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

September 24, 2014 updated by: UCB Pharma

An Open-label Extension Trial to Determine Safety and Tolerability of Long-term Transdermal Application of Rotigotine in Subjects With Idiopathic Restless Legs Syndrome

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

295

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study 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
      • Barcelona, Spain
      • Madrid, Spain
    • Valencia
      • Alcira, Valencia, Spain

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Neupro®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

July 6, 2007

First Submitted That Met QC Criteria

July 6, 2007

First Posted (Estimate)

July 9, 2007

Study Record Updates

Last Update Posted (Estimate)

October 2, 2014

Last Update Submitted That Met QC Criteria

September 24, 2014

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP0710

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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