Sarizotan in Parkinson Patients With L-dopa-induced Dyskinesia

January 19, 2017 updated by: EMD Serono

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

360

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EMD Serono

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2002

Study Completion

July 1, 2003

Study Registration Dates

First Submitted

April 12, 2006

First Submitted That Met QC Criteria

April 12, 2006

First Posted (Estimate)

April 13, 2006

Study Record Updates

Last Update Posted (Estimate)

January 23, 2017

Last Update Submitted That Met QC Criteria

January 19, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMR 62225-006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson's Disease

Clinical Trials on Sarizotan HCl

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe