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Study of ONO-2506 in Patients With Acute Ischemic Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
ONO-2506
ONO-2506
ONO-2506
Sponsored by
Ono Pharmaceutical Co. Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring ONO-2506, stroke, Acute ischemic stroke

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjects who have a clinical diagnosis of acute ischemic stroke Subjects within 72 hours after onset of the stroke Other inclusion criteria may apply. Exclusion Criteria: 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. Other exclusion criteria may apply.

Sites / Locations

  • Chubu Region Facility
  • Chugoku Region Facility
  • Hokkaido Region Facility
  • Hokuriku Region Facility
  • Kanto Region Facility
  • Kinki Region Facility
  • Kyushu Region Facility
  • Shikoku Region Facility
  • Tohoku Region Facility

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

P

E1

E2

Arm Description

Outcomes

Primary Outcome Measures

Modified Rankin Scale at 90 days

Secondary Outcome Measures

Modified Rankin Scale at 30 days
National Institutes of Health Stroke Scale (NIHSS), Barthel Index (BI), and Glasgow Outcome Scale (GOS) at 90 days

Full Information

First Posted
September 27, 2005
Last Updated
June 12, 2012
Sponsor
Ono Pharmaceutical Co. Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT00229177
Brief Title
Study of ONO-2506 in Patients With Acute Ischemic Stroke
Official Title
Controlled Study of ONO-2506 in Patients With Acute Ischemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ono Pharmaceutical Co. Ltd

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
ONO-2506, stroke, Acute ischemic stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
757 (Actual)

8. Arms, Groups, and Interventions

Arm Title
P
Arm Type
Placebo Comparator
Arm Title
E1
Arm Type
Experimental
Arm Title
E2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ONO-2506
Intervention Description
Once daily one-hour intravenous infusion at 12/mg/kg/hr for 7 days
Intervention Type
Drug
Intervention Name(s)
ONO-2506
Intervention Description
Once daily one-hour intravenous infusion at 0 mg/kg/hr for 7 days
Intervention Type
Drug
Intervention Name(s)
ONO-2506
Intervention Description
Once daily one-hour intravenous infusion at 8 mg/kg/hr for 7 days
Primary Outcome Measure Information:
Title
Modified Rankin Scale at 90 days
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Modified Rankin Scale at 30 days
Time Frame
30 days
Title
National Institutes of Health Stroke Scale (NIHSS), Barthel Index (BI), and Glasgow Outcome Scale (GOS) at 90 days
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects who have a clinical diagnosis of acute ischemic stroke Subjects within 72 hours after onset of the stroke Other inclusion criteria may apply. Exclusion Criteria: 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. Other exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Project Leader, Development Planning
Organizational Affiliation
Ono Pharmaceutical Co. Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Chubu Region Facility
City
Chubu
Country
Japan
Facility Name
Chugoku Region Facility
City
Chugoku
Country
Japan
Facility Name
Hokkaido Region Facility
City
Hokkaido
Country
Japan
Facility Name
Hokuriku Region Facility
City
Hokuriku
Country
Japan
Facility Name
Kanto Region Facility
City
Kanto
Country
Japan
Facility Name
Kinki Region Facility
City
Kinki
Country
Japan
Facility Name
Kyushu Region Facility
City
Kyushu
Country
Japan
Facility Name
Shikoku Region Facility
City
Shikoku
Country
Japan
Facility Name
Tohoku Region Facility
City
Tohuku
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Study of ONO-2506 in Patients With Acute Ischemic Stroke

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