Long-term Open-label Trial in Idiopathic Restless Legs Syndrome (RLS)
Primary Purpose
Restless Legs Syndrome
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Rotigotine
Sponsored by
About this trial
This is an interventional treatment trial for Restless Legs Syndrome focused on measuring Rotigotine, Neupro®
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)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rotigotine
Arm Description
Rotigotine trans-dermal patch
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00498186
Brief Title
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
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Restless Legs Syndrome
Keywords
Rotigotine, Neupro®
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
295 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rotigotine
Arm Type
Experimental
Arm Description
Rotigotine trans-dermal patch
Intervention Type
Drug
Intervention Name(s)
Rotigotine
Other Intervention Name(s)
Neupro®
Intervention Description
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)
Primary Outcome Measure Information:
Title
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.
Description
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
Secondary Outcome Measure Information:
Title
Number of Subjects Who Withdrew From the Trial Due to an Adverse Event During the 5-year Open Label Extension
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
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
ZIP/Postal Code
35039
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
State/Province
Valencia
Country
Spain
City
Barcelona
Country
Spain
City
Madrid
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
18753003
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.
Results Reference
result
PubMed Identifier
20920156
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.
Results Reference
result
PubMed Identifier
21705273
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.
Results Reference
result
PubMed Identifier
23256574
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.
Results Reference
derived
PubMed Identifier
23009552
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.
Results Reference
derived
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
Long-term Open-label Trial in Idiopathic Restless Legs Syndrome (RLS)
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