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Named Patient Program With Rotigotine Transdermal System

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.
 
ClinicalTrials.gov Identifier: NCT01095484
Recruitment Status : Completed
First Posted : March 30, 2010
Last Update Posted : October 20, 2014
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Tracking Information
First Submitted Date March 26, 2010
First Posted Date March 30, 2010
Last Update Posted Date October 20, 2014
Study Start Date November 2008
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 21, 2012)
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)
Original Primary Outcome Measures
 (submitted: March 29, 2010)
Adverse Events [ Time Frame: From Baseline to End of Study (up to 34 months) ]
Adverse events as reported spontaneously by the subject or as assessed by the investigator at the maintenance visits (about every three months).
Change History Complete list of historical versions of study NCT01095484 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Named Patient Program With Rotigotine Transdermal System
Official Title Named Patient Program With Rotigotine Transdermal System
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 Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Conditions for Which There is a Documented Medical Necessity to Receive Treatment With Rotigotine
Intervention 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
Study Groups/Cohorts Rotigotine
Patients who have a documented medical necessity to receive treatment with rotigotine treatment in accordance with standard medical practice.
Intervention: Drug: Rotigotine patch
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 18, 2012)
520
Original Estimated Enrollment
 (submitted: March 29, 2010)
250
Actual Study Completion Date December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01095484
Other Study ID Numbers SP0953
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party UCB Pharma
Study Sponsor UCB Pharma
Collaborators Not Provided
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
PRS Account UCB Pharma
Verification Date December 2012