Named Patient Program With Rotigotine Transdermal System
This study has been completed.
Sponsor:
UCB, Inc.
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT01095484
First received: March 26, 2010
Last updated: December 18, 2012
Last verified: December 2012
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Purpose
The named patient program will allow investigators to supply rotigotine transdermal system to patients who have a documented medical necessity to receive treatment with the drug.
| Condition | Intervention |
|---|---|
|
Conditions for Which There is a Documented Medical Necessity to Receive Treatment With Rotigotine |
Drug: Rotigotine patch |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Named Patient Program With Rotigotine Transdermal System |
Resource links provided by NLM:
Further study details as provided by UCB, Inc.:
Primary Outcome Measures:
- Adverse Events as reported spontaneously by the subject or as assessed by the investigator at the maintenance visits (about every three months) [ Time Frame: From Baseline to End of Study (up to 48 months) ] [ Designated as safety issue: No ]Adverse events as reported spontaneously by the subject or as assessed by the investigator at the maintenance visits (about every three months)
| Enrollment: | 520 |
| Study Start Date: | November 2008 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Rotigotine
Patients who have a documented medical necessity to receive treatment with rotigotine treatment in accordance with standard medical practice.
|
Drug: 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 Name: Neupro patch
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients who have a documented medical necessity to receive treatment with rotigotine treatment in accordance with standard medical practice.
Criteria
Inclusion Criteria:
- Subject is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent
- Subject is willing and able to comply with all trial requirements
Subject either:
- 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
- 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
- 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 is pregnant or nursing or is of child bearing potential but (i) not surgically sterile or (ii) not using adequate birth control methods or (iii) not sexually abstinent or (iv) subject is not at least 2 years postmenopausal
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01095484
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Hide Study LocationsLocations
| United States, Alabama | |
| 088 | |
| Birmingham, Alabama, United States | |
| 082 | |
| Cullman, Alabama, United States | |
| 085 | |
| Fairhope, Alabama, United States | |
| 014 | |
| Huntsville, Alabama, United States | |
| United States, Arizona | |
| 097 | |
| Gilbert, Arizona, United States | |
| 003 | |
| Phoenix, Arizona, United States | |
| 044 | |
| Phoenix, Arizona, United States | |
| United States, California | |
| 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 | |
| United States, Colorado | |
| 035 | |
| Fort Collins, Colorado, United States | |
| United States, District of Columbia | |
| 027 | |
| Washington, District of Columbia, United States | |
| United States, Florida | |
| 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 | |
| United States, Georgia | |
| 030 | |
| Atlanta, Georgia, United States | |
| United States, Hawaii | |
| 041 | |
| Honolulu, Hawaii, United States | |
| United States, Illinois | |
| 011 | |
| Peoria, Illinois, United States | |
| United States, Louisiana | |
| 025 | |
| Destrehan, Louisiana, United States | |
| United States, Michigan | |
| 091 | |
| Clinton Township, Michigan, United States | |
| 001 | |
| Southfield, Michigan, United States | |
| 042 | |
| Warren, Michigan, United States | |
| United States, Mississippi | |
| 037 | |
| Ocean Springs, Mississippi, United States | |
| United States, Missouri | |
| 016 | |
| West Plains, Missouri, United States | |
| United States, Nebraska | |
| 026 | |
| Lincoln, Nebraska, United States | |
| United States, New Jersey | |
| 086 | |
| Freehold, New Jersey, United States | |
| 062 | |
| Ridgewood, New Jersey, United States | |
| United States, New York | |
| 018 | |
| Albany, New York, United States | |
| 066 | |
| Brooklyn, New York, United States | |
| 006 | |
| Patchogue, New York, United States | |
| United States, North Carolina | |
| 052 | |
| Charlotte, North Carolina, United States | |
| 093 | |
| Salisbury, North Carolina, United States | |
| United States, Oregon | |
| 065 | |
| Albany, Oregon, United States | |
| 009 | |
| Salem, Oregon, United States | |
| United States, Texas | |
| 048 | |
| Austin, Texas, United States | |
| 072 | |
| Austin, Texas, United States | |
| 071 | |
| Dallas, Texas, United States | |
| 046 | |
| Houston, Texas, United States | |
| United States, Washington | |
| 005 | |
| Kirkland, Washington, United States | |
| 017 | |
| Olympia, Washington, United States | |
| 012 | |
| Spokane, Washington, United States | |
| 053 | |
| Tacoma, Washington, United States | |
| United States, Wisconsin | |
| 056 | |
| Milwaukee, Wisconsin, United States | |
Sponsors and Collaborators
UCB, Inc.
Investigators
| Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
More Information
No publications provided
| Responsible Party: | UCB, Inc. |
| ClinicalTrials.gov Identifier: | NCT01095484 History of Changes |
| Other Study ID Numbers: | SP953 |
| Study First Received: | March 26, 2010 |
| Last Updated: | December 18, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by UCB, Inc.:
|
Rotigotine Neupro® |
Additional relevant MeSH terms:
|
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