E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10055221 |
E.1.2 | Term | Ischemic stroke |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
- 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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 < 50 (corresponding to the half of the body showing hemiparesis) - a score of >2 in the Goodglass and Kaplan Communication Scale |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 13 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |