Clinical trial NCT01095484: Named Patient Program With Rotigotine Transdermal System
Official title: Named Patient Program With Rotigotine Transdermal System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Conditions for Which There is a Documented Medical Necessity to Receive Treatment With Rotigotine
Keywords: Rotigotine
Neupro®
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2010-03-30
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Adverse Events as reported spontaneously by the subject or as assessed by the investigator at the maintenance visits (about every three months)
timeFrame: From Baseline to End of Study (up to 48 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 088
state: Alabama
city: Cullman
country: United States
facility: 082
state: Alabama
city: Fairhope
country: United States
facility: 085
state: Alabama
city: Huntsville
country: United States
facility: 014
state: Alabama
city: Gilbert
country: United States
facility: 097
state: Arizona
city: Phoenix
country: United States
facility: 003
state: Arizona
city: Phoenix
country: United States
facility: 044
state: Arizona
city: Berkeley
country: United States
facility: 036
state: California
city: Fountain Valley
country: United States
facility: 024
state: California
city: Irvine
country: United States
facility: 034
state: California
city: Los Angeles
country: United States
facility: 019
state: California
city: Orange
country: United States
facility: 040
state: California
city: Sunnyvale
country: United States
facility: 076
state: California
city: Fort Collins
country: United States
facility: 035
state: Colorado
city: Washington
country: United States
facility: 027
state: District of Columbia
city: Atlantis
country: United States
facility: 070
state: Florida
city: Boca Raton
country: United States
facility: 002
state: Florida
city: Clearwater
country: United States
facility: 031
state: Florida
city: Largo
country: United States
facility: 028
state: Florida
city: Ormond Beach
country: United States
facility: 075
state: Florida
city: St. Petersburg
country: United States
facility: 022
state: Florida
city: Tampa
country: United States
facility: 004
state: Florida
city: Weston
country: United States
facility: 054
state: Florida
city: Atlanta
country: United States
facility: 030
state: Georgia
city: Honolulu
country: United States
facility: 041
state: Hawaii
city: Peoria
country: United States
facility: 011
state: Illinois
city: Destrehan
country: United States
facility: 025
state: Louisiana
city: Clinton Township
country: United States
facility: 091
state: Michigan
city: Southfield
country: United States
facility: 001
state: Michigan
city: Warren
country: United States
facility: 042
state: Michigan
city: Ocean Springs
country: United States
facility: 037
state: Mississippi
city: West Plains
country: United States
facility: 016
state: Missouri
city: Lincoln
country: United States
facility: 026
state: Nebraska
city: Freehold
country: United States
facility: 086
state: New Jersey
city: Ridgewood
country: United States
facility: 062
state: New Jersey
city: Albany
country: United States
facility: 018
state: New York
city: Brooklyn
country: United States
facility: 066
state: New York
city: Patchogue
country: United States
facility: 006
state: New York
city: Charlotte
country: United States
facility: 052
state: North Carolina
city: Salisbury
country: United States
facility: 093
state: North Carolina
city: Albany
country: United States
facility: 065
state: Oregon
city: Salem
country: United States
facility: 009
state: Oregon
city: Austin
country: United States
facility: 048
state: Texas
city: Austin
country: United States
facility: 072
state: Texas
city: Dallas
country: United States
facility: 071
state: Texas
city: Houston
country: United States
facility: 046
state: Texas
city: Kirkland
country: United States
facility: 005
state: Washington
city: Olympia
country: United States
facility: 017
state: Washington
city: Spokane
country: United States
facility: 012
state: Washington
city: Tacoma
country: United States
facility: 053
state: Washington
city: Milwaukee
country: United States
facility: 056
state: Wisconsin
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: