Phase 2
N=295
Long-term Open-label Trial in Idiopathic Restless Legs Syndrome (RLS)
Restless Legs Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00498186 ↗Enrolled (actual)
295
Serious AEs
26.8%
Results posted
Apr 2010
Primary outcome: 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. — 273 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Rotigotine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- UCB Pharma
- Primary completion
- Apr 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
273 | — |
| SECONDARY Number of Subjects Who Withdrew From the Trial Due to an Adverse Event During the 5-year Open Label Extension |
93 | — |
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).
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT00498186). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.