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

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

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)

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

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