Sarizotan in Parkinson Patients With L-dopa-induced Dyskinesia

Phase 2

Completed

• Conditions: Parkinson's Disease; Dyskinesia

• Registration Number: NCT00314288
• Lead Sponsor: EMD Serono

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2002-07
• Study Completion: 2003-07
• Study First Submitted: 2006-04-12
• Study First Submitted QC: 2006-04-12
• Study First Posted: 2006-04-13
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-19
• Last Update Posted: 2017-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL