details
Subject 10806 received SP512OL study medication at the final visit of SP512DB but never returned to the clinic; this subject is excluded from the Safety Set.
Participants by arm
| Arm | Count |
|---|---|
| Rotigotine Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours. | 216 |
| Total | 216 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 52 |
| Overall Study | Lack of Efficacy | 12 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Major protocol violation | 1 |
| Overall Study | Other: Brain surgery controlled symptoms | 1 |
| Overall Study | Other: House bound; can't get to clinic | 1 |
| Overall Study | Other: PI discretion | 5 |
| Overall Study | Other: Site terminated participation | 2 |
| Overall Study | Other: Subject enrolled in other trial | 1 |
| Overall Study | Other: Subject moving | 3 |
| Overall Study | Study ended per sponsor | 102 |
| Overall Study | Subject withdrew consent | 27 |
| Overall Study | Unsatisfactory compliance of subject | 6 |
Baseline characteristics
| Characteristic | Rotigotine |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 97 Participants |
| Age, Categorical Between 18 and 65 years | 119 Participants |
| Age, Continuous | 63.2 years STANDARD_DEVIATION 10.3 |
| Region of Enrollment Canada | 30 participants |
| Region of Enrollment United States | 186 participants |
| Sex: Female, Male Female | 69 Participants |
| Sex: Female, Male Male | 147 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 206 / 216 |
| serious Total, serious adverse events | 102 / 216 |
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: 7 years
Population: Of the 217 subjects who entered the study, 216 are included in this summary based on the Safety Set (SS). Subject 10806 received SP512OL study medication at the final visit of SP512DB but never returned to the clinic; this subject is excluded from the Safety Set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotigotine | Number of Subjects With at Least One Adverse Event During This Open-label Extension Study | 214 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 9 (end of year 1), Visit 13 (end of year 2), Visit 17 (end of year 3), Visit 21(end of year 4), Visit 25 (end of year 5), Visit 29 (end of year 6), End of Treatment (last study visit or early withdrawal visit)
Population: Of the 217 subjects who entered the study, 216 are included in this summary based on the Safety Set (SS). Subject 10806 received SP512OL study medication at the final visit of SP512DB but never returned to the clinic; this subject is excluded from the Safety Set. 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 9 (end of year 1) (n=209) | 7.3 Score on a scale | Standard Deviation 4.4 |
| Rotigotine | Mean Epworth Sleepiness Scale Score During the Open-label Extension. | Visit 13 (end of year 2) (n=209) | 7.9 Score on a scale | Standard Deviation 4.9 |
| Rotigotine | Mean Epworth Sleepiness Scale Score During the Open-label Extension. | Visit 17 (end of year 3) (n=209) | 8.2 Score on a scale | Standard Deviation 5.2 |
| Rotigotine | Mean Epworth Sleepiness Scale Score During the Open-label Extension. | Visit 21 (end of year 4) (n=209) | 8.4 Score on a scale | Standard Deviation 5 |
| Rotigotine | Mean Epworth Sleepiness Scale Score During the Open-label Extension. | Visit 25 (end of year 5) (n=209) | 8.8 Score on a scale | Standard Deviation 5 |
| Rotigotine | Mean Epworth Sleepiness Scale Score During the Open-label Extension. | Visit 29 (end of year 6) (n=209) | 8.5 Score on a scale | Standard Deviation 5 |
| Rotigotine | Mean Epworth Sleepiness Scale Score During the Open-label Extension. | End of Treatment (n=216) | 9.0 Score on a scale | Standard Deviation 5.4 |
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: 7 years
Population: Of the 217 subjects who entered the study, 216 are included in this summary based on the Safety Set (SS). Subject 10806 received SP512OL study medication at the final visit of SP512DB but never returned to the clinic; this subject is excluded from the Safety Set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotigotine | Number of Subjects Who Withdrew From the Trial Due to an Adverse Event. | 52 subjects |