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

NCT ID: NCT00498186

Last Updated: 2014-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 295 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-07-31
• Study Completion Date: 2009-04-30

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).

Conditions

Restless Legs Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rotigotine

Rotigotine trans-dermal patch

Group Type: EXPERIMENTAL

Rotigotine

Intervention Type: DRUG

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)

Interventions

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)

Intervention Type: DRUG

Other Intervention Names

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Locations

Innsbruck, , Austria

Bamberg, , Germany

Berlin, , Germany

Bielefeld, , Germany

Gelsenkirchen, , Germany

Gera, , Germany

Halle, , Germany

Jena, , Germany

Kassel, , Germany

Köthen, , Germany

Marburg, , Germany

Mittweida, , Germany

München, , Germany

Neubrandenburg, , Germany

Oldenburg, , Germany

Regensburg, , Germany

Schwalmstadt-Treysa, , Germany

Schwerin, , Germany

Tuttlingen, , Germany

Ulm, , Germany

Unterhaching, , Germany

Alzira, Valencia, Spain

Barcelona, , Spain

Madrid, , Spain

Countries

Austria; Germany; Spain

References

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.

Reference Type: RESULT

PMID: 18753003 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20920156 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21705273 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23256574 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23009552 (View on PubMed)

Related Links

http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

SP0710

Identifier Type: -

Identifier Source: org_study_id