NCT00314288

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).

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2002

Shorter than P25 for phase_2

Geographic Reach
11 countries

51 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2003

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

April 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 13, 2006

Completed
Last Updated

January 23, 2017

Status Verified

January 1, 2017

First QC Date

April 12, 2006

Last Update Submit

January 19, 2017

Conditions

Parkinson's DiseaseDyskinesia

Keywords

Parkinson's DiseaseDyskinesiaL-dopa-induced dyskinesia

Interventions

Sarizotan HClDRUG

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (51)

Unknown Facility

Fountain Valley, California, United States

Location

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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

Location

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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

Location

MeSH Terms

Conditions

Parkinson DiseaseDyskinesias

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 12, 2006

First Posted

April 13, 2006

Study Start

July 1, 2002

Study Completion

July 1, 2003

Last Updated

January 23, 2017

Record last verified: 2017-01

Locations

US(17)HU(3)CA(3)ZA(5)FR(5)DE(7)BU(1)RO(3)BE(1)PT(2)GB(4)