NCT00046761TerminatedPhase 2
A Study to Evaluate the Effects of ONO-2506 Intravenous Infusion in Patients With Acute Ischemic Stroke
Ono Pharma USA Inc295 sites in 1 country1,320 target enrollmentStarted: November 1, 2002Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Ono Pharma USA Inc
- Enrollment
- 1,320
- Locations
- 295
- Primary Endpoint
- Modified Rankin Scale
Study Overview
Brief Summary
The primary objective of this study is to compare the efficacy of ONO-2506 versus placebo in neurological stroke outcome in patients with acute ischemic stroke.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient must have a clinical diagnosis of acute cortical ischemic stroke.
- •Patient must be randomized into the study within six hours after the initial onset of stroke symptoms.
- •Patient must have a measurable focal neurological deficit for a minimum duration of 60 minutes.
- •Patient must have a CT or MRI examination compatible with the clinical diagnosis of acute ischemic stroke.
- •Patient must have had a pre-stroke mRS scale score of 0 or
- •Other inclusion criteria as specified in the study protocol.
Exclusion Criteria
- •Patient must not have a body weight of more than 125 kg.
- •Patient must not have a CT and/or MRI with evidence of a non-ischemic mechanism, subarachnoid hemorrhage, or primary intracerebral and/or intraventricular hemorrhage.
- •Patient must not have all three of the following findings:
- •reduced level of consciousness (has score of greater than or equal to two on NIHSS Question 1a)
- •forced eye deviation or total gaze paresis (has score of 2 on NIHSS Question 2) and
- •dense hemiplegia (no movement) of upper and lower extremities (i.e., has score of 4 on NIHSS Question 5 regarding motor arm and has score of 4 on NIHSS Question 6 regarding motor leg).
- •Patient must not have neurological signs and symptoms that are rapidly improving.
- •Patient must not have a severe coexisting or terminal systemic disease.
- •Patient must not be pregnant or lactating.
- •Patient must not have impaired hepatic function; bilirubin greater than 2 mg/dL and or ascites.
- •Patient must not have impaired renal function; serum creatinine greater than 2 mg/dL.
- •Patient must not have congestive heart failure.
- •Patient must not have a baseline ECG showing a PR interval greater than 200 milliseconds, or a corrected QT interval of greater than 480 milliseconds, or a history of ventricular arrhythmias, or a Mobitz Type 1 or greater AV block.
- •Patient must not have other exclusion criteria as specified in the study protocol.
Outcomes
Primary Outcomes
Modified Rankin Scale
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (295)
Loading locations...
Similar Trials
Completed
Phase 2
Study of ONO-2506 in Patients With Acute Ischemic StrokeStrokeNCT00229177Ono Pharmaceutical Co. Ltd757
Completed
Phase 2
Placebo Controlled Study of ONO2506PO in the Presence of Riluzole in Patients With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis (ALS)NCT00403104Ono Pharmaceutical Co. Ltd420
Completed
Phase 1
Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-6950 in Healthy Adult SubjectsHealthy Adult SubjectsNCT01297582Ono Pharma USA Inc56
Completed
Phase 2
Study of NNZ-2566 in Patients With Traumatic Brain InjuryBrain InjuriesNCT00805818Neuren Pharmaceuticals Limited261
Completed
Phase 2
Study of NNZ-2566 in Patients With Traumatic Brain Injury Under EFICBrain InjuriesNCT01366820Neuren Pharmaceuticals Limited261