NCT00229177

CompletedPhase 2/3

Study of ONO-2506 in Patients With Acute Ischemic Stroke

Ono Pharmaceutical Co., Ltd.Source

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Other study identifiers

Sponsor study identifier

ONO-2506-08

Study Type

interventional

Actual enrollment (reported)

757

Locations

1 country

Sites

9

Timeline

Study Start

September 2005

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

September 2008

Actual (reported)

Study Completion

September 2008

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 757 participants
Study completion date: September 2008
Actual (reported)
Listed locations: 1 countries · 9 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
September 2005
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 27, 2005
Actual (reported)
First Posted
September 29, 2005
Actual (reported)
Primary Completion
September 2008
Actual (reported)
Study Completion
September 2008
Actual (reported)

Last Updated: June 13, 2012
Status Verified: June 2012
Last Update Submitted: 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

ONO-2506Drug

Once daily one-hour intravenous infusion at 0 mg/kg/hr for 7 days

P

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:

Sponsors & Collaborators

Ono Pharmaceutical Co., Ltd.
Industrylead

Study Sites (9)

Chugoku Region Facility

Chugoku, Japan

Chubu Region Facility

Chūbu, Japan

Hokkaido Region Facility

Hokkaido, Japan

Hokuriku Region Facility

Hokuriku, Japan

Kanto Region Facility

Kanto, Japan

Kinki Region Facility

Kinki, Japan

Kyushu Region Facility

Kyushu, Japan

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

Enrollment

757 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2 3
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 2005

Date type not reported

This date has not been verified as actual or estimated.

NCT00849303

Multicenter Rehabilitation Study in Acute Stroke

Phase 2/3Unknown

NCT00933868

Magnesium Chloride Versus Placebo in Patients Who Have Had a Stroke

Phase 2/3Completed

NCT02849613

Regenerative Stem Cell Therapy for Stroke in Europe

Phase 2/3Withdrawn

NCT02422173

Transcranial Direct Current Stimulation on the Risk of Falls and Lower Limb Function for Acute Stroke

Phase 2/3Completed

NCT03172026

Maraviroc to Augment Rehabilitation Outcomes After Stroke

Phase 2/3Terminated

NCT02910024

Theta-Burst-Stimulation in Early Rehabilitation of Stroke

Phase 2/3Completed

ONO-2506Drug

Once daily one-hour intravenous infusion at 8 mg/kg/hr for 7 days

E1

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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.

Shikoku Region Facility

Shikoku, Japan

Tohoku Region Facility

Tohuku, Japan

Primary Completion

September 2008

Actual (reported)

Study Completion

September 2008

Actual (reported)

Last Updated

June 13, 2012

Record last verified: 2012-06

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00229177
Data provider: ClinicalTrials.gov
Source updated: 2012-06-13
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:26:22 UTC

Locations

JP(9)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (3)

P

E1

E2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (9)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations