Trial to Assess Parkinson's Disease (PD) Symptom Control to Four Doses of Rotigotine in a Transdermal Patch
NCT ID: NCT00522379
Last Updated: 2014-10-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
514 participants
INTERVENTIONAL
2007-07-31
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Rotigotine 2 mg/24 hr
Rotigotine
2 mg/24 hr (one 10 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
Rotigotine 4 mg/24 hr
Rotigotine
4 mg/24 hr (one 20 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
Rotigotine 6 mg/24 hr
Rotigotine
6 mg/24 hr (one 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
Rotigotine 8 mg/24 hr
Rotigotine
8 mg/24 hr (two 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
Placebo
Placebo
Placebo transdermal patch applied daily
Interventions
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Rotigotine
2 mg/24 hr (one 10 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
Rotigotine
4 mg/24 hr (one 20 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
Placebo
Placebo transdermal patch applied daily
Rotigotine
6 mg/24 hr (one 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
Rotigotine
8 mg/24 hr (two 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stable dose L-dopa but symptoms not adequately controlled and have "off" time
* Able and willing to complete diary on specific days
Exclusion Criteria
* 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
* Pregnant or of child-bearing potential
* Impulse control disorder
30 Years
ALL
No
Sponsors
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UCB Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493 (UCB)
Locations
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Birmingham, Alabama, United States
Tuscaloosa, Alabama, United States
Gilbert, Arizona, United States
Peoria, Arizona, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Little Rock, Arkansas, United States
Fountain Valley, California, United States
Fresno, California, United States
Irvine, California, United States
La Jolla, California, United States
Loma Linda, California, United States
Oxnard, California, United States
Aurora, Colorado, United States
New Haven, Connecticut, United States
Boca Raton, Florida, United States
Bradenton, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Naples, Florida, United States
Ocala, Florida, United States
Ormond Beach, Florida, United States
Pompano Beach, Florida, United States
St. Petersburg, Florida, United States
Sunrise, Florida, United States
Atlanta, Georgia, United States
Decatur, Georgia, United States
Macon, Georgia, United States
Suwanee, Georgia, United States
Chicago, Illinois, United States
Anderson, Indiana, United States
Des Moines, Iowa, United States
Kansas City, Kansas, United States
Louisville, Kentucky, United States
Southfield, Michigan, United States
Golden Valley, Minnesota, United States
St Louis, Missouri, United States
Missoula, Montana, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Commack, New York, United States
New York, New York, United States
Rochester, New York, United States
Raleigh, North Carolina, United States
Salisbury, North Carolina, United States
Columbus, Ohio, United States
Toledo, Ohio, United States
Greensburg, Pennsylvania, United States
Souderton, Pennsylvania, United States
Upland, Pennsylvania, United States
Memphis, Tennessee, United States
Lubbock, Texas, United States
San Antonio, Texas, United States
Midvale, Utah, United States
South Ogden, Utah, United States
Alexandria, Virginia, United States
Richmond, Virginia, United States
Roanoke, Virginia, United States
Virginia Beach, Virginia, United States
Kirkland, Washington, United States
Spokane, Washington, United States
Milwaukee, Wisconsin, United States
Santiago, Chile, Chile
Hyderbad, Andhra Pradesh, India
Bangalore, Kamataka, India
Mangalore, Kamataka, India
Mysore, Karnataka, India
Calicut, Kerala, India
Thiruvananthapuram, Kerala, India
Indore, Madhya Pradesh, India
Mumbai, Maharashtra, India
Pune, Maharashtra, India
Chennai, Tamil Nadu, India
Aguascalientes, Aguascalientes, Mexico
Monterrey, Nuevo León, Mexico
San Isidro, Lima region, Peru
Santiago de Surco, Lima region, Peru
Countries
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References
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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.
Other Identifiers
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SP0921
Identifier Type: -
Identifier Source: org_study_id
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