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

This study has been completed.

First Received on September 9, 2005. Last Updated on 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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind 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

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease Perry syndrome

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Traxoprodil

U.S. FDA Resources

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:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

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

Additional relevant MeSH terms:

Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

N-Methylaspartate
Excitatory Amino Acid Agonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012