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StrokePhase 3CERE-LYSE-1NCT00840671

Combined Treatment With Alteplase (Rt-PA) and Cerebrolysin® in Acute Ischemic Hemispheric Stroke

A Phase 3 study testing Cerebrolysin and 0.9% Saline Solution in people with Stroke, run by Ever Neuro Pharma GmbH at 15 sites in 5 countries.

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

It should be shown that Cerebrolysin in combination with Alteplase, the medication that should recover the blood flow through the brain, is an effective and save medication to treat ischeamic stroke. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Stroke
What is being tested?
Cerebrolysin and 0.9% Saline Solution
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
119 participants
Where
15 sitesin 5 countries
Study dates
Oct 2005to Jul 2008
Phase
Phase 3
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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female or male inpatients.
  • Age: 18-80 years.
  • If female, patient must not be pregnant
  • Clinical diagnosis of ischemic stroke causing a measurable neurological deficit defined as impairment of language, motor function, cognition and/or gaze,vision or neglect. Ischemic stroke is defined as an event characterized by the sudden onset of an acute focal neurologic deficit presumed to be due to cerebral ischemia after CT scan excludes haemorrhage.
  • Onset of symptoms within 3 hours prior to initiation of rt-PA administration.
  • Stroke symptoms are to be present for at least 30 minutes and have not significantly improved before treatment. Symptoms must be distinguishable from an episode of generalized ischemia (i.e. syncope), seizure or migraine disorder.
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  • Patient is willing to participate voluntarily and to sign a written patient informed consent. Informed consent will be obtained from each patient or the subject's legally authorized representative or relatives, or deferred where applicable, according to the regulatory and legal requirements of the participating country.
  • Patients who are unable to sign but who are able to understand the meaning of participation in the study may give an oral witnessed informed consent. These patients have to make clear undoubtful that they are willing to participate voluntarily and must be able to understand an explanation of the contents of the information sheet. A written consent has to be obtained as soon as possible.
  • Willingness and ability to comply with the protocol.

Who cannot join

  • Evidence of intracranial haemorrhage (ICH) on the CT-scan
  • Violation of inclusion criteria not approved by clinical study director or study safety officer
  • Failure to perform or to evaluate screening or baseline examinations
  • Hospitalisation (except for study purposes) or change of concomitant medication 4 weeks prior to screening or during screening period
  • Participation in another therapeutic clinical trial 3 months before baseline
  • Patients with any history of prior stroke and concomitant diabetes
Show all 37Show fewer
  • Prior stroke within the last 3 months
  • Platelet count of below 100x103/mm3
  • Blood glucose <50 or >400 mg/dl (<2.77 or >22.15 mmol/L)
  • Known haemorrhagic diathesis
  • Manifest or recent severe or dangerous bleeding
  • Known bacterial endocarditis, pericarditis
  • Acute pancreatitis
  • Documented ulcerative gastrointestinal disease during the last 3 months, oesophageal varices, arterial-aneurysm, arterial/venous malformation
  • Neoplasm with increased bleeding risk
  • Severe liver disease, including hepatic failure, cirrhosis, portal hypertension, oesaphageal varices) and active hepatitis
  • Major surgery or significant trauma in past 3 months
  • Lab values seriously abnormal, and/or more than 2 lab values abnormal not approved by clinical study director or study safety officer
  • Serious drug allergies
  • Hypersensitivity to one of the components of the drug
  • Severe renal impairment
  • Systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg, or aggressive management (IV medication) necessary to reduce BP to these limits
  • Recent (less than 10 days) traumatic external heart massage, obstetrical delivery, recent puncture of a non-compressible blood-vessel (e.g. subclavian or jugular vein puncture)
  • Chronic intoxication or chronic substance use disorder with pharmaceuticals, drugs, alcohol or industrial poisons
  • Symptoms of ischemic attack began more than 3 hours prior to start of thrombolytic therapy or if time of symptom onset is unknown
  • Minor neurological deficit or symptoms rapidly improving before start of infusion
  • Severe stroke as assessed clinically (e.g. NIHSS >25) and/or by appropriate imaging techniques
  • Epilepsy or epileptic seizure at onset of stroke
  • Symptoms suggestive of subarachnoid haemorrhage, even if the CT-scan is normal
  • Known history of or suspected intracranial haemorrhage
  • Suspected subarachnoid haemorrhage or condition after subarachnoid hemorrhage from aneurysm
  • Any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery)
  • Haemorrhagic retinopathy, e.g. in diabetes (vision disturbances may indicate haemorrhagic retinopathy)
  • Administration of heparin within the previous 48 hours and a thromboplastin time exceeding the upper limit of normal for laboratory
  • Patients receiving oral anticoagulants, e.g. warfarin sodium
  • Special attention should be given to possible additive effects when used in conjunction with anti-depressants or MAO-inhibitors
  • Cerebrolysin should not be mixed with balanced amino acid solutions in an infusion

Trial locations and contacts

15 sites in 5 countries.

15 sites in 5 countries

Austria5 sites

  • Außenstelle Landesklinikum Donauregion Gugging

    Gugging, 3400

  • Universitätsklinik Innsbruck, Dept. of Neurology

    Innsbruck, 6020

  • LKH Klagenfurt, Abteilung für Neurologie

    Klagenfurt, 9020

  • AKH Linz, Abteilung Neurologie & Psychiatrie

    Linz, 4021

  • Krankenhaus der Barmherzigen Brüder/Abteilung für Neurologie

    Vienna, 1020

Other trials in Austria

Croatia4 sites

  • Klinicka Bolnicki Centar, Klinika za Nevrologiju

    Rijeka, 51000

  • Clinical Hospital Split, Dept. of Neurology

    Split, 21000

  • Medical School of Zagreb

    Zagreb, 10000

  • University Hospital Sorrores Misericoridae

    Zagreb, 10000

Other trials in Croatia

Czechia4 sites

  • St. Ann's Hospital, Dept. of Neurology

    Brno, 65691

  • Clinic of Neurology, Faculty Hospital Ostrava

    Ostrava, 70852

  • Blessed Mary Anthony Hospital, Dept. of Neurology

    Ostrava Vitkovice, 70384

  • University Hospital Plzen

    Pilsen, 30460

Other trials in Czechia

Slovakia1 site

  • University Hospital, Comenius University, Dept. of Neurology

    Bratislava, 81369

Other trials in Slovakia

Slovenia1 site

  • Clinical Hospital Centre Ljubljana

    Ljubljana, 1525

Other trials in Slovenia

About this study

Official title: A Prospective, Randomised, Placebo Controlled, Double Blind Trial About Safety and Efficacy of Combined Treatment With Alteplase (Rt-PA) and Cerebrolysin® in Acute Ischemic Hemispheric Stroke

It should be shown that Cerebrolysin in combination with Alteplase, the medication that should recover the blood flow through the brain, is an effective and save medication to treat ischeamic stroke.

Read the detailed description

The current trial should evaluate a combined treatment using Cerebrolysin immediately after thrombolysis to guarantee that the neurotrophic components are able to reach the endangered brain areas efficiently. An early start of treatment should guarantee rescue of most of the neurons reducing the overall damage.The study follows the design of pure thrombolytic trials to investigate, if the early neuroprotective treatment with Cerebrolysin is able to improve the overall outcome of patients at the day 90 evaluation visit. Due to the initial findings special emphasis will be also put on analysing the speed of recovery.

Conditions
Stroke
Being tested
Cerebrolysin, 0.9% Saline Solution
Keywords
Cerebrolysin, Alteplase, Ischemic Stroke, Modified Rankin Scale, NIH Stroke Scale, Barthel Index, Glasgow Outcome Score
Medical subject headings
Stroke, Ischemic Stroke

What participants receive

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

  • CerebrolysinDrug

    Cerebrolysin, 30 ml/day as intravenous infusion, first infusion after completion of thrombolytic therapy. Daily infusion for 10 consecutive days.

  • 0.9% Saline SolutionDrug

    Also called NaCl

    0.9% Saline Solution, 30 ml/day as intravenous infusion, first infusion after completion of thrombolytic therapy. Daily infusion for 10 consecutive days.

Study groups in NCT00840671
Study groupRoleWhat they receive
CerebrolysinExperimentalCerebrolysin, 30 ml/day as intravenous infusion, first infusion after completion of thrombolytic therapy. Daily infusion for 10 consecutive days.
Receives: Drug: Cerebrolysin
0.9% Saline SolutionPlacebo comparator0.9% Saline Solution, 30 ml/day as intravenous infusion, first infusion after completion of thrombolytic therapy. Daily infusion for 10 consecutive days.
Receives: Drug: 0.9% Saline Solution

What is being measured

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

  1. Modified Rankin Scale score at day 90 (or earlier in the event of patient withdrawal).

    Measured: Day 90

Secondary outcomes (4)

  1. NIH Stroke Scale Score 90 days after start of treatment (or earlier in the event of patient withdrawal). Actual score or change from baseline score analysed.

    Measured: 90 days after start of treatment

  2. Glasgow Outcome Score 90 days after start of treatment (or earlier in the event of patient withdrawal). Actual score or change from baseline score analysed.

    Measured: 90 days after start of treatment

  3. Barthel Index Score 90 days after start of treatment (or earlier in the event of patient withdrawal). Actual score or change from baseline score analysed.

    Measured: 90 days after start of treatment

  4. Responders classified according to Barthel Index Score ≥95, Glasgow Outcome Score 0-1, NIHSS change from baseline score, 8 point improvement or total score 0-1 or NIHSS Distal Motor Function Score 0-1. Responder rates across each scale analysed.

Timeline

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

  1. First posted10 Feb 2009 (estimated)
  2. Study startOct 2005
  3. Primary completionMar 2008
  4. Study completionJul 2008

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
119 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00840671
Sponsor's protocol ID
CR040301
Other IDs
EudraCT-number: 2004-001729-11
Acronym
CERE-LYSE-1
Status last verified
Dec 2010
First submitted
9 Feb 2009
Last updated
28 Dec 2010
Results posted
No
Data monitoring committee
No

Publications

  • Lang W, Stadler CH, Poljakovic Z, Fleet D; Lyse Study Group. A prospective, randomized, placebo-controlled, double-blind trial about safety and efficacy of combined treatment with alteplase (rt-PA) and Cerebrolysin in acute ischaemic hemispheric stroke. Int J Stroke. 2013 Feb;8(2):95-104. doi: 10.1111/j.1747-4949.2012.00901.x. Epub 2012 Sep 26.

    PubMed 23009193

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cerebrolysin and 0.9% Saline Solution in people with Stroke, run by Ever Neuro Pharma GmbH at 15 sites in 5 countries.

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 9 inclusion and 37 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 28 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Austria, Croatia, Czechia, Slovakia, Slovenia. 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 phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Modified Rankin Scale score at day 90 (or earlier in the event of patient withdrawal). (time frame: Day 90). 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 NCT00840671, 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 28 Dec 2010.

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