Phase 2
Completed N=84
Dl-3-n-butylphthalide and Cerebrolysin Treatment in Acute Ischemic Stroke
Acute Cerebral Stroke Within 12 Hours for the First Time
Source: ClinicalTrials.gov NCT02149875 ↗
Enrolled (actual)
84
Serious AEs
43.3%
Results posted
May 2016
Primary outcomePrimary: National Institutes of Health Stroke Scale Score — 8.78; 7.80; 8.85; 5.48 units on a scale
Summary
The investigators conducted a randomized, double-blind, trial enrolled 60 patients within 12 hours of acute ischemic stroke (AIS) in China. Patients were randomly assigned to receive a 10-day infusion of dl-3-n-butylphthalide (NBP) or cerebrolysin, or placebo. National Institutes of Health Stroke Scale (NIHSS) and Barthel Index (BI) were used to evaluate the efficacy in the patients with AIS at 11-day and 21-day after therapy. Adverse events were also analyzed among the three groups.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY National Institutes of Health Stroke Scale Score |
8.78; 7.80; 8.85; 5.48; 5.90; 7.30 | — |
| SECONDARY Barthel Index Score |
35.25; 36.00; 31.00; 54.00; 53.75; 43.75 | — |
Eligibility Criteria
Inclusion Criteria
- Acute ischemic stroke within 12 hours for the first time before entry into the study
- National Institutes of Health Stroke Scale (NIHSS) score between 6 and 25
Exclusion Criteria
- with lacunar infarction
- with cerebral hemorrhagic infarction
- with epilepsy or epileptic persons
- with history of neurological diseases
- with myocardial infarction,
- with renal and hepatic abnormalities
- with metabolic diseases
- with contraindications to antiplatelet treatments
Data sourced from ClinicalTrials.gov (NCT02149875). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.