Restless Legs Syndrome
Conditions
Keywords
Rotigotine, Neupro®
Brief summary
This is a multi-center, open-label extension trial conducted at the same European sites that participated in trial SP 709 (NCT00243217). The trial is designed to collect long-term safety and tolerability, efficacy correlates, and quality of life data in subjects with idiopathic Restless Leg Syndrome (RLS). The duration of treatment is approximately 5 years. Subject will be up-titrated to their optimal dose (administration of 1 patch per day, 5 different doses and patch sizes).
Interventions
DRUGRotigotine
Rotigotine transdermal patches once daily: 2.5cm2 (0.5mg/24 hours) 5cm2 (1mg/24 hours) 10cm2 (2mg/24 hours) 15cm2 (3mg/24 hours) 20cm2 (4mg/24 hours)
Sponsors
UCB Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Subject has completed the preceding trial SP709 (NCT00243217)
Exclusion criteria
* Subject did suffer from a serious adverse event during trial SP709 (NCT00243217) which is ongoing at the end of that trial and is assessed to be related to the study medication by the investigator and/or the Sponsor * Sleep disturbances * Further clinically relevant concomitant diseases such as polyneuropathy, akathisia, claudication, varicosis, muscle fasciculation, painful legs and moving toes, or radiculopathy * Other central nervous diseases * One psychotic episode since start of study SP709 * Any medical or psychiatric condition, which in the opinion of the investigator can jeopardize or would compromise the subject's ability to participate in this trial * Clinically relevant cardiac dysfunction and arrhythmias * The subject has at entry in study SP710, a QTc interval ≥ 500 msec and/or a QTc interval which has increased by ≥ 60 msec as compared to the average baseline (Visit 2) QTc interval of study SP709 * Subject has clinically relevant renal dysfunction (serum creatine ≥ 2.0 mg/dl) * Subject has clinically relevant hepatic dysfunction (total bilirubin \> 2.0 mg/dl or ALT and/or AST greater than two times the upper limit of the reference range * Subject has a newly diagnosed or relapsing neoplastic disease since the start of study SP709 * Subject has a known hypersensitivity to any components of the trial medication or comparative drugs as stated in this protocol * Subject needs drugs prohibited in the course of this trial: neuroleptics, bupidine, hypnotics, antidepressants, anxiolytic drugs, anticonvulsive therapy, psychostimulatory drugs, other L-Dopa or dopamine agonist therapy, opioids, benzodiazepines, MAO inhibitors, sedative antihistamines, amphetamines * Subject is abusing alcohol or drug since start of SP709 * Subject is pregnant or nursing or woman of child-bearing potential who is not surgically sterile, two years postmenopausal, or does not practice two combined methods of contraception, unless sexually abstinent * Subject pursues shift work or is subject to other continuous non-disease-related life conditions which do not allow regular sleep at night * Subject has clinically relevant vasculopathies (eg, varix or arteriosclerosis) * Subject has significant skin hypersensitivity to adhesive or other transdermals or recent unresolved contact dermatitis * Subject has symptomatic orthostatic hypotension, or a systolic blood pressure (SBP) less tham 105mmHg and/or a drop in SBP of \> 20mmHg or a drop of \> 10mmHg in diastolic BP (DBP) on standing at baseline visit (Visit 1)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With at Least One Adverse Event, as Reported Spontaneously by the Subject or Observed by the Investigator, During the 5-year Open-label Extension. | Up to 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 During the 5-year Open Label Extension | Up to five years | Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment. |
Countries
Austria, Germany, Spain
Participant flow
Recruitment details
A total of 295 subjects belong to the Enrolled Set (ES) and all of them received at least one dose of trial medication, so they all belong to the Safety Set (SS).
Pre-assignment details
Participant Flow information and Baseline Characteristics belong to the Safety Set (SS).
Participants by arm
| Arm | Count |
|---|---|
| Rotigotine Rotigotine trans-dermal patch | 295 |
| Total | 295 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 89 |
| Overall Study | Lack of Efficacy | 31 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Other | 10 |
| Overall Study | Protocol Violation | 10 |
| Overall Study | Unsatisfactory compliance of subject | 12 |
| Overall Study | Withdrawal by Subject | 18 |
Baseline characteristics
| Characteristic | Rotigotine |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 87 Participants |
| Age, Categorical Between 18 and 65 years | 208 Participants |
| Age, Continuous | 58.3 years STANDARD_DEVIATION 10.1 |
| Body Mass Index (BMI) | 26.37 kg/ m^2 STANDARD_DEVIATION 3.84 |
| Height | 167.5 cm STANDARD_DEVIATION 8.3 |
| Sex: Female, Male Female | 196 Participants |
| Sex: Female, Male Male | 99 Participants |
| Weight | 74.21 kilogram (kg) STANDARD_DEVIATION 13.19 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 272 / 295 |
| serious Total, serious adverse events | 79 / 295 |
Outcome results
Primary
Number of Subjects With at Least One Adverse Event, as Reported Spontaneously by the Subject or Observed by the Investigator, During the 5-year Open-label Extension.
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Time frame: Up to five years
Population: Of the 295 subjects who entered the study, 295 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, as Reported Spontaneously by the Subject or Observed by the Investigator, During the 5-year Open-label Extension. | 273 participants |
Secondary
Number of Subjects Who Withdrew From the Trial Due to an Adverse Event During the 5-year Open Label Extension
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Time frame: Up to five years
Population: Of the 295 subjects who entered the study, 295 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 During the 5-year Open Label Extension | 93 participants |