Named Patient Program With Rotigotine Transdermal System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT01095484
First received: March 26, 2010
Last updated: October 17, 2014
Last verified: December 2012
  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) ] [ 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:

    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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01095484     History of Changes
Other Study ID Numbers: SP0953
Study First Received: March 26, 2010
Last Updated: October 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by UCB Pharma:
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 October 19, 2014