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Acute Ischemic StrokePhase 2NCT01929096

Compound Edaravone Injection for Acute Ischemic Stroke

A Phase 2 study testing Compound Edaravone Injection and Edaravone Injection in people with Acute Ischemic Stroke, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 28 sites 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

1. To investigate the efficacy and safety of multi-doses Compound Edaravone Injection versus Edaravone Injection for acute ischemic stroke patients; 2. To provide evidence for the design of Compound Edaravone Injection Phase III trial. Read more about this study

Who is it for?
Ages 35 to 75 years
Conditions the study is for
Acute Ischemic Stroke
What is being tested?
Compound Edaravone Injection and Edaravone Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
28 sitesChina
Study dates
Aug 2013to Feb 2015
Phase
Phase 2
Are there results?
None posted in the registry

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 35 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Hospitalized patients, diagnosed of ischemic stroke;
  • Onset of stroke is less than or equal to 48 hours;
  • There are clear signs of neurological deficit: 4≤NIHSS score≤24, and also, the sum of NIHSS score for the upper limb and the lower limb is greater than or equal to 2;
  • Patients signed written inform consent.

Who cannot join

  • Cranial CT scan finds intracranial bleeding disorders: hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage;
  • Iatrogenic stroke;
  • Severe disturbance of consciousness: NIHSS category 1a for consciousness is greater than 1；
  • The mRS score prior to this onset is greater than 1;
  • Transient ischemic attack (TIA);
  • SBP after blood pressure control is still greater than to equal to 220 mmHg, or DBP after blood pressure control is still greater than or equal to 120 mmHg;
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  • Patients with severe mental disorders and dementia;
  • ALT or AST is greater than 2.0×ULN or previously known liver diseases, such as acute hepatitis, chronic active hepatitis, liver cirrhosis;
  • Creatinine clearance is less than 30 ml/min or previously known severe renal diseases;
  • Therapeutic neuroprotective agents have been applied after onset, including commercially available edaravone, nimodipine, ganglioside, citicoline, piracetam, butyl benzene peptides, Urinary Kallidinogenase;
  • Arterial or venous thrombolytic therapy has been applied after onset;
  • With malignant tumors or receiving concurrent antitumor treatment;
  • With severe systemic disease, life expectancy is less than 90 days;
  • Pregnant or lactating women;
  • Participate in other clinical studies within 30 days before randomization;
  • The investigators consider the patients are not suitable for this trial.

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

China28 sites

  • Central Hospital of Baotou

    Baotou, Inner Mongolia, 014040

  • Navy General Hospital of The Chinese PLA

    Beijing, Beijing Municipality, 100048

  • Beijing Tiantan Hospital affiliated to Capital Medical University

    Beijing, Beijing Municipality, 100050

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

  • Hunan Provincial People's Hospital

    Changsha, Hunan, 410005

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400010

  • The First Affiliated Hospital of Third Military Medical University of Chinese PLA

    Chongqing, Chongqing Municipality, 400038

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510080

  • The Second Affiliated Hospital of Haerbin Medical University

    Haerbin, Heilongjiang, 150001

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

  • The Second Hospital of Shandong University

    Jinan, Shandong, 250033

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi, 330006

  • Nanjing First Hospital

    Nanjing, Jiangsu, 210006

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210011

  • Nanjing Brain Hospital

    Nanjing, Jiangsu, 210029

  • Qingdao Municipal Hospital

    Qingdao, Shandong, 266011

  • Shanghai Changzheng Hospital

    Shanghai, Shanghai Municipality, 200003

  • Rui Jin Hospital Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

  • The General Hospital of Shenyang Military, Chinese PLA

    Shenyang, Liaoning, 110016

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, 518036

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

  • Hebei General Hospital

    Shijiazhuang, Hebei, 050051

  • The First Affiliated Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001

  • The Second Affiliated Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001

  • Tianjin People's Hospital

    Tianjin, Tianjin Municipality, 300000

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052

  • Tianjin Huanhu Hospital

    Tianjin, Tianjin Municipality, 300060

  • The Affiliated Hospital of Xuzhou Medical College

    Xuzhou, Jiangsu, 221006

Other trials in China

About this study

Official title: Compound Edaravone Injection for Acute Ischemic Stroke, a Multi-center, Randomized, Double-blind, Multi-dose, Parallel, and Controlled Phase II Trial

  1. To investigate the efficacy and safety of multi-doses Compound Edaravone Injection versus Edaravone Injection for acute ischemic stroke patients;
  2. To provide evidence for the design of Compound Edaravone Injection Phase III trial.
Being tested
Compound Edaravone Injection, Edaravone Injection
Medical subject headings
Ischemic Stroke

What participants receive

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

  • Compound Edaravone InjectionDrug

  • Edaravone InjectionDrug

Study groups in NCT01929096
Study groupRoleWhat they receive
Low-dose groupExperimentalCompound Edaravone Injection, 12.5mg/dose (Edaravone 10mg, (+)-Borneol 2.5mg), one dose every 12 hours, continue for 14 days
Receives: Drug: Compound Edaravone Injection
Medium-dose groupExperimentalCompound Edaravone Injection, 37.5mg/dose (Edaravone 30mg, (+)-Borneol 7.5mg), one dose every 12 hours, continue for 14 days
Receives: Drug: Compound Edaravone Injection
High-dose groupExperimentalCompound Edaravone Injection, 62.5mg/dose (Edaravone 50mg, (+)-Borneol 12.5mg), one dose every 12 hours, continue for 14 days
Receives: Drug: Compound Edaravone Injection
Control groupActive comparatorEdaravone Injection，30 mg/dose, one dose every 12 hours, continues for 14 days
Receives: Drug: Edaravone Injection

What is being measured

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

  1. mRS score on day 90

    Measured: day 90

  2. Change from baseline NIHSS score on day 14

    Measured: day 14

Secondary outcomes (4)

  1. The proportion of patients with NIHSS score 0-1 (including motor function) on day 14, 30, 90

    Measured: day 14, 30, 90

  2. The proportion of patients with Barthel Index (BI) score greater than or equal to 95 on day 14, 30, 90

    Measured: day 14, 30, 90

  3. The Montreal Cognitive Assessment(MoCA) score on day 14, 30, 90

    Measured: day 14, 30, 90

  4. Stroke Impact Scale (SIS) score on day 90

    Measured: day 90

Timeline

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

  1. First posted27 Aug 2013 (estimated)
  2. Study startAug 2013
  3. Primary completionDec 2014
  4. Study completionFeb 2015

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01929096
Sponsor's protocol ID
SIM-23-01
Status last verified
Jul 2015
First submitted
22 Aug 2013
Last updated
3 Jul 2015
Results posted
No
Data monitoring committee
No

Publications

  • Xu J, Wang Y, Wang A, Gao Z, Gao X, Chen H, Zhou J, Zhao X, Wang Y. Safety and efficacy of Edaravone Dexborneol versus edaravone for patients with acute ischaemic stroke: a phase II, multicentre, randomised, double-blind, multiple-dose, active-controlled clinical trial. Stroke Vasc Neurol. 2019 Apr 22;4(3):109-114. doi: 10.1136/svn-2018-000221. eCollection 2019 Sep.

    PubMed 31709115

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Compound Edaravone Injection and Edaravone Injection in people with Acute Ischemic Stroke, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 28 sites 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 4 inclusion and 16 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 3 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

mRS score on day 90 (time frame: day 90). The study lists 2 primary outcomes in all. 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 NCT01929096, 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 3 Jul 2015.

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