This is a Phase 2 multicenter, randomized, double-blind, placebo-controlled, add-on to standard of care study of NBP softgel capsules for the treatment of mild to moderate AIS in adults.
This is a randomized, double-blind, placebo-controlled, add-on to standard-of-care study with a primary objective to assess the safety of NBP treatment in patients with mild to moderate acute ischemic stroke. The secondary objectives include determination of pharmacokinetic (PK) profile and exploratory evaluation for the efficacy of NBP treatment in stroke patients. All randomized subjects will also receive standard supportive medical care for treatment of AIS throughout the study. The overall duration of the study will be approximately 90 days, including 30 days of treatment and an additional 60 days for follow up assessments. Subjects will be hospitalized long enough to receive the first four doses of study drug. After discharge from the hospital, subjects will continue to take study treatment daily through Day 30 and have scheduled assessments completed. To maintain the blind, all subjects will take 4 softgel capsules BID, which will contain either 100 mg NBP or matching placebo. The first dose must be taken within 12 hours of the onset of the AIS defined as the last known normal.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
177
Take 4 capsules BID on an empty stomach at least 1 hour before food intake, and remain fasting at least 1 hour after dosing.
Take 4 capsules BID on an empty stomach at least 1 hour before food intake, and remain fasting at least 1 hour after dosing
Investigative Site
Los Angeles, California, United States
Investigative Site
Los Angeles, California, United States
Incidence rate of treatment-emergent adverse events (TEAEs)
Safety will be evaluated through the collection of TEAEs, serious adverse events (SAEs), clinical laboratory assessments, vital sign measurements, 12-lead ECGs, and physical and neurologic examinations. Suicidality will be evaluated at each clinical visit using the Columbia-Suicide Severity Rating Scale (C-SSRS).
Time frame: 90 days
PK profile of NBP treatment in subjects with AIS
Peak and trough levels of NBP and metabolites
Time frame: 1 day
Exploratory efficacy outcome: mRS
Improvement of disability as measured by the mRS at Day 30 and Day 90
Time frame: 90 days
Exploratory efficacy outcome: Barthel Index (BI) Assessment
Stroke recovery as measured by the BI Assessment at Day 30 and Day 90
Time frame: 90 days
Exploratory efficacy outcome: NIHSS
Stroke recovery as measured by the NIHSS at Day 30 and Day 90
Time frame: 90 days
Exploratory efficacy outcome: Stroke Impact Scale (SIS) Assessment
SIS-16 on study Day 30 and 90
Time frame: 90 days
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Investigative Site
Jacksonville, Florida, United States
Investigative Site
Des Moines, Iowa, United States
Investigative Site
Louisville, Kentucky, United States
Investigative Site
Boston, Massachusetts, United States
Investigative Site
Golden Valley, Minnesota, United States
Investigative Site
St Louis, Missouri, United States
Investigative Site
Omaha, Nebraska, United States
Investigative Site
Buffalo, New York, United States
...and 11 more locations