Sarizotan in Parkinson Patients With L-dopa-induced Dyskinesia

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 2

Conditions: Parkinson's Disease; Dyskinesia

Treatments: Drug: Sarizotan HCl

Study type: Interventional

Funder types: Industry

Identifiers

NCT00314288

EMR 62225-006

Details and patient eligibility

About

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).

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind