NCT00229177

Brief Summary

The purpose of this study is to determine the efficacy and safety of ONO-2506 compared to placebo in patients with acute ischemic stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
757

participants targeted

Target at P75+ for phase_2 stroke

Timeline
Completed

Started Sep 2005

Typical duration for phase_2 stroke

Geographic Reach
1 country

9 active sites

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

September 1, 2005

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 29, 2005

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

June 13, 2012

Status Verified

June 1, 2012

Enrollment Period

3 years

First QC Date

September 27, 2005

Last Update Submit

June 12, 2012

Conditions

Stroke

Keywords

ONO-2506strokeAcute ischemic stroke

Outcome Measures

Primary Outcomes (1)

  • Modified Rankin Scale at 90 days

    90 days

Secondary Outcomes (2)

  • Modified Rankin Scale at 30 days

    30 days

  • National Institutes of Health Stroke Scale (NIHSS), Barthel Index (BI), and Glasgow Outcome Scale (GOS) at 90 days

    90 days

Study Arms (3)

P

PLACEBO COMPARATOR
Drug: ONO-2506

E1

EXPERIMENTAL
Drug: ONO-2506

E2

EXPERIMENTAL
Drug: ONO-2506

Interventions

ONO-2506DRUG

Once daily one-hour intravenous infusion at 12/mg/kg/hr for 7 days

E2

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects who have a clinical diagnosis of acute ischemic stroke
  • Subjects within 72 hours after onset of the stroke

You may not qualify if:

  • Subjects who are scheduled to have surgical operations likely to affect the prognosis (including intravascular surgery and circulatory reconstruction)
  • Subjects who are pregnant or lactating, or who have child-bearing potential, or who wish to become pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Chugoku Region Facility

Chugoku, Japan

Location

Chubu Region Facility

Chūbu, Japan

Location

Hokkaido Region Facility

Hokkaido, Japan

Location

Hokuriku Region Facility

Hokuriku, Japan

Location

Kanto Region Facility

Kanto, Japan

Location

Kinki Region Facility

Kinki, Japan

Location

Kyushu Region Facility

Kyushu, Japan

Location

Shikoku Region Facility

Shikoku, Japan

Location

Tohoku Region Facility

Tohuku, Japan

Location

MeSH Terms

Conditions

StrokeIschemic Stroke

Interventions

ONO2506

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Project Leader, Development Planning

    Ono Pharmaceutical Co. Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2005

First Posted

September 29, 2005

Study Start

September 1, 2005

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

June 13, 2012

Record last verified: 2012-06

Locations

JP(9)