Recovery after Stroke MedDRA version: 12.0 Level: LLT Classification code 10055221 Term: Ischemic stroke
Conditions
Interventions
Trade Name: Cerebrolysin ®
Pharmaceutical Form: Solution for infusion
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 215.2-
Pharmaceutical form of th
Sponsors
EVER Neuro Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - stroke onset 24-72 hours prior to first infusion of study drug - stroke is ischemic in origin, supratentorial, radiologically confirmed (CT or MRI) and has volume > 4 cc - age between 18-80 years inclusive - no significant pre-stroke disability (pre-stroke Modified Rankin Score of 0 or 1) - no other stroke in 3 months preceding index stroke - Action Research Arm Test Score 2 in the Goodglass and Kaplan Communication Scale Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - progresive or unstable stroke - pre-existing and active major neurological disease - pre-existing and active (e.g. on chronic medication) major psychiatric disease, such as major depression, schizophrenia, bipolar disease or dementia - a history of significant alcohol or drug abuse in the prior 3 years - advanced liver, kidney, cardiac or pulmonary disease - a terminal medical diagnosis consistent with survival < 1 year - substantial decrease in alertness at time of randomization, defined as score of 2 on NIH stroke scale question 1a, 1b or 1c - pregnancy or lactating; note that a negative pregnancy test will be required if the patient is female in reproductive years - any condition that would represent a contraindication to Cerebrolysin, including allergy to Cerebrolysin - current enrolment in another therapeutic study of stroke or stroke recovery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: - to test the hypothesis that Cerebrolysin, as compared to placebo, will show improved scores at 90 days poststroke on tests of gait velocity, fine motor function, global neurological status, disability, neglect, quality of life and depression. - to evaluate the safety - to determine which demopraphic, clinical, and radiological characterisitics predict response to treatment with Cerebrolysin. - to evaluate the primary and secondary endpoints on day 23 i.e. on the last day of Cerebrolysin treatment;Main Objective: The aim of this trial is to test the hypothesis that patients randomized to Cerebrolysin show improved ARAT scores over the 90 days of study participation as compared to patients randomized to placebo.;Primary end point(s): Action Research Arm Test (ARAT) scored 0-57 points, with higher scores beeing better, and normal score value beeing 57, tests arm motor function. The ARAT has been used in a number of trials and has been found to have good construct validity, reliability and predictive value. This scale is responsive to spontaneous and treatmentinduced motor gains in patients with stroke, more then is the case with the Fugl-Meyer motor scale (Hsueh and Hsieh, 2002, Hsieh, 1998, de Weerdt, 1985, van der Lee, 2001, Wagenaar et al, 1990, Dromerick et al, 2000, Kwakkel et al, 1999, Page et al, 2005, Powell et al, 1999, Lyle et al, 1981, Broeks et al, 1999, Parry et al, 1999). The endpoint efficacy assessment will be performed within 3 days of the 90th day post-stroke onset. | — |
Countries
Poland
Outcome results
None listed