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NCT00163085 Clinical Trial

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

Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00163085
Other study ID # A1611007
Secondary ID
Status Completed
Phase Phase 2
First received September 9, 2005
Last updated September 21, 2006
Start date May 2005
Est. completion date January 2006

Study information
Verified date September 2006
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date January 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 80 Years
Eligibility 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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• NR2B NMDA Antagonist CP-101,606 (traxoprodil)

Locations
Country Name City State
United States Pfizer Investigational Site Portland Oregon

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Dyskinesia Rating Scale
Secondary Fingertapping
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