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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00498186
First received: July 6, 2007
Last updated: October 14, 2011
Last verified: October 2011
  Purpose

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).


Condition Intervention Phase
Restless Legs Syndrome
Drug: Rotigotine
Phase 2

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

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

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. [ Time Frame: Up to five years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to five years ] [ Designated as safety issue: No ]
    Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.


Enrollment: 295
Study Start Date: July 2003
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rotigotine
Rotigotine trans-dermal patch
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)

Other Name: Neupro®

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00498186

Locations
Austria
Innsbruck, Austria
Germany
Bamberg, Germany
Berlin, Germany
Bielefeld, Germany
Gelsenkirchen, Germany
Gera, Germany
Halle, Germany
Jena, Germany
Kassel, Germany
Köthen, Germany
Marburg, Germany, 35039
Mittweida, Germany
München, Germany
Neubrandenburg, Germany
Oldenburg, Germany
Regensburg, Germany
Schwalmstadt-Treysa, Germany
Schwerin, Germany
Tuttlingen, Germany
Ulm, Germany
Unterhaching, Germany
Spain
Alcira, Valencia, Spain
Barcelona, Spain
Madrid, Spain
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00498186     History of Changes
Other Study ID Numbers: SP710
Study First Received: July 6, 2007
Results First Received: March 23, 2010
Last Updated: October 14, 2011
Health Authority: Austria: Agency for Health and Food Safety
Germany: Federal Institute for Drugs and Medical Devices
Spain: Spanish Agency of Medicines

Keywords provided by UCB, Inc.:
Rotigotine
Neupro®

Additional relevant MeSH terms:
Restless Legs Syndrome
Psychomotor Agitation
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Parasomnias
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
N 0437
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014