Trial to Evaluate The Efficacy Of Rotigotine on Parkinson's Disease-Associated Motor Symptoms And Apathy
NCT ID: NCT01782222
Last Updated: 2018-08-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
122 participants
INTERVENTIONAL
2013-02-28
2014-03-31
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
QUADRUPLE
Study Groups
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Rotigotine, high dose
Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease
Rotigotine
Rotigotine, transdermal patches:
10 cm\^2 (2 mg / 24 hours); 20 cm\^2 (4 mg / 24 hours); 30 cm\^2 (6 mg / 24 hours); 40 cm\^2 (8 mg / 24 hours)
The maximum Rotigotine dose allowed is 8 mg / 24 hours or 16 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours or 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)
Rotigotine, low dose
Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease
Rotigotine
Rotigotine, transdermal patches:
10 cm\^2 (2 mg / 24 hours); 20 cm\^2 (4 mg / 24 hours); 30 cm\^2 (6 mg / 24 hours); 40 cm\^2 (8 mg / 24 hours)
The maximum Rotigotine dose allowed is 8 mg / 24 hours or 16 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours or 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)
Placebo
Placebo transdermal patches
Placebo
Placebo, matching transdermal patches
Duration: up to 21 weeks (including de-escalation)
Interventions
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Rotigotine
Rotigotine, transdermal patches:
10 cm\^2 (2 mg / 24 hours); 20 cm\^2 (4 mg / 24 hours); 30 cm\^2 (6 mg / 24 hours); 40 cm\^2 (8 mg / 24 hours)
The maximum Rotigotine dose allowed is 8 mg / 24 hours or 16 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours or 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)
Placebo
Placebo, matching transdermal patches
Duration: up to 21 weeks (including de-escalation)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with advanced idiopathic Parkinson's Disease: intake of Levodopa on a stable dose of at least 200 mg/day
* Unsatisfactory control of Parkinson's Disease motor symptoms under current treatment
* Patients experiencing Apathy associated with Parkinson's Disease
* Hoehn and Yahr stage score of I to IV
* Mini-Mental State Examination score ≥ 25
* If an antidepressant drug is taken, the dose must be stable
Exclusion Criteria
* Discontinuation from pervious therapy with a dopamine agonist after an adequate length of treatment, at adequate dose, due to lack of efficacy
* Any medical or psychiatric condition that jeopardizes / compromises patient's ability for participation
* Patient has received Neuroleptics, Dopamine releasing substances, Dopamine modulating substances, Alpha-Methyldopa, Metoclopramide, MAO-A inhibitors, Budipine, or Tolcapone
* Electroconvulsive therapy
* Patient has a
* current/anticipated psychotherapy or behavior therapy
* history of deep brain stimulation
* history of suicide attempt or has suicidal ideation
* impulse control disorder
* severe Depression
18 Years
ALL
No
Sponsors
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UCB BIOSCIENCES GmbH
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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4320
Birmingham, Alabama, United States
4309
Oxnard, California, United States
4306
Ormond Beach, Florida, United States
4311
Palm Beach Gardens, Florida, United States
4313
Tampa, Florida, United States
4314
Decatur, Georgia, United States
4318
Chicago, Illinois, United States
4316
Winfield, Illinois, United States
4322
Des Moines, Iowa, United States
4304
Kansas City, Kansas, United States
4326
Springfield, Massachusetts, United States
4330
Ocean Springs, Mississippi, United States
4302
Las Vegas, Nevada, United States
4303
Commack, New York, United States
4317
New York, New York, United States
4323
New York, New York, United States
4319
Asheville, North Carolina, United States
4325
Charlotte, North Carolina, United States
4329
Akron, Ohio, United States
4312
Cincinnati, Ohio, United States
4324
Beaufort, South Carolina, United States
4332
Charleston, South Carolina, United States
4305
San Antonio, Texas, United States
4307
Salt Lake City, Utah, United States
4333
Virginia Beach, Virginia, United States
3001
Innsbruck, , Austria
3003
Linz, , Austria
3301
Budapest, , Hungary
3302
Debrecen, , Hungary
3509
Gdansk, , Poland
3506
Gdynia, , Poland
3504
Poznan, , Poland
3801
Banská Bystrica, , Slovakia
3805
Bratislava, , Slovakia
3806
Krompachy, , Slovakia
3807
Žilina, , Slovakia
3901
Ljubljana, , Slovenia
4001
Barcelona, , Spain
4006
Barcelona, , Spain
4009
Oviedo, , Spain
4005
Seville, , Spain
4010
Seville, , Spain
Countries
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References
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Hauser RA, Slawek J, Barone P, Dohin E, Surmann E, Asgharnejad M, Bauer L. Evaluation of rotigotine transdermal patch for the treatment of apathy and motor symptoms in Parkinson's disease. BMC Neurol. 2016 Jun 7;16:90. doi: 10.1186/s12883-016-0610-7.
Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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2012-002840-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PD0005
Identifier Type: -
Identifier Source: org_study_id
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