The Safety and Efficacy of Cerebrolysin in Patients With Acute Ischemic Stroke (CASTA)
This study has been completed.
Sponsor:
Ever Neuro Pharma GmbH
Collaborators:
Excel PharmaStudies, Inc.
idv Datenanalyse und Versuchsplanung
Information provided by:
Ever Neuro Pharma GmbH
ClinicalTrials.gov Identifier:
NCT00868283
First received: March 23, 2009
Last updated: July 6, 2011
Last verified: July 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The study investigated the clinical efficacy and safety of a 10-day course of therapy with daily intravenous administration of 30mL Cerebrolysin based on a comparison with Placebo in patients with acute ischemic stroke. 1070 patients were randomized in this trial in 2 parallel groups, one receiving Cerebrolysin, the control group receiving Placebo. Study drug will be given once daily by intravenous infusion for 10 consecutive days. Acetylsalicylic acid will be given orally, once daily throughout the study duration of 90 days as basic treatment. The clinical observation period for each patient will be 3 months and will include six clinical evaluation visits at Baseline (day 1) and on study days 2, 5, 10, 30 and 90.
| Condition | Intervention | Phase |
|---|---|---|
|
Ischemic Stroke |
Drug: Cerebrolysin Drug: 0.9% Saline Solution |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Cerebrolysin in Patients With Acute Ischemic Stroke |
Further study details as provided by Ever Neuro Pharma GmbH:
Primary Outcome Measures:
- Modified Rankin Scale [ Time Frame: 90 days after start of treatment ] [ Designated as safety issue: No ]
- Barthel Index [ Time Frame: 90 days after start of treatment ] [ Designated as safety issue: No ]
- NIH Stroke Scale [ Time Frame: 90 days after start of treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- SF-12 [ Time Frame: 90 days after start of treatment ] [ Designated as safety issue: No ]
- Overall mortality [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
| Enrollment: | 1071 |
| Study Start Date: | September 2006 |
| Study Completion Date: | February 2011 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Cerebrolysin |
Drug: Cerebrolysin
30 ml study drug will be given once daily by intravenous infusion for 10 consecutive days.
|
| Placebo Comparator: 0.9% Saline Solution |
Drug: 0.9% Saline Solution
30 ml will be given once daily by intravenous infusion for 10 consecutive days.
Other Name: NaCl
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age between 18 and 85 years
- Focal neurological deficit
- Clinical diagnosis of acute hemispheric ischemic stroke
- CT or MRI results compatible with clinical diagnosis of acute hemispheric stroke
- NIH Stroke Scale Score between 6 and 22, both inclusive
- Functionally independent prior to stroke with a pre-stroke Rankin Score of 0 or 1
- Randomization and first treatment with the trial medication within 12h after stroke onset
- Informed consent given by the patient and/or the patient's legally acceptable representative
Exclusion Criteria:
- Evidence on CT/MRI of acute or chronic intracerebral hemorrhage, SAH, AVM, cerebral aneurysm, or neoplasm
- Signs of herniation, increased intracranial pressure or likely etiology other than brain ischemia at baseline CT scan
- Patients with a substantial decrease of consciousness or alertness at the time of randomization, defined as score of 2 or more one of the NIH Stroke Scale questions 1a.
- Neurological signs and symptoms that improve rapidly during screening and are likely to resolve completely within 24h
- Severe coexisting systemic disease that significantly limits life expectancy
- Systolic blood pressure over 220 mmHg or diastolic blood pressure over 120 mmHg on repeated measurement (interval of 30 min) prior to study entry
- Severe congestive heart failure or presentation with acute myocardial infarction at study entry
- Epilepsy or epileptic seizures at onset of stroke
- Pre-existing disorders or conditions that would impair interpretation of neurological assessment (eg. severe dementia, severe psychiatric illnesses, etc).
- Concomitant treatment with other neuroprotective or nootropic drugs (e.g. piracetam, citicoline, investigational neuroprotective substances)
- Patients which cannot tolerate or have contraindication to aspirin or Cerebrolysin treatment
- Concomitant treatment with substances that have a dilative effect on blood vessels like naftidrofuryl, cinnarizine, flunarizine or nimodipine
- Pregnancy and lactation period; for women with child-bearing potential a negative pregnancy test is required
- Participation in a clinical trial with an investigational drug in the past 4 weeks
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00868283
Show 49 Study Locations
Show 49 Study LocationsSponsors and Collaborators
Ever Neuro Pharma GmbH
Excel PharmaStudies, Inc.
idv Datenanalyse und Versuchsplanung
Investigators
| Study Director: | Philipp Novak, PhD | EVER Neuro Pharma |
| Principal Investigator: | Zhen Hong, MD | Huashan Hospital, affiliated Fudan University |
More Information
No publications provided by Ever Neuro Pharma GmbH
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr. Philipp Novak, EVER Neuro Pharma |
| ClinicalTrials.gov Identifier: | NCT00868283 History of Changes |
| Other Study ID Numbers: | EBE-CN-050823 |
| Study First Received: | March 23, 2009 |
| Last Updated: | July 6, 2011 |
| Health Authority: | Korea: Food and Drug Administration |
Additional relevant MeSH terms:
|
Ischemia Stroke Cerebral Infarction Pathologic Processes Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
Brain Infarction Brain Ischemia Cerebrolysin Nootropic Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Neuroprotective Agents Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013