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: January 19, 2017
Last verified: January 2017

April 12, 2006
January 19, 2017
July 2002
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Complete list of historical versions of study NCT00314288 on ClinicalTrials.gov Archive Site
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Sarizotan in Parkinson Patients With L-dopa-induced Dyskinesia
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
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).
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Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (masked roles unspecified)
Primary Purpose: Treatment
  • Parkinson's Disease
  • Dyskinesia
Drug: Sarizotan HCl
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
360
July 2003
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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
Sexes Eligible for Study: All
30 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Bulgaria,   Canada,   France,   Germany,   Hungary,   Portugal,   Romania,   South Africa,   United Kingdom
 
 
NCT00314288
EMR 62225-006
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EMD Serono
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EMD Serono
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP