Long-term Open-label Trial in Idiopathic Restless Legs Syndrome (RLS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00498186
Recruitment Status : Completed
First Posted : July 9, 2007
Results First Posted : April 13, 2010
Last Update Posted : October 2, 2014
Information provided by (Responsible Party):
UCB Pharma

July 6, 2007
July 9, 2007
March 23, 2010
April 13, 2010
October 2, 2014
July 2003
April 2009   (Final data collection date for primary outcome measure)
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. [ Time Frame: 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.
  • Adverse events
  • Subject withdrawal due to adverse events and time to such withdrawal after start of long-term therapy.
  • Clinically significant differences in hematology, blood chemistry, urine analysis parameters, 12-lead ECGs, vital signs, physical and neurological examination findings
Complete list of historical versions of study NCT00498186 on Archive Site
Number of Subjects Who Withdrew From the Trial Due to an Adverse Event During the 5-year Open Label Extension [ Time Frame: 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.
  • Rotigotine drug exposure
  • Epworth Sleepiness Scale to evaluate daytime tiredness / sleep attacks
  • Global rating of tolerability
  • RLS-6 Rating Scale
Not Provided
Not Provided
Long-term Open-label Trial in Idiopathic Restless Legs Syndrome (RLS)
An Open-label Extension Trial to Determine Safety and Tolerability of Long-term Transdermal Application of Rotigotine in Subjects With Idiopathic Restless Legs Syndrome
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).
Not Provided
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Restless Legs Syndrome
Drug: Rotigotine

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)

Other Name: Neupro®
Experimental: Rotigotine
Rotigotine trans-dermal patch
Intervention: Drug: Rotigotine

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
April 2009
April 2009   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany,   Spain
Not Provided
Not Provided
UCB Pharma
UCB Pharma
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB Pharma
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP