Phase ⅡStudy of Pinocembrin Injection to Treat Ischemic Stroke

Phase ⅡStudy of Pinocembrin Injection to Treat Ischemic Stroke---Randomized, Double-blind, Placebo-controlled, Multicenter Study

Status

Suspended

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02059785

Enrollment

216

Registered

2014-02-11

Start date

2013-06-30

Completion date

2016-12-31

Last updated

2016-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

Keywords

Pinocembrin for Injection, Placebo, mRS

Brief summary

This research is a Randomized, double-blind, placebo-controlled, multicenter clinical study. Chinese subjects with Ischemic Stroke.

Detailed description

Subjects will randomly enter into one of two groups,the period of treatment is 14 days,follow-up to the 90th days.

Interventions

DRUGPinocembrin for Injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

35 Years to 75 Years

Healthy volunteers

Inclusion criteria

* 35-75 hospitalized patients * Patients with acute stroke ≤24h * NIHSS score 6-20 at time of enrollment , the score ≥2 of item 5 and/or 6 * For the first time or always without obvious sequelae of stroke disease(mRS≤1） * Informed consent

Exclusion criteria

* The disease such as Acute intracerebral hemorrhage,tumor and encephalitis which cause similar symptoms * Patient with NIHSS level of consciousness score≥2 or dementia,or other patients who the investigator think that don't fit into the study * TIA * Symptoms of disease rapidly improving during the randomized * Severe hypertension(SBP \> 200 mmHg or DBP \>110 mmHg) * Inadequate liver function(AST or ALT greater than 2 times the upper limit of normal values);Renal impairment (Creatinine clearance \<60ml/min） * Severe system or viscera organic disease * Have used other neuroprotectant or other experimental drugs * Patient who are unlikely to complete the study that due to a severe clinical condition * Pregnant or breast-feeding * Participation in a previous clinical study within 30 days * Meets all other

Design outcomes

Primary

Measure	Time frame
To determination the proportion of subjects that 0-1 score of mRS after treatment 90 days	90 days

Secondary

Measure	Time frame
To compare treatment arms in terms of change from baseline to endpoint in NIHSS score.	90 days

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026