Conditions for Which There is a Documented Medical Necessity to Receive Treatment With Rotigotine
Conditions
Keywords
Rotigotine, Neupro®
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.
Interventions
DRUGRotigotine patch
1 patch daily for up to 48 months. Patch strength (per 24 hours): 1 mg - 8 mg based on investigator's assessment
Sponsors
UCB Pharma
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Adverse events as reported spontaneously by the subject or as assessed by the investigator at the maintenance visits (about every three months) |
Countries
United States
Outcome results
None listed