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

Ischemic Stroke Clinical Trial

Official title: A Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study to Compare the Functional Outcome and Safety of Treatment With BNG-1 in Combination With Aspirin With That of Aspirin Alone in Ischemic Stroke Recovery

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

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

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke

• NCT number: NCT01675115
• Study type: Interventional
• Source: Chang Gung Memorial Hospital
• Status: Completed
• Phase: Phase 3
• Start date: August 2012
• Completion date: November 2014