Sarizotan in Parkinson Patients With L-dopa-induced Dyskinesia

This study has been completed.
Sponsor:
Information provided by:
EMD Serono
ClinicalTrials.gov Identifier:
NCT00314288
First received: April 12, 2006
Last updated: October 22, 2013
Last verified: October 2013
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00314288

  Hide Study Locations
Locations
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: October 22, 2013
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:
Parkinson Disease
Dyskinesias
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014