Named Patient Program With Rotigotine Transdermal System

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.

Study Overview

• Status: Completed
• Conditions: Conditions for Which There is a Documented Medical Necessity to Receive Treatment With Rotigotine
• Intervention / Treatment: Drug: Rotigotine patch

• Study Type: Observational
• Enrollment (Actual): 520

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States
      • 088
    • Cullman, Alabama, United States
      • 082
    • Fairhope, Alabama, United States
      • 085
    • Huntsville, Alabama, United States
      • 014
  • Arizona
    • Gilbert, Arizona, United States
      • 097
    • Phoenix, Arizona, United States
      • 003
    • Phoenix, Arizona, United States
      • 044
  • California
    • Berkeley, California, United States
      • 036
    • Fountain Valley, California, United States
      • 024
    • Irvine, California, United States
      • 034
    • Los Angeles, California, United States
      • 019
    • Orange, California, United States
      • 040
    • Sunnyvale, California, United States
      • 076
  • Colorado
    • Fort Collins, Colorado, United States
      • 035
  • District of Columbia
    • Washington, District of Columbia, United States
      • 027
  • Florida
    • Atlantis, Florida, United States
      • 070
    • Boca Raton, Florida, United States
      • 002
    • Clearwater, Florida, United States
      • 031
    • Largo, Florida, United States
      • 028
    • Ormond Beach, Florida, United States
      • 075
    • St. Petersburg, Florida, United States
      • 022
    • Tampa, Florida, United States
      • 004
    • Weston, Florida, United States
      • 054
  • Georgia
    • Atlanta, Georgia, United States
      • 030
  • Hawaii
    • Honolulu, Hawaii, United States
      • 041
  • Illinois
    • Peoria, Illinois, United States
      • 011
  • Louisiana
    • Destrehan, Louisiana, United States
      • 025
  • Michigan
    • Clinton Township, Michigan, United States
      • 091
    • Southfield, Michigan, United States
      • 001
    • Warren, Michigan, United States
      • 042
  • Mississippi
    • Ocean Springs, Mississippi, United States
      • 037
  • Missouri
    • West Plains, Missouri, United States
      • 016
  • Nebraska
    • Lincoln, Nebraska, United States
      • 026
  • New Jersey
    • Freehold, New Jersey, United States
      • 086
    • Ridgewood, New Jersey, United States
      • 062
  • New York
    • Albany, New York, United States
      • 018
    • Brooklyn, New York, United States
      • 066
    • Patchogue, New York, United States
      • 006
  • North Carolina
    • Charlotte, North Carolina, United States
      • 052
    • Salisbury, North Carolina, United States
      • 093
  • Oregon
    • Albany, Oregon, United States
      • 065
    • Salem, Oregon, United States
      • 009
  • Texas
    • Austin, Texas, United States
      • 048
    • Austin, Texas, United States
      • 072
    • Dallas, Texas, United States
      • 071
    • Houston, Texas, United States
      • 046
  • Washington
    • Kirkland, Washington, United States
      • 005
    • Olympia, Washington, United States
      • 017
    • Spokane, Washington, United States
      • 012
    • Tacoma, Washington, United States
      • 053
  • Wisconsin
    • Milwaukee, Wisconsin, United States
      • 056

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 Names: Neupro patch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events as reported spontaneously by the subject or as assessed by the investigator at the maintenance visits (about every three months)	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)

Collaborators and Investigators

• Sponsor: UCB Pharma

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (ACTUAL): December 1, 2012
• Study Completion (ACTUAL): December 1, 2012

Study Registration Dates

• First Submitted: March 26, 2010
• First Submitted That Met QC Criteria: March 29, 2010
• First Posted (ESTIMATE): March 30, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): October 20, 2014
• Last Update Submitted That Met QC Criteria: October 17, 2014
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Rotigotine; Neupro®
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Dopamine Agonists; Dopamine Agents; Rotigotine
• Other Study ID Numbers: SP0953