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The Effects of an NR2B NMDA Antagonist, CP-101,606, in Patients With Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00163085
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : September 22, 2006
Sponsor:
Information provided by:

Study Description
Brief Summary:
To determine the effects of the NMDA antagonist, CP-101,606, in subjects with Parkinson's Disease

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: NR2B NMDA Antagonist CP-101,606 (traxoprodil) Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Crossover Study To Explore The Efficacy And Safety Of The NR2B NMDA Antagonist CP-101,606 In Patients With Idiopathic Parkinson's Disease
Study Start Date : May 2005
Estimated Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Dyskinesia Rating Scale

Secondary Outcome Measures :
  1. Fingertapping

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 30- 80-year-old PD patients (UK Parkinson's Disease Brain Bank criteria) with a Hoehn & Yahr stage score of 2-5 in the "off" state.

Exclusion Criteria:

  • Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00163085


Locations
United States, Oregon
Pfizer Investigational Site
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00163085     History of Changes
Other Study ID Numbers: A1611007
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: September 22, 2006
Last Verified: September 2006

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases