Sarizotan in Parkinson Patients With L-Dopa-Induced Dyskinesia
This study has been completed.
Sponsor:
EMD Serono
Information provided by:
EMD Serono
ClinicalTrials.gov Identifier:
NCT00314288
First received: April 12, 2006
Last updated: March 21, 2009
Last verified: March 2009
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Purpose
The primary purpose of the study is to investigate the anti-dyskinetic effect of several doses of sarizotan in Parkinson patients in order to generate information on the dose-response relationship (dose-finding).
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson's Disease Dyskinesia |
Drug: Sarizotan HCl |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Multicenter, Multinational, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Finding Study to Investigate the Anti-Dyskinetic Efficacy and Safety of Sarizotan in Parkinson Patients With L-Dopa-Induced Dyskinesia |
Resource links provided by NLM:
MedlinePlus related topics:
Parkinson's Disease
Drug Information available for:
Levodopa
U.S. FDA Resources
Further study details as provided by EMD Serono:
Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or Female
- The subject is an out-patient
- Age 30 years or above
- Dyskinesias present during more than 25% of the waking day
- Dyskinesias at least moderately disabling
- Written informed consent
Exclusion Criteria:
- Pregnancy and/or lactation
- Participation in another study within the last 30 days
- Dementia or other psychiatric illness that prevents provision of informed consent
- History of allergic disorders such as asthma
- Known hypersensitivity to the study treatment(s)
- Known hypersensitivity to ACTH
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00314288
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Hide Study LocationsLocations
| United States, California | |
| Fountain Valley, California, United States | |
| Sunnyvale, California, United States | |
| United States, Florida | |
| Miami, Florida, United States | |
| Tampa, Florida, United States | |
| United States, Georgia | |
| Atlanta, Georgia, United States | |
| United States, Illinois | |
| Chicago, Illinois, United States | |
| United States, Maine | |
| Augusta, Maine, United States | |
| United States, Massachusetts | |
| Boston, Massachusetts, United States | |
| United States, Missouri | |
| Kansas City, Missouri, United States | |
| United States, New York | |
| Brooklyn, New York, United States | |
| New York, New York, United States | |
| United States, Ohio | |
| Cincinatti, Ohio, United States | |
| Columbus, Ohio, United States | |
| United States, Pennsylvania | |
| Philadelphia, Pennsylvania, United States | |
| United States, Rhode Island | |
| Pawtucket, Rhode Island, United States | |
| United States, Tennessee | |
| Memphis, Tennessee, United States | |
| United States, Texas | |
| Houston, Texas, United States | |
| Belgium | |
| Leuven, Belgium | |
| Bulgaria | |
| Sofia, Bulgaria | |
| Canada | |
| Edmonton, Canada | |
| Saskatoon, Canada | |
| Vancouver, Canada | |
| France | |
| Clermont-Ferrand, France | |
| Marseille, France | |
| Nantes, France | |
| Paris, France | |
| Toulouse, France | |
| Germany | |
| Bochum, Germany | |
| Dresden, Germany | |
| Leipzig, Germany | |
| Lübeck, Germany | |
| München, Germany | |
| Ulm, Germany | |
| Wiesbaden, Germany | |
| Hungary | |
| Budapest, Hungary | |
| Gyor, Hungary | |
| Miskolc, Hungary | |
| Portugal | |
| Coimbra, Portugal | |
| Lisbon, Portugal | |
| Romania | |
| Bucaresti, Romania | |
| Constanta, Romania | |
| Targu-Mures, Romania | |
| South Africa | |
| George, South Africa | |
| Plumstead Cape Town, South Africa | |
| Rosebank, South Africa | |
| Sunninghill, South Africa | |
| Wilgers, South Africa | |
| United Kingdom | |
| Cambridge, United Kingdom | |
| Newcastle, United Kingdom | |
| Nottingham, United Kingdom | |
| Sheffield, United Kingdom | |
Sponsors and Collaborators
EMD Serono
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00314288 History of Changes |
| Other Study ID Numbers: | EMR 62225-006 |
| Study First Received: | April 12, 2006 |
| Last Updated: | March 21, 2009 |
| Health Authority: | United States: Food and Drug Administration Germany: Federal Institute for Drugs and Medical Devices Belgium: Directoraat Generaal Geneesmiddelen Bulgaria: Bulgarian Drug Agency Canada: Health Canada France: Agence Française de Sécurité Sanitaire des Produits de Santé Portugal: Instituto Nacional da Farmácia e do Medicamento Romania: National Medicines Agency South Africa: Medicines Control Council United Kingdom: Medicines and Healthcare Products Regulatory Agency Hungary: National Institute of Pharmacy |
Keywords provided by EMD Serono:
|
Parkinson's Disease Dyskinesia L-dopa-induced dyskinesia |
Additional relevant MeSH terms:
|
Dyskinesias Parkinson Disease Movement Disorders Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Neurodegenerative Diseases |
Levodopa Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013