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

NCT00498186 | Completed Phase 2 Results

• 1 other identifier: SP0710
• Study Type: interventional
• Target: 295
• Locations: 3 countries
• Sites: 24

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

Keywords

Rotigotine; Neupro®

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to five years

Secondary Outcomes (1)

• Number of Subjects Who Withdrew From the Trial Due to an Adverse Event During the 5-year Open Label Extension

  Up to five years

Study Arms (1)

Rotigotine

EXPERIMENTAL

Rotigotine trans-dermal patch

Drug: Rotigotine

Interventions

Rotigotine 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)

Also known as: Neupro®

Rotigotine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has completed the preceding trial SP709 (NCT00243217)

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Pharma: lead

Study Sites (24)

Unknown Facility

Innsbruck, Austria

Location

Unknown Facility

Bamberg, Germany

Location

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Bielefeld, Germany

Location

Unknown Facility

Gelsenkirchen, Germany

Location

Unknown Facility

Gera, Germany

Location

Unknown Facility

Halle, Germany

Location

Unknown Facility

Jena, Germany

Location

Unknown Facility

Kassel, Germany

Location

Unknown Facility

Köthen, Germany

Location

Unknown Facility

Marburg, 35039, Germany

Location

Unknown Facility

Mittweida, Germany

Location

Unknown Facility

München, Germany

Location

Unknown Facility

Neubrandenburg, Germany

Location

Unknown Facility

Oldenburg, Germany

Location

Unknown Facility

Regensburg, Germany

Location

Unknown Facility

Schwalmstadt-Treysa, Germany

Location

Unknown Facility

Schwerin, Germany

Location

Unknown Facility

Tuttlingen, Germany

Location

Unknown Facility

Ulm, Germany

Location

Unknown Facility

Unterhaching, Germany

Location

Unknown Facility

Alzira, Valencia, Spain

Location

Unknown Facility

Barcelona, Spain

Location

Unknown Facility

Madrid, Spain

Location

Related Publications (5)

• 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.

  PMID: 18753003 RESULT

• 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.

  PMID: 20920156 RESULT

• 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.

  PMID: 21705273 RESULT

• 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.

  PMID: 23256574 DERIVED

• 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.

  PMID: 23009552 DERIVED

Related Links

• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

rotigotine

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Results Point of Contact

• Title: UCB Clinical Trial Call Center
• Organization: UCB

+1 877 822 9493 (UCB)

Study Officials

• UCB Clinical Trial Call Center

  +1 877 822 9493 (UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2007
• First Posted: July 9, 2007
• Study Start: July 1, 2003
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: October 2, 2014
• Results First Posted: April 13, 2010

Record last verified: 2011-10

Locations

AU (1); DE (20); ES (3)