Stroke
Conditions
Keywords
Acute Ischemic Stroke, 9-Hour window MRI, Serotonin receptor agonist
Brief summary
This research study is designed to evaluate the safety, tolerability, and efficacy of SUN N4057 (piclozotan) in subjects with acute ischemic stroke within 9 hours of the onset of symptoms.
Detailed description
The primary objective of the study is to determine the efficacy of a 72 hour infusion of SUN N4057 (piclozotan) in subjects with clinical findings of an acute ischemic stroke and a magnetic resonance imaging (MRI) demonstrating a measurable penumbra (perfusion-weighted imaging \[PWI\] minus diffusion-weighted imaging \[DWI\] volume). Efficacy will be determined by comparing the proportion of subjects with no growth in stroke lesion volume as assessed by DWI at Screening to stroke lesion volume assessed by FLAIR (fluid-attenuated inversion recovery) on Day 28 in the piclozotan group versus the placebo group.
Interventions
DRUGpiclozotan low dose
Continuous IV infusion over a period of up to 72 hours of piclozotan
DRUGplacebo
Continuous IV infusion over a period of up to 72 hours of placebo.
DRUGpiclozotan high dose
Continuous IV infusion over a period of up to 72 hours of piclozotan
Sponsors
Daiichi Sankyo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
General inclusion criteria: * Males or females \>= 18 and \<= 85 years of age at randomization. Female subjects must be either: * Surgically sterile; * Postmenopausal for at least 1 year; or * Non-pregnant, confirmed by a serum pregnancy test, and using a method of birth control that is acceptable to the investigator. * Neurological examination demonstrating localizing cortical signs * Receipt of study drug less than 6 hours (50% of subjects) or between 6 and 9 hours, inclusive, (50% of subjects) after the onset of symptoms (for un-witnessed stroke, last time seen in normal state or at bedtime for un-witnessed stroke during sleep) * Signed informed consent from subject or legally acceptable representative * NIHSS score of 6 - 22, inclusive, or at least 2 on the aphasia item of the NIHSS with a location of MRI findings consistent with aphasia MRI-determined inclusion criteria: * Acute ischemic stroke with substantial cortical involvement in the middle cerebral artery (MCA) distribution, as verified by the Screening DWI abnormality and/or Screening PWI abnormality. (Note: white matter involvement, in addition to cortex, is not an exclusion.)
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in MRI | 28 days |
Secondary
| Measure | Time frame |
|---|---|
| The change in stroke lesion volume from Screening to day 28 | 28 days |
| Clinical outcomes at Days 28 and 90 using the individual clinical scales (Modified Rankin Scale, Barthel Index, and National Institutes of Health Stroke Scale [NIHSS]). | Days 28 and 90 |
| To assess the safety and tolerability of SUN N4057 (piclozotan) in subjects with acute stroke. | Days 28, 60 and 90 |
Countries
Belgium, Germany, Israel, Poland, South Africa, Spain, United States
Outcome results
None listed