Clinical trial NCT00498186: Long-term Open-label Trial in Idiopathic Restless Legs Syndrome (RLS)
Official title: An Open-label Extension Trial to Determine Safety and Tolerability of Long-term Transdermal Application of Rotigotine in Subjects With Idiopathic Restless Legs Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Restless Legs Syndrome
Keywords: Rotigotine
Neupro®
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2007-07-09
Enrollment: 295
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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)

Primary outcomes:
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.
timeFrame: Up to five years
Secondary outcomes:
measure: Number of Subjects Who Withdrew From the Trial Due to an Adverse Event During the 5-year Open Label Extension
timeFrame: Up to five years
Other outcomes:
Locations:
city: Innsbruck
country: Austria
city: Bamberg
country: Germany
city: Berlin
country: Germany
city: Bielefeld
country: Germany
city: Gelsenkirchen
country: Germany
city: Gera
country: Germany
city: Halle
country: Germany
city: Jena
country: Germany
city: Kassel
country: Germany
city: Köthen
country: Germany
city: Marburg
country: Germany
city: Mittweida
country: Germany
city: München
country: Germany
city: Neubrandenburg
country: Germany
city: Oldenburg
country: Germany
city: Regensburg
country: Germany
city: Schwalmstadt-Treysa
country: Germany
city: Schwerin
country: Germany
city: Tuttlingen
country: Germany
city: Ulm
country: Germany
city: Unterhaching
country: Germany
city: Alcira
country: Spain
state: Valencia
city: Barcelona
country: Spain
city: Madrid
country: Spain
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Oertel WH, Benes H, Garcia-Borreguero D, Geisler P, Hogl B, Trenkwalder C, Tacken I, Schollmayer E, Kohnen R, Stiasny-Kolster K; Rotigotine SP710 Study Group. One year open-label safety and efficacy trial with rotigotine transdermal patch in moderate to severe idiopathic restless legs syndrome. Sleep Med. 2008 Dec;9(8):865-73. doi: 10.1016/j.sleep.2008.04.012. Epub 2008 Aug 26.
citation: Hogl B, Oertel WH, Stiasny-Kolster K, Geisler P, Benes H, Garcia-Borreguero D, Trenkwalder C, Poewe W, Schollmayer E, Kohnen R. Treatment of moderate to severe restless legs syndrome: 2-year safety and efficacy of rotigotine transdermal patch. BMC Neurol. 2010 Sep 28;10:86. doi: 10.1186/1471-2377-10-86.
citation: Oertel W, Trenkwalder C, Benes H, Ferini-Strambi L, Hogl B, Poewe W, Stiasny-Kolster K, Fichtner A, Schollmayer E, Kohnen R, Garcia-Borreguero D; SP710 study group. Long-term safety and efficacy of rotigotine transdermal patch for moderate-to-severe idiopathic restless legs syndrome: a 5-year open-label extension study. Lancet Neurol. 2011 Aug;10(8):710-20. doi: 10.1016/S1474-4422(11)70127-2. Epub 2011 Jun 24.
citation: Dohin E, Hogl B, Ferini-Strambi L, Schollmayer E, Fichtner A, Bauer L, Garcia-Borreguero D. Safety and efficacy of rotigotine transdermal patch in patients with restless legs syndrome: a post-hoc analysis of patients taking 1 - 3 mg/24 h for up to 5 years. Expert Opin Pharmacother. 2013 Jan;14(1):15-25. doi: 10.1517/14656566.2013.758251. Epub 2012 Dec 21.
citation: Hogl B, Oertel WH, Schollmayer E, Bauer L. Transdermal rotigotine for the perioperative management of restless legs syndrome. BMC Neurol. 2012 Sep 25;12:106. doi: 10.1186/1471-2377-12-106.