Clinical trial NCT00314288: Sarizotan in Parkinson Patients With L-dopa-induced Dyskinesia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Dyskinesia
Keywords: Parkinson's Disease
Dyskinesia
L-dopa-induced dyskinesia
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
First posted: 2006-04-13
Enrollment: 360
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Fountain Valley
country: United States
state: California
city: Sunnyvale
country: United States
state: California
city: Miami
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Augusta
country: United States
state: Maine
city: Boston
country: United States
state: Massachusetts
city: Kansas City
country: United States
state: Missouri
city: Brooklyn
country: United States
state: New York
city: New York
country: United States
state: New York
city: Cincinatti
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Pawtucket
country: United States
state: Rhode Island
city: Memphis
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Leuven
country: Belgium
city: Sofia
country: Bulgaria
city: Edmonton
country: Canada
city: Saskatoon
country: Canada
city: Vancouver
country: Canada
city: Clermont-Ferrand
country: France
city: Marseille
country: France
city: Nantes
country: France
city: Paris
country: France
city: Toulouse
country: France
city: Bochum
country: Germany
city: Dresden
country: Germany
city: Leipzig
country: Germany
city: Lübeck
country: Germany
city: München
country: Germany
city: Ulm
country: Germany
city: Wiesbaden
country: Germany
city: Budapest
country: Hungary
city: Gyor
country: Hungary
city: Miskolc
country: Hungary
city: Coimbra
country: Portugal
city: Lisbon
country: Portugal
city: Bucaresti
country: Romania
city: Constanta
country: Romania
city: Targu-Mures
country: Romania
city: George
country: South Africa
city: Plumstead Cape Town
country: South Africa
city: Rosebank
country: South Africa
city: Sunninghill
country: South Africa
city: Wilgers
country: South Africa
city: Cambridge
country: United Kingdom
city: Newcastle
country: United Kingdom
city: Nottingham
country: United Kingdom
city: Sheffield
country: United Kingdom
Study officials:
References: