Trial · Interventional

CompletedPhase 1/2Results postedRegistry data

Dl-3-n-butylphthalide and Cerebrolysin Treatment in Acute Ischemic Stroke

NCTNCT02149875Other id605872

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 1/2
Enrollment: 84 participants (actual)
Sponsor: Shanghai 6th People's Hospital · Other
Design: Randomized · Triple masking
Countries: 1 country
China
Start: Jan 2010
Primary completion: May 2010
Completion: May 2010
First posted: 29 May 2014 (estimated)
Last update posted: 24 Aug 2020
Conditions: Acute Cerebral Stroke Within 12 Hours for the First Time

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20102011

Ph 1/2
Dl-3-n-butylphthalide and Cerebrolysin Treatment in Acute Ischemic Stroke
NCT02149875
Jan 2010 to May 2010

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Dl-3-n-butylphthalideDrug
CerebrolysinDrug
PlaceboDrug

Arms3

Experimental
Dl-3-n-butylphthalide
Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days
Experimental
Cerebrolysin
Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days
Placebo comparator
Placebo
Intravenous infusion of 100 ml saline intravenous q.d. for 10 days

Primary outcomes1

Outcomes the sponsor listed as primary.

National Institutes of Health Stroke Scale Score
Time frame · At 11-day and 21-day after therapy
Registry description
Scores range from 0 to 42, with higher scores indicating increasing severity

Secondary outcomes(1)

Barthel Index Score
Time frame · At 11-day and 21-day after therapy
Registry description
Range from 0, indicating complete dependence on help with activities of daily living, to 100, indicating independence

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· At 11-day and 21-day after therapy

National Institutes of Health Stroke Scale Score

Group	Value (units on a scale)	Spread
Dl-3-n-butylphthalide	8.78	2.48
Cerebrolysin	7.80	5.81
Placebo	8.85	4.43

Secondary and other outcome results(1)

Secondary outcomeMean· At 11-day and 21-day after therapy

Barthel Index Score

Group	Value (units on a scale)	Spread
Dl-3-n-butylphthalide	35.25	10.57
Cerebrolysin	36.00	10.81
Placebo	31.00	8.68

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Dl-3-n-butylphthalideIntravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days.	–	8 / 20	16 / 20
CerebrolysinIntravenous infusion of 30 ml cerebrolysin q.d. for 10 days.	–	7 / 20	12 / 20
PlaceboIntravenous infusion of 100 ml saline intravenous q.d. for 10 days.	–	11 / 20	12 / 20

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

PubMed tag: none · 2016

6 results

Efficacy and safety comparison of DL-3-n-butylphthalide and Cerebrolysin: Effects on neurological and behavioral outcomes in acute ischemic stroke.

Xue et al. 2016Experimental and therapeutic medicinecited by 56

PMID 27168844PMC4840538DOI 10.3892/etm.2016.3139PUB-27168844

Rights unknown6 results

Source link See results (6)

Eligibility

Who could join, as posted.

Sex: All
Age: from 30 Years up to 90 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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