Trial to Assess Parkinson's Disease (PD) Symptom Control to Four Doses of Rotigotine in a Transdermal Patch
A Multicenter, Randomized, Double-blind, Placebo-controlled, 5-arm, Parallel-group Trial to Assess Rotigotine Transdermal System Dose Response in Subjects With Advanced-stage Parkinson's Disease
1 other identifier
interventional
514
5 countries
77
Brief Summary
The purpose of this study is to show Rotigotine dose response at four doses of Rotigotine used with L-dopa in treating advanced stage Parkinson's disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2007
Typical duration for phase_3
77 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 28, 2007
CompletedFirst Posted
Study publicly available on registry
August 29, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedResults Posted
Study results publicly available
December 10, 2012
CompletedOctober 27, 2014
December 1, 2012
4 years
August 28, 2007
July 3, 2012
October 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Change in the Absolute Time Spent "Off" From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary
Time "Off" is defined as when the patient does not have the effect of anti-Parkinson's medication.
From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].
Secondary Outcomes (18)
The Change in Relative Time Spent "Off" From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary
From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].
The Change in the Absolute Time Spent "on" From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary
From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].
The Change in the Relative Time Spent "on" From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary
From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].
The Change in the Status of the Subject After Wake-Up From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary
From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II From Baseline to the End of the Maintenance Period
From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].
- +13 more secondary outcomes
Study Arms (5)
Rotigotine 2 mg/24 hr
EXPERIMENTALRotigotine 4 mg/24 hr
EXPERIMENTALRotigotine 6 mg/24 hr
EXPERIMENTALRotigotine 8 mg/24 hr
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
2 mg/24 hr (one 10 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
Eligibility Criteria
You may qualify if:
- PD greater than 3 years
- Stable dose L-dopa but symptoms not adequately controlled and have "off" time
- Able and willing to complete diary on specific days
You may not qualify if:
- Previous use of rotigotine or Neupro
- Atypical Parkinson's syndrome
- Pallidotomy
- Thalamotomy
- Deep brain stimulation
- Fetal tissue transplant
- Dementia
- Psychosis
- Hallucinations
- Epilepsy
- Renal or hepatic dysfunction
- Clinically relevant cardiac dysfunction
- Symptomatic orthostatic hypotension
- Skin sensitivity to adhesives or unresolved contact dermatitis
- History of chronic alcohol or drug abuse
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (77)
Unknown Facility
Birmingham, Alabama, United States
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Tuscaloosa, Alabama, United States
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Gilbert, Arizona, United States
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Peoria, Arizona, United States
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Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Little Rock, Arkansas, United States
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Fountain Valley, California, United States
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Fresno, California, United States
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Irvine, California, United States
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La Jolla, California, United States
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Loma Linda, California, United States
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Oxnard, California, United States
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Aurora, Colorado, United States
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New Haven, Connecticut, United States
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Boca Raton, Florida, United States
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Bradenton, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Naples, Florida, United States
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Ocala, Florida, United States
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Ormond Beach, Florida, United States
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Pompano Beach, Florida, United States
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St. Petersburg, Florida, United States
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Sunrise, Florida, United States
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Atlanta, Georgia, United States
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Decatur, Georgia, United States
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Macon, Georgia, United States
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Suwanee, Georgia, United States
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Chicago, Illinois, United States
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Anderson, Indiana, United States
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Des Moines, Iowa, United States
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Kansas City, Kansas, United States
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Louisville, Kentucky, United States
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Southfield, Michigan, United States
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Golden Valley, Minnesota, United States
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St Louis, Missouri, United States
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Missoula, Montana, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Commack, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Raleigh, North Carolina, United States
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Salisbury, North Carolina, United States
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Columbus, Ohio, United States
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Toledo, Ohio, United States
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Greensburg, Pennsylvania, United States
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Souderton, Pennsylvania, United States
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Upland, Pennsylvania, United States
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Memphis, Tennessee, United States
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Lubbock, Texas, United States
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San Antonio, Texas, United States
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Midvale, Utah, United States
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South Ogden, Utah, United States
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Alexandria, Virginia, United States
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Richmond, Virginia, United States
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Roanoke, Virginia, United States
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Virginia Beach, Virginia, United States
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Kirkland, Washington, United States
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Spokane, Washington, United States
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Milwaukee, Wisconsin, United States
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Santiago, Chile, Chile
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Hyderbad, Andhra Pradesh, India
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Bangalore, Kamataka, India
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Mangalore, Kamataka, India
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Mysore, Karnataka, India
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Calicut, Kerala, India
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Thiruvananthapuram, Kerala, India
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Indore, Madhya Pradesh, India
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Mumbai, Maharashtra, India
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Pune, Maharashtra, India
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Chennai, Tamil Nadu, India
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Aguascalientes, Aguascalientes, Mexico
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Monterrey, Nuevo León, Mexico
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San Isidro, Lima region, Peru
Unknown Facility
Santiago de Surco, Lima region, Peru
Related Publications (1)
LeWitt PA, Poewe W, Elmer LW, Asgharnejad M, Boroojerdi B, Grieger F, Bauer L. The Efficacy Profile of Rotigotine During the Waking Hours in Patients With Advanced Parkinson's Disease: A Post Hoc Analysis. Clin Neuropharmacol. 2016 Mar-Apr;39(2):88-93. doi: 10.1097/WNF.0000000000000133.
PMID: 26882318DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB (Study Director)
- Organization
- UCB Clinical Trial Call Center
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2007
First Posted
August 29, 2007
Study Start
July 1, 2007
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
October 27, 2014
Results First Posted
December 10, 2012
Record last verified: 2012-12