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Completed

NCT Number: NCT01095484

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

088, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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
  • 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
  • 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

Treatment and study plan

Rotigotine patch

Drug

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

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Mar 30, 2010
Registry last updated
Oct 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.