Phase 2 Study of NBP For Patients With Acute Ischemic Stroke "SUNRISE"

Recruiting

Phase 2 Results N/A

Trial Description

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.

Detailed Description

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 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.

Conditions

Interventions

  • Aspirin Drug
    Intervention Desc: All arms/randomly assigned subjects will receive Aspirin, 162 mg/day preferred, as the standard supportive medical care for the treatment (162 mg/day preferred)
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: Interventions: Placebo (NBP placebo softgel capsules, 0 mg NBP, BID) Interventions: Aspirin, 162 mg/day preferred, as the standard supportive care
    ARM 2: Kind: Experimental
    Label: 800 mg of NBP daily
    Description: Interventions: 800 mg NBP softgel capsules daily (400 mg BID) Intervention: Aspirin, 162 mg/day preferred, as the standard supportive care
    ARM 3: Kind: Experimental
    Label: 600 mg of NBP daily
    Description: Interventions: 600 mg NBP softgel capsules daily (300 mg BID) Interventions: Aspirin, 162 mg/day preferred, as the standard supportive care
    ARM 4: Kind: Experimental
    Label: 400 mg of NBP daily
    Description: Interventions: 400 mg NBP softgel capsules daily (200 mg BID) Interventions: Aspirin, 162 mg/day preferred, as the standard supportive care
  • Placebo Drug
    Intervention Desc: Take 4 capsules BID on an empty stomach at least 1 hour before food intake, and remain fasting at least 1 hour after dosing
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: Interventions: Placebo (NBP placebo softgel capsules, 0 mg NBP, BID) Interventions: Aspirin, 162 mg/day preferred, as the standard supportive care
  • NBP Softgel Capsules Drug
    Other Names: NBP
    Intervention Desc: Take 4 capsules BID on an empty stomach at least 1 hour before food intake, and remain fasting at least 1 hour after dosing.
    ARM 1: Kind: Experimental
    Label: 800 mg of NBP daily
    Description: Interventions: 800 mg NBP softgel capsules daily (400 mg BID) Intervention: Aspirin, 162 mg/day preferred, as the standard supportive care
    ARM 2: Kind: Experimental
    Label: 600 mg of NBP daily
    Description: Interventions: 600 mg NBP softgel capsules daily (300 mg BID) Interventions: Aspirin, 162 mg/day preferred, as the standard supportive care
    ARM 3: Kind: Experimental
    Label: 400 mg of NBP daily
    Description: Interventions: 400 mg NBP softgel capsules daily (200 mg BID) Interventions: Aspirin, 162 mg/day preferred, as the standard supportive care

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Number of treatment emergent adverse events (TEAE) per subject with mild to moderate cortical AIS characterized by higher cortical dysfunction and/or homonymous visual field defect with limb weakness contralateral to the infarct. 90 days Yes
Primary Change from baseline, relative to placebo group, in the modified Rankin Scale, 9-Question (mRS 9Q) at Day 30. 30 days No
Secondary Change from baseline relative to placebo group in mRS-9Q at Day 90 90 days No
Secondary Change from baseline relative to placebo group in National Institutes of Health Stroke Scale (NIHSS) scores from Day 1 to Day 30 and Day 90 90 days No
Secondary Change from baseline relative to placebo group in Barthel Index (BI) from Day 1 to Day 30 and Day 90 90 days No
Secondary Change in the infarct size at Day 2 and Day 30 30 days No
Secondary Change in the edema volume at Day 3 3 days No
Secondary Change from the baseline in Stroke Impact Scale (SIS) scores at Day 30 and Day 90 90 days No
Secondary Number of treatment emergent adverse events per subject relative to placebo group such as laboratory, vital sign, physical and neurological examination, and electrocardiogram (ECG) parameters, and suicidal tendencies. 90 days Yes
Primary The incidence rate of treatment-emergent adverse events (TEAEs) 90 days
Primary laboratory assessments, vital sign measurements, physical and neurologic examinations, electrocardiogram (ECG) parameters, and Columbia-Suicide Severity Rating Scale (C-SSRS) 90 days
Secondary PK profile of NBP treatment in subjects with AIS 3 days
Secondary mRS-9Q 90 days
Secondary BI Assessment 90 days
Secondary NIHSS 90 days
Secondary Infarct size 30 days
Secondary Edema volume 3 days
Secondary SIS Assessment 90 days
Primary The primary safety outcome is the incidence rate of treatment-emergent adverse events (TEAEs) 90 days
Primary The secondary safety outcomes include laboratory assessments, vital sign measurements, physical and neurologic examinations, electrocardiogram (ECG) parameters, and Columbia-Suicide Severity Rating Scale (C-SSRS) 90 days
Secondary Exploratory efficacy outcome: mRS-9Q 90 days
Secondary Exploratory efficacy outcome: BI Assessment 90 days
Secondary Exploratory efficacy outcome: NIHSS 90 days
Secondary Exploratory efficacy outcome: Infarct size 30 days
Secondary Exploratory efficacy outcome: Edema volume 3 days
Secondary Exploratory efficacy outcome: SIS Assessment 90 days
Primary Incidence rate of treatment-emergent adverse events (TEAEs) 90 days
Secondary Exploratory efficacy outcome: mRS 90 days

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