Named Patient Program With Rotigotine Transdermal System
NCT ID: NCT01095484
Last Updated: 2014-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
520 participants
OBSERVATIONAL
2008-11-30
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Rotigotine
Patients who have a documented medical necessity to receive treatment with rotigotine treatment in accordance with standard medical practice.
Rotigotine patch
1 patch daily for up to 48 months. Patch strength (per 24 hours): 1 mg - 8 mg based on investigator's assessment
Interventions
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Rotigotine patch
1 patch daily for up to 48 months. Patch strength (per 24 hours): 1 mg - 8 mg based on investigator's assessment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject is willing and able to comply with all trial requirements
* Subject either:
1. is currently taking no more than 3 mg/24 h Rotigotine for Idiopathic Restless Legs Syndrome (RLS) in adults, 6 mg/24 h Rotigotine for early-stage Parkinson's disease, 8 mg/24 h Rotigotine for advanced stage Parkinson's disease (ie, treated with concomitant l-dopa) and has tried and failed an adequate course of another dopamine agonist, with failure defined as either suboptimal control of symptoms or the development of intolerable Adverse Events (AEs) (eg, hallucinations), or
2. is not taking Rotigotine but has previously demonstrated an adequate response following an appropriate course of treatment with another dopamine agonist or l-dopa, based on the investigator's assessment and has tried and failed an adequate course of another dopamine agonist, or
3. has completed participation in UCB Rotigotine clinical trial SP0934, SP1055, or RL0003
* The investigator attests to the medical necessity of treatment with Rotigotine in contrast to alternate treatments (eg, dysphagia).
* The investigator receives written approval from the Sponsor to enroll the subject
Exclusion Criteria
* Subject has any other clinically significant medical condition, psychiatric condition, or laboratory abnormality that would, in the judgment of the investigator, interfere with the subject's ability to participate in the trial
* Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the Columbia Suicide Severity Rating Scale (C SSRS) at Screening
18 Years
ALL
No
Sponsors
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UCB Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493 (UCB)
Locations
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088
Birmingham, Alabama, United States
082
Cullman, Alabama, United States
085
Fairhope, Alabama, United States
014
Huntsville, Alabama, United States
097
Gilbert, Arizona, United States
003
Phoenix, Arizona, United States
044
Phoenix, Arizona, United States
036
Berkeley, California, United States
024
Fountain Valley, California, United States
034
Irvine, California, United States
019
Los Angeles, California, United States
040
Orange, California, United States
076
Sunnyvale, California, United States
035
Fort Collins, Colorado, United States
027
Washington D.C., District of Columbia, United States
070
Atlantis, Florida, United States
002
Boca Raton, Florida, United States
031
Clearwater, Florida, United States
028
Largo, Florida, United States
075
Ormond Beach, Florida, United States
022
St. Petersburg, Florida, United States
004
Tampa, Florida, United States
054
Weston, Florida, United States
030
Atlanta, Georgia, United States
041
Honolulu, Hawaii, United States
011
Peoria, Illinois, United States
025
Destrehan, Louisiana, United States
091
Clinton Township, Michigan, United States
001
Southfield, Michigan, United States
042
Warren, Michigan, United States
037
Ocean Springs, Mississippi, United States
016
West Plains, Missouri, United States
026
Lincoln, Nebraska, United States
086
Freehold, New Jersey, United States
062
Ridgewood, New Jersey, United States
018
Albany, New York, United States
066
Brooklyn, New York, United States
006
Patchogue, New York, United States
052
Charlotte, North Carolina, United States
093
Salisbury, North Carolina, United States
065
Albany, Oregon, United States
009
Salem, Oregon, United States
048
Austin, Texas, United States
072
Austin, Texas, United States
071
Dallas, Texas, United States
046
Houston, Texas, United States
005
Kirkland, Washington, United States
017
Olympia, Washington, United States
012
Spokane, Washington, United States
053
Tacoma, Washington, United States
056
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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SP0953
Identifier Type: -
Identifier Source: org_study_id
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