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The Effects of an NR2B NMDA Antagonist, CP-101,606, in Patients With Parkinson's Disease
This study has been completed.
First Received: September 9, 2005   Last Updated: September 21, 2006   History of Changes
Sponsor: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00163085
  Purpose

To determine the effects of the NMDA antagonist, CP-101,606, in subjects with Parkinson's Disease


Condition Intervention Phase
Parkinson's Disease
Drug: NR2B NMDA Antagonist CP-101,606 (traxoprodil)
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Dyskinesia Rating Scale

Secondary Outcome Measures:
  • Fingertapping

Estimated Enrollment: 12
Study Start Date: May 2005
Estimated Study Completion Date: January 2006
  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Study ID Numbers: A1611007
Study First Received: September 9, 2005
Last Updated: September 21, 2006
ClinicalTrials.gov Identifier: NCT00163085     History of Changes
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on February 08, 2010