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

April 12, 2006
October 22, 2013
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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom,   Belgium,   Bulgaria,   Canada,   France,   Germany,   Hungary,   Portugal,   Romania,   South Africa
 
NCT00314288
EMR 62225-006
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EMD Serono
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Not Provided
EMD Serono
October 2013

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