Phase ⅡStudy of Pinocembrin Injection to Treat Ischemic Stroke

CSPC Pharmaceutical Group

Status and phase: Suspended; Phase 2

Conditions: Ischemic Stroke

Treatments: Drug: Pinocembrin for Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT02059785

CSPC-HA1301

Details and patient eligibility

About

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

Full description

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

Enrollment: 216 estimated patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No 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 exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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216 participants in 2 patient groups, including a placebo group

Pinocembrin for Injection

Experimental group

Description:

40mg /60mg in 100ml of a solution of 0.9 percent saline,iv.drip bid,14day

Treatment:

Drug: Pinocembrin for Injection

placebo

Placebo Comparator group

Description:

60mg in 100ml of a solution of 0.9 percent saline,iv.drip bid,14day

Treatment:

Drug: Pinocembrin for Injection