Acute Cerebral Stroke Within 12 Hours for the First TimePhase 1/2NCT02149875

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

A Phase 1/2 study testing Dl-3-n-butylphthalide and Cerebrolysin in people with Acute Cerebral Stroke Within 12 Hours for the First Time, run by Shanghai 6th People's Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 30 to 90 years
Conditions the study is for: Acute Cerebral Stroke Within 12 Hours for the First Time
What is being tested?: Dl-3-n-butylphthalide and Cerebrolysin
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 84 participants
Where: 1 siteChina
Study dates: Jan 2010to May 2010
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai Sixth People's Hospital
Shanghai, 200233

Other trials in China

About this study

Official title: A Comparison of Safety and Efficacy of Dl-3-n-butylphthalide and Cerebrolysin on Neurological and Behavioral Outcomes in Acute Ischemic Stroke: a Randomized, Double-blind Study.

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.

Conditions: Acute Cerebral Stroke Within 12 Hours for the First Time
Being tested: Dl-3-n-butylphthalide, Cerebrolysin, Placebo
Keywords: Acute ischemic stroke, Dl-3-n-butylphthalide, Cerebrolysin
Medical subject headings: Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dl-3-n-butylphthalideDrug
Also called CSPC NBP Pharmaceutical Co., Ltd., Shijiazhuang, China
Intravenous infusion of 100 ml dl-3-n-butylphthalide and sodium chloride injection for 10 days, twice daily.
CerebrolysinDrug
Also called Ever Pharma, Unterach am Attersee, Austria
Intravenous infusion of 30 ml Cerebrolysin per day in 100 ml normal saline for 10 days.
PlaceboDrug
Also called Hebei Tiancheng Pharmaceutical Co., Ltd., Cangzhou, China
100 ml saline intravenous infusion once daily for 10 days.

Study groups in NCT02149875
Study group	Role	What they receive
Dl-3-n-butylphthalide	Experimental	Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days Receives: Drug: Dl-3-n-butylphthalide
Cerebrolysin	Experimental	Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days Receives: Drug: Cerebrolysin
Placebo	Placebo comparator	Intravenous infusion of 100 ml saline intravenous q.d. for 10 days Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2010May 2010

First posted29 May 2014 (estimated)
Study startJan 2010
Primary completionMay 2010
Study completionMay 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Acute Cerebral Stroke Within 12 Hours for the First TimeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02149875
Sponsor's protocol ID: 605872
Status last verified: Aug 2020
First submitted: 16 May 2014
Last updated: 24 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Xue LX, Zhang T, Zhao YW, Geng Z, Chen JJ, Chen H. Efficacy and safety comparison of DL-3-n-butylphthalide and Cerebrolysin: Effects on neurological and behavioral outcomes in acute ischemic stroke. Exp Ther Med. 2016 May;11(5):2015-2020. doi: 10.3892/etm.2016.3139. Epub 2016 Mar 10.
PubMed 27168844

Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Comparison of Safety and Efficacy of Dl-3-n-butylphthalide and Cerebrolysin on Neurological and Behavioral Outcomes in Acute Ischemic Stroke: a Randomized, Double-blind Study.
ClinicalTrials.gov ID: NCT02149875
Acronym / sponsor ID: 605872
Conditions: Acute Cerebral Stroke Within 12 Hours for the First Time
Keywords: Acute ischemic stroke, Dl-3-n-butylphthalide, Cerebrolysin
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 84 participants (actual)
Lead sponsor: Shanghai 6th People's HospitalUniversity, hospital or other
Study start: Jan 2010
Primary completion: May 2010 (actual)
Study completion: May 2010 (actual)
First posted: 29 May 2014 (estimated)
Results: Posted 18 May 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Dl-3-n-butylphthalide	Experimental	Drug: Dl-3-n-butylphthalideIntravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days
Cerebrolysin	Experimental	Drug: CerebrolysinIntravenous infusion of 30 ml cerebrolysin q.d. for 10 days
Placebo	Placebo comparator	Drug: PlaceboIntravenous infusion of 100 ml saline intravenous q.d. for 10 days

Who may qualify

Ages: 30 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (8 listed)

with lacunar infarction
with cerebral hemorrhagic infarction
with epilepsy or epileptic persons
with history of neurological diseases
with myocardial infarction,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dl-3-n-butylphthalideAlso: CSPC NBP Pharmaceutical Co., Ltd., Shijiazhuang, ChinaIntravenous infusion of 100 ml dl-3-n-butylphthalide and sodium chloride injection for 10 days, twice daily.	Drug	Dl-3-n-butylphthalide
CerebrolysinAlso: Ever Pharma, Unterach am Attersee, AustriaIntravenous infusion of 30 ml Cerebrolysin per day in 100 ml normal saline for 10 days.	Drug	Cerebrolysin
PlaceboAlso: Hebei Tiancheng Pharmaceutical Co., Ltd., Cangzhou, China100 ml saline intravenous infusion once daily for 10 days.	Drug	Placebo

Primary outcome

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

1 secondary outcome

Barthel Index Score
Time frame: At 11-day and 21-day after therapy

Results and safety

Results posted to the registry on 18 May 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dl-3-n-butylphthalide	27	20
Cerebrolysin	28	20
Placebo	29	20

Primary outcome: National Institutes of Health Stroke Scale Score

Time frame: At 11-day and 21-day after therapy. Mean (Standard Deviation). Unit: units on a scale

Measure	Dl-3-n-butylphthalide n = 20	Cerebrolysin n = 20	Placebo n = 20
Day 11	8.78 (2.48)	7.80 (5.81)	8.85 (4.43)
Day 21	5.48 (2.34)	5.90 (3.96)	7.30 (4.78)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 21 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dl-3-n-butylphthalide	8 of 20 (40%)	16 of 20 (80%)	Not reported
Cerebrolysin	7 of 20 (35%)	12 of 20 (60%)	Not reported
Placebo	11 of 20 (55%)	12 of 20 (60%)	Not reported

Limitations and caveats (from the sponsor): Foremost is the relatively small sample size, and only patients with moderate severity of stroke were enrolled, so the efficacy results of this study should be interpreted with caution.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27168844Xue LX, Zhang T, Zhao YW, Geng Z, Chen JJ, Chen H. Efficacy and safety comparison of DL-3-n-butylphthalide and Cerebrolysin: Effects on neurological and behavioral outcomes in acute ischemic stroke. Exp Ther Med. 2016 May;11(5):2015-2020. doi: 10.3892/etm.2016.3139. Epub 2016 Mar 10.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lixia Xue, M.D., Ph.D. study director

Shanghai 6th People's Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Dl-3-n-butylphthalide and Cerebrolysin in people with Acute Cerebral Stroke Within 12 Hours for the First Time, run by Shanghai 6th People's Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

National Institutes of Health Stroke Scale Score (time frame: At 11-day and 21-day after therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02149875, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2020.