Sarizotan in Parkinson Patients With L-dopa-induced Dyskinesia

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

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
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

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 identifier: NCT00314288

  Show 51 Study Locations
Sponsors and Collaborators
EMD Serono
  More Information

No publications provided 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
L-dopa-induced dyskinesia

Additional relevant MeSH terms:
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
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 processed this record on April 17, 2014