Efficacy of BNG-1 to Treat Acute Ischemic Stroke "BNG-1"

Completed

Phase 3 Results N/A

Trial Description

The objective of this study is to investigate the efficacy and safety of BNG-1 in patients with ischemic stroke. The efficacy assessment will be based on the functional outcome while the safety will be reviewed by the adverse events and laboratory examinations.

Detailed Description

The primary endpoint will be performed on the 12 weeks after study drug administered and will compare the favorable rate between treatment with Aspirin alone and combination treatment with BNG-1 and Aspirin in patients with ischemic stroke. The favorable to therapy will be determined if all of the following occurs: alive, Modified Rankin Scale (MRS) < 3, Barthel Index (BI) >= 60.
Secondary objectives are to compare the following:
1. Compare the favorable rate at one week after study drug administered and the end of treatment (Week 4) and 4 weeks of follow-up (Week 8) of either Aspirin alone or combination treatment with BNG-1 and Aspirin.
2. Compare the mean change in Barthel Index (BI), at each evaluation time-point of either Aspirin alone or combination treatment with BNG-1 and Aspirin.
3. Compare the mean change in National Institute of Health Stroke Scale (NIHSS) at each evaluation time-point of either Aspirin alone or combination treatment with BNG-1 and Aspirin.
4. Compare the Modified Rankin Scale (MRS) at each evaluation time-point of either Aspirin alone or combination treatment with BNG-1 and Aspirin.
5. Compare the change in Extended Glasgow Outcome Scale (GOS-E) at each evaluation time-point of either Aspirin alone or combination treatment with BNG-1 and Aspirin.

Conditions

Interventions

  • Aspirin Drug
    Other Names: Aspirin at bedtime
    Intervention Desc: Aspirin 100 mg QD for 4 weeks
    ARM 1: Kind: Experimental
    Label: Aspirin
  • BNG-1 Drug
    Intervention Desc: BNG-1 3 grams TID for 4 weeks
    ARM 1: Kind: Experimental
    Label: BNG-1 plus Aspirin

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Favorable rate 12 weeks No
Primary Mortality 12 weeks No
Primary Modified Rankin Scale 12 weeks No
Primary Barthel Index 12 weeks No
Secondary National Institute of Health Stroke Scale 12 weeks No
Secondary Extended Glasgow Outcome Scale 12 weeks No

Sponsors