StrokePhase 2/3NCT00229177
Study of ONO-2506 in Patients With Acute Ischemic Stroke
A Phase 2/3 study testing ONO-2506 in people with Stroke, run by Ono Pharmaceutical Co., Ltd. at 9 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Stroke
- What is being tested?
- ONO-2506
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 757 participants
- Where
- 9 sitesJapan
- Study dates
- Sep 2005to Sep 2008
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who have a clinical diagnosis of acute ischemic stroke
- Subjects within 72 hours after onset of the stroke
- Other inclusion criteria may apply.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Japan9 sites
Chubu Region Facility
Chūbu
Chugoku Region Facility
Chugoku
Hokkaido Region Facility
Hokkaido
Hokuriku Region Facility
Hokuriku
Kanto Region Facility
Kanto
Kinki Region Facility
Kinki
Kyushu Region Facility
Kyushu
Shikoku Region Facility
Shikoku
Tohoku Region Facility
Tohuku
About this study
Official title: Controlled Study of ONO-2506 in Patients With Acute Ischemic Stroke
The purpose of this study is to determine the efficacy and safety of ONO-2506 compared to placebo in patients with acute ischemic stroke.
- Conditions
- Stroke
- Being tested
- ONO-2506
- Keywords
- ONO-2506, stroke, Acute ischemic stroke
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-2506Drug
Once daily one-hour intravenous infusion at 12/mg/kg/hr for 7 days
ONO-2506Drug
Once daily one-hour intravenous infusion at 0 mg/kg/hr for 7 days
ONO-2506Drug
Once daily one-hour intravenous infusion at 8 mg/kg/hr for 7 days
| Study group | Role | What they receive |
|---|---|---|
| P | Placebo comparator | Not described Receives: Drug: ONO-2506 |
| E1 | Experimental | Not described Receives: Drug: ONO-2506 |
| E2 | Experimental | Not described Receives: Drug: ONO-2506 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale at 90 days
Measured: 90 days
Secondary outcomes (2)
Modified Rankin Scale at 30 days
Measured: 30 days
National Institutes of Health Stroke Scale (NIHSS), Barthel Index (BI), and Glasgow Outcome Scale (GOS) at 90 days
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Ono Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 757 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Project Leader, Development Planning, Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00229177
- Sponsor's protocol ID
- ONO-2506-08
- Status last verified
- Jun 2012
- First submitted
- 27 Sep 2005
- Last updated
- 13 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Study of ONO-2506 in Patients With Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT00229177
- Acronym / sponsor ID
- ONO-2506-08
- Conditions
- Stroke
- Keywords
- ONO-2506, stroke, Acute ischemic stroke
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 757 participants (actual)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 29 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the efficacy and safety of ONO-2506 compared to placebo in patients with acute ischemic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| P | Placebo comparator | Drug: ONO-2506 |
| E1 | Experimental | Drug: ONO-2506 |
| E2 | Experimental | Drug: ONO-2506 |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects who have a clinical diagnosis of acute ischemic stroke
- Subjects within 72 hours after onset of the stroke
- Other inclusion criteria may apply.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONO-2506Once daily one-hour intravenous infusion at 12/mg/kg/hr for 7 days | Drug | E2 |
| ONO-2506Once daily one-hour intravenous infusion at 0 mg/kg/hr for 7 days | Drug | P |
| ONO-2506Once daily one-hour intravenous infusion at 8 mg/kg/hr for 7 days | Drug | E1 |
Primary outcome
Modified Rankin Scale at 90 days
Time frame: 90 days
2 secondary outcomes
Modified Rankin Scale at 30 days
Time frame: 30 days
National Institutes of Health Stroke Scale (NIHSS), Barthel Index (BI), and Glasgow Outcome Scale (GOS) at 90 days
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Project Leader, Development Planning study director
Ono Pharmaceutical Co., Ltd.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ONO-2506 in people with Stroke, run by Ono Pharmaceutical Co., Ltd. at 9 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale at 90 days (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2012.