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

Restless Legs Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00498186
• Other study ID #: SP0710
• Status: Completed
• Phase: Phase 2
• First received: July 6, 2007
• Last updated: September 24, 2014
• Start date: July 2003
• Est. completion date: April 2009

Study information

• Verified date: October 2011
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food SafetyGermany: Federal Institute for Drugs and Medical DevicesSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 295
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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)

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychomotor Agitation
• Restless Legs Syndrome
• Syndrome

Intervention

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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Countries where clinical trial is conducted

Austria,  Germany,  Spain, 

References & Publications (3)

Högl B, Oertel WH, Stiasny-Kolster K, Geisler P, Beneš H, García-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. — View Citation

Oertel W, Trenkwalder C, Beneš H, Ferini-Strambi L, Högl B, Poewe W, Stiasny-Kolster K, Fichtner A, Schollmayer E, Kohnen R, García-Borreguero D; SP710 study group. Long-term safety and efficacy of rotigotine transdermal patch for moderate-to-severe idiop — View Citation

Oertel WH, Benes H, Garcia-Borreguero D, Geisler P, Högl 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 s — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	Up to five years	No

External Links

•   FDA Safety Alerts and Recalls