Sarizotan in Parkinson Patients With L-dopa-induced Dyskinesia

NCT ID: NCT00314288

Last Updated: 2017-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2003-07-31

Brief Summary

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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

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Conditions

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Parkinson's Disease Dyskinesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Sarizotan HCl

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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EMD Serono

INDUSTRY

Sponsor Role lead

Locations

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Fountain Valley, California, United States

Site Status

Sunnyvale, California, United States

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Miami, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Chicago, Illinois, United States

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Augusta, Maine, United States

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Boston, Massachusetts, United States

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Kansas City, Missouri, United States

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Brooklyn, New York, United States

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New York, New York, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Philadelphia, Pennsylvania, United States

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Pawtucket, Rhode Island, United States

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Memphis, Tennessee, United States

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Houston, Texas, United States

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Leuven, , Belgium

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Sofia, , Bulgaria

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Edmonton, , Canada

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Saskatoon, , Canada

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Vancouver, , Canada

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Clermont-Ferrand, , France

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Marseille, , France

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Nantes, , France

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Paris, , France

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Toulouse, , France

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Bochum, , Germany

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Dresden, , Germany

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Leipzig, , Germany

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Lübeck, , Germany

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München, , Germany

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Ulm, , Germany

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Wiesbaden, , Germany

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Budapest, , Hungary

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Győr, , Hungary

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Miskolc, , Hungary

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Coimbra, , Portugal

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Lisbon, , Portugal

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Bucaresti, , Romania

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Constanța, , Romania

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Târgu Mureş, , Romania

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George, , South Africa

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Plumstead Cape Town, , South Africa

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Rosebank, , South Africa

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Sunninghill, , South Africa

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Wilgers, , South Africa

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Cambridge, , United Kingdom

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Newcastle, , United Kingdom

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Nottingham, , United Kingdom

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Sheffield, , United Kingdom

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Countries

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

Other Identifiers

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EMR 62225-006

Identifier Type: -

Identifier Source: org_study_id

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