Sarizotan HC1 in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia
NCT ID: NCT00105508
Last Updated: 2018-07-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
506 participants
INTERVENTIONAL
2004-09-30
2006-02-28
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
NONE
Study Groups
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Sarizotan
Sarizotan
Subjects will receive sarizotan 1 milligram orally twice daily for 24 weeks.
Placebo
Placebo
Subjects will receive placebo matched to sarizotan orally twice daily for 24 weeks.
Interventions
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Sarizotan
Subjects will receive sarizotan 1 milligram orally twice daily for 24 weeks.
Placebo
Subjects will receive placebo matched to sarizotan orally twice daily for 24 weeks.
Eligibility Criteria
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Inclusion Criteria
* The subject presents with a diagnosis of idiopathic Parkinson's disease.
* Prior therapy with all registered Parkinsonian medication is allowed.
Exclusion Criteria
* The subject is participating in another clinical study or has done so within the past 30 days.
* The subject has received neurosurgical intervention related to PD.
* The subject has relevant renal impairment.
* The subject has relevant hepatic impairment.
* The subject is suffering from any dementia or psychiatric illness.
* The subject has a history of allergic asthma.
30 Years
ALL
No
Sponsors
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EMD Serono
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany
Locations
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Birmingham, Alabama, United States
Huntsville, Alabama, United States
La Jolla, California, United States
Oxnard, California, United States
Sacramento, California, United States
Englewood, Colorado, United States
Danbury, Connecticut, United States
Farmington, Connecticut, United States
Jacksonville, Florida, United States
Jacksonville, Florida, United States
Maitland, Florida, United States
St. Petersburg, Florida, United States
Decatur, Georgia, United States
Chicago, Illinois, United States
Springfield, Illinois, United States
Des Moines, Iowa, United States
New Orleans, Louisiana, United States
Scarborough, Maine, United States
Boston, Massachusetts, United States
Southfield, Michigan, United States
Edison, New Jersey, United States
New Hyde Park, New York, United States
New Hyde Park, New York, United States
New York, New York, United States
Durham, North Carolina, United States
Oklahoma City, Oklahoma, United States
Pittsburgh, Pennsylvania, United States
Brentwood, Tennessee, United States
South Ogden, Utah, United States
Spokane, Washington, United States
Milwaukee, Wisconsin, United States
Countries
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References
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Goetz CG, Laska E, Hicking C, Damier P, Muller T, Nutt J, Warren Olanow C, Rascol O, Russ H. Placebo influences on dyskinesia in Parkinson's disease. Mov Disord. 2008 Apr 15;23(5):700-7. doi: 10.1002/mds.21897.
Related Links
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EudraCT results summary synopsis
Other Identifiers
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EMR 62225-018
Identifier Type: -
Identifier Source: org_study_id
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