BIP_CSPC-NBP-2001 PSV

BIP CSPC-NBP-2001 PSV - A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Add-On to Standard-of-Care Study of n-Butylphthalide (NBP) Softgel Capsules for Treatment of Mild to Moderate Acute Ischemic Stroke in Adult Subjects

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.

Key Eligibilities:
-A clinical diagnosis of mild to moderate cortical or subcortical acute ischemic stroke (AIS) with a standard NIHSS score of 4 to 17, inclusive. If patients receive tPA and/or EVT, the NIHSS score must be obtained after the procedure is completed. All subjects must meet a NIHSS consciousness score of 0-1 in order to meet eligibility.
-Able to swallow softgel capsules as defined by the investigator.
-Functionally independent, as defined by a Modified Rankin Scale (mRS) score of 0 to 1 before their present illness as determined by the subject or provided by a representative if the subject is unable to participate at the time of study entry (determined by retrospective assessment by the Investigator).

Key Exclusion Criteria:
-Signs of acute hemorrhage or other cause of acute stroke symptoms (other than early ischemic findings) on cranial imaging at Screening.
-Signs of acute hemorrhage or other cause of acute stroke symptoms (other than early ischemic findings) on cranial imaging at Screening.

**Other protocol-defined inclusion/exclusion criteria may apply. Please click on the NCT Number (below) to learn more about the study at clinicaltrials.gov.**
Phase II
NCT02905565
Neurosciences
Stroke
Ted Lowenkopf, M.D.
CSPC-NBP Pharmaceutical Co., Ltd.
Alexis Young
  • Providence St. Vincent Medical Center