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NCT00314288 Clinical Trial

Sarizotan in Parkinson Patients With L-dopa-induced Dyskinesia

Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00314288
Other study ID # EMR 62225-006
Secondary ID
Status Completed
Phase Phase 2
First received April 12, 2006
Last updated January 19, 2017
Start date July 2002
Est. completion date July 2003

Study information
Verified date January 2017
Source EMD Serono
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 360
Est. completion date July 2003
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 30 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Sarizotan HCl

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
EMD Serono

Countries where clinical trial is conducted

United States,  Belgium,  Bulgaria,  Canada,  France,  Germany,  Hungary,  Portugal,  Romania,  South Africa,  United Kingdom, 

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