Long-term Open-label Trial in Idiopathic Restless Legs Syndrome (RLS)
This study has been completed.
Sponsor:
UCB, Inc.
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
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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:
MedlinePlus related topics:
Restless Legs
Drug Information available for:
Rotigotine
U.S. FDA Resources
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 May 21, 2013