NCT00163085

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

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

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

September 22, 2006

Status Verified

September 1, 2006

First QC Date

September 9, 2005

Last Update Submit

September 21, 2006

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • Dyskinesia Rating Scale

Secondary Outcomes (1)

  • Fingertapping

Interventions

NR2B NMDA Antagonist CP-101,606 (traxoprodil)DRUG

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Portland, Oregon, 97239, United States

Location

Related Links

MeSH Terms

Conditions

Parkinson Disease

Interventions

traxoprodil mesylate

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 13, 2005

Study Start

May 1, 2005

Study Completion

January 1, 2006

Last Updated

September 22, 2006

Record last verified: 2006-09

Locations

US(1)