A Study to Evaluate the Efficacy and Safety of CP-101,606 in Subjects With an Acute Stroke

A Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of a 72-Hour Infusion of CP-101,606 in Subjects With Acute Ischemic Stroke.

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00073476

Enrollment

300

Registered

2003-11-24

Start date

2003-09-30

Completion date

2005-02-28

Last updated

2006-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Brief summary

The purpose of this study is to determine whether a new research medication is effective and safe for the treatment of acute stroke when given within 6 hours of the onset of stroke.

Interventions

DRUGtraxiprodil (CP-101,606)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

40 Years to 90 Years

Healthy volunteers

Inclusion criteria

Males & females age 40-90 years Enrolled in study within 6 hours of onset of stroke symptoms Willing to sign informed consent form No significant disabilities prior to stroke

Exclusion criteria

Treatment with t-PA (tissue plasminogen activator) Premorbid modified rankin scale score of 2 or more

Design outcomes

Primary

Measure	Time frame
No or minimal neurological deficit at last visit	—
Marked neurological improvement at last visit	—

Secondary

Measure	Time frame
Modified Rankin scale at last visit	—
Mortality	—
Safety assessments	—

Countries

Estonia, Germany, Hungary, Italy, Portugal, Singapore, Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026