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Named Patient Program With Rotigotine Transdermal System

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01095484
First Posted: March 30, 2010
Last Update Posted: October 20, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
UCB Pharma
  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 Pharma:

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) ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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:

    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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01095484


  Show 51 Study Locations
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01095484     History of Changes
Other Study ID Numbers: SP0953
First Submitted: March 26, 2010
First Posted: March 30, 2010
Last Update Posted: October 20, 2014
Last Verified: December 2012

Keywords provided by UCB Pharma:
Rotigotine
Neupro®

Additional relevant MeSH terms:
Rotigotine
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs