Back to resultsPhase 3 Open-label Extension Trial With Rotigotine in Idiopathic Restless Legs Syndrome Subjects
Primary Purpose
Idiopathic Restless Legs Syndrome
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Rotigotine
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Restless Legs Syndrome focused on measuring Rotigotine, Restless Legs Syndrome
Eligibility Criteria
Inclusion Criteria:
- Subject completed the Maintenance Period and Taper Period of SP790 or SP794
Exclusion Criteria:
- Subject has an ongoing serious adverse event (SAE) from SP790 or SP794 that is assessed to be related to the trial medication by the investigator and/or the sponsor.
- Subject has any medical or psychiatric condition that, in the opinion of the investigator, can jeopardize or would compromise the subject's ability to participate in this trial
Sites / Locations
Outcomes
Primary Outcome Measures
Adverse events, changes in laboratory tests, vital signs, physical and neurological examination, menstrual and sexual function, 12-lead ECGs. Subject's rating of daytime sleepiness, global subject rating of tolerability
Secondary Outcome Measures
Change in the International Restless Legs Scale (IRLS) sum score, in CGI Items 1 and 2-3, in RLS-6 Rating Scales. IRLS Responder
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00498108
Brief Title
Phase 3 Open-label Extension Trial With Rotigotine in Idiopathic Restless Legs Syndrome Subjects
Official Title
An Open-label Extension Trial to Investigate the Safety and Tolerability of Long-term Treatment With Transdermal Rotigotine in Subjects With Idiopathic Restless Legs Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
UCB Pharma
4. Oversight
5. Study Description
Brief Summary
This is a multicenter, open-label trial to assess safety and tolerability of rotigotine in subjects with idiopathic Restless Legs Syndrome (RLS), administered at an optimal dose for up to 1 year in subjects who previously participated in SP790 (6-month pivotal trial) or SP794 (sleep lab trial). Subjects who successfully completed the Maintenance Period and the Taper Period of SP790 or SP794 are allowed to enroll in this trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Restless Legs Syndrome
Keywords
Rotigotine, Restless Legs Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
341 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Rotigotine
Primary Outcome Measure Information:
Title
Adverse events, changes in laboratory tests, vital signs, physical and neurological examination, menstrual and sexual function, 12-lead ECGs. Subject's rating of daytime sleepiness, global subject rating of tolerability
Secondary Outcome Measure Information:
Title
Change in the International Restless Legs Scale (IRLS) sum score, in CGI Items 1 and 2-3, in RLS-6 Rating Scales. IRLS Responder
Time Frame
from Baseline at the end of the Maintenance Period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject completed the Maintenance Period and Taper Period of SP790 or SP794
Exclusion Criteria:
Subject has an ongoing serious adverse event (SAE) from SP790 or SP794 that is assessed to be related to the trial medication by the investigator and/or the sponsor.
Subject has any medical or psychiatric condition that, in the opinion of the investigator, can jeopardize or would compromise the subject's ability to participate in this trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
UCB Pharma
Official's Role
Study Director
Facility Information:
City
Kassel
ZIP/Postal Code
34128
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Phase 3 Open-label Extension Trial With Rotigotine in Idiopathic Restless Legs Syndrome Subjects
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