Named Patient Program With Rotigotine Transdermal System

Completed

• Conditions: Conditions for Which There is a Documented Medical Necessity to Receive Treatment With Rotigotine
• Interventions: Drug: Rotigotine patch

• Registration Number: NCT01095484
• Lead Sponsor: UCB Pharma

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2010-03-26
• Study First Submitted QC: 2010-03-29
• Study First Posted: 2010-03-30
• Status Verified: 2012-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2014-10-17
• Last Update Posted: 2014-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 520

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:

  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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rotigotine	Rotigotine patch	Patients who have a documented medical necessity to receive treatment with rotigotine treatment in accordance with standard medical practice.

Primary Outcome Measures

Name	Time	Method
Adverse Events as reported spontaneously by the subject or as assessed by the investigator at the maintenance visits (about every three months)	From Baseline to End of Study (up to 48 months)	Adverse events as reported spontaneously by the subject or as assessed by the investigator at the maintenance visits (about every three months)

Trial Locations

Locations (51)

036; 🇺🇸 Berkeley, California, United States

046; 🇺🇸 Houston, Texas, United States

085; 🇺🇸 Fairhope, Alabama, United States

082; 🇺🇸 Cullman, Alabama, United States

014; 🇺🇸 Huntsville, Alabama, United States

097; 🇺🇸 Gilbert, Arizona, 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, District of Columbia, United States

002; 🇺🇸 Boca Raton, Florida, United States

070; 🇺🇸 Atlantis, Florida, United States

031; 🇺🇸 Clearwater, Florida, United States

030; 🇺🇸 Atlanta, Georgia, United States

028; 🇺🇸 Largo, Florida, United States

054; 🇺🇸 Weston, Florida, United States

075; 🇺🇸 Ormond Beach, Florida, United States

026; 🇺🇸 Lincoln, Nebraska, United States

001; 🇺🇸 Southfield, Michigan, United States

037; 🇺🇸 Ocean Springs, Mississippi, United States

016; 🇺🇸 West Plains, Missouri, United States

009; 🇺🇸 Salem, Oregon, United States

018; 🇺🇸 Albany, New York, United States

006; 🇺🇸 Patchogue, New York, United States

066; 🇺🇸 Brooklyn, New York, United States

086; 🇺🇸 Freehold, New Jersey, United States

062; 🇺🇸 Ridgewood, New Jersey, United States

005; 🇺🇸 Kirkland, Washington, United States

017; 🇺🇸 Olympia, Washington, United States

053; 🇺🇸 Tacoma, Washington, United States

012; 🇺🇸 Spokane, Washington, United States

044; 🇺🇸 Phoenix, Arizona, United States

088; 🇺🇸 Birmingham, Alabama, United States

003; 🇺🇸 Phoenix, Arizona, United States

022; 🇺🇸 St. Petersburg, Florida, United States

011; 🇺🇸 Peoria, Illinois, United States

042; 🇺🇸 Warren, Michigan, United States

025; 🇺🇸 Destrehan, Louisiana, United States

091; 🇺🇸 Clinton Township, Michigan, United States

052; 🇺🇸 Charlotte, North Carolina, United States

093; 🇺🇸 Salisbury, North Carolina, United States

065; 🇺🇸 Albany, Oregon, United States

056; 🇺🇸 Milwaukee, Wisconsin, United States

071; 🇺🇸 Dallas, Texas, United States

072; 🇺🇸 Austin, Texas, United States

004; 🇺🇸 Tampa, Florida, United States

048; 🇺🇸 Austin, Texas, United States

041; 🇺🇸 Honolulu, Hawaii, United States