Sarizotan in Parkinson Patients With L-Dopa-Induced Dyskinesia - Full Text View

Sponsor:	EMD Serono
Information provided by:	EMD Serono
ClinicalTrials.gov Identifier:	NCT00314288

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 II

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:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease Perry syndrome

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Levodopa Sarizotan Sarizotan hydrochloride

U.S. FDA Resources

Further study details as provided by EMD Serono:

Estimated Enrollment:	360
Study Start Date:	July 2002
Estimated Study Completion Date:	July 2003

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

Show 51 Study Locations

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 February 09, 2012