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 | 14.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061256 |
E.1.2 | Term | Ischaemic stroke |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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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 primary objective of the present study is to assess efficacy of AX200 compared to placebo in patients suffering from acute stroke. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to assess safety and tolerability of AX200. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
All of the following inclusion criteria need to be fulfilled: · Diagnosis of acute ischemic stroke with an onset within 9 hours prior to start of study agent administration. · ischemic stroke in the MCA territory confirmed by MRI (diffusion) · men and women aged ≥ 18 years and ≤ 85 years · NIHSS score ≥ 6 and ≤22 · lesion size on DWI: on the slice showing the largest extension of the infarct the largest diameter of the lesion should have at least 3 cm and should show on at least 3 consecutive slices; if the rule cannot be applied (e.g. due to an irregular shape or partially separate volumes on the slice), but in the clinical judgment the lesion is ≥ 15 cm3, the patient should be included in the clinical study if the investigator can provide a written justification · written informed consent |
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E.4 | Principal exclusion criteria |
Patients meeting any of the following criteria will be excluded from randomization: · Participation in another study with an investigational drug or device within the last 30 days or planned participation in another trial · Prior to current stroke: Inability to walk or to lead an independent life or prestroke BI score < 95 or pre-stroke mRS score > 1 · Life expectancy considered to be less or equal 6 months in the judgment of the investigator · Neurological deficit that has led to stupor or coma (suspicious of malignant hemispheric stroke) · Infarct is lacunar · Any evidence of ICH by imaging. Patients with cerebral micro-bleedings can be included in the study. · Current malignant hypertension with systolic and diastolic blood pressure > 220 mmHg and > 120 mmHg, respectively · Strong clinical suspicion of septic embolus · Any thrombosis involving the cerebral veins · High clinical suspicion of vasculitis (e.g. multiple caliber irregularities of intracerebral vessels on MRA plus history of vasculitis) · Any MRI finding indicating that there might be a non-vascular cause for the present neurological symptoms · Any signs on imaging of a mass effect causing shift of midline structures · Presence or history of active malignancies within one year preceding randomization, especially hematological malignancies or myeloproliferative diseases · A platelet count < 100 /nl at V0 · A leukocyte count >20 /nl at V0 · Congenital neutropenia · Other serious illness, e.g., severe hepatic, cardiac, or renal failure, acute myocardial infarction or a complex disease that may confound treatment assessment · Any suspected hypersensitivity and/or contraindication to any ingredients of the study medication · Patients currently receiving G-CSF or GM-CSF · Thrombolytic drug treatment outside the recommendations of the current ESO "Guidelines for Management of Ischemic Stroke and Transient Ischemic Attack 200", especially if the treatment was initiated > 4.5 hours after stroke onset, or the patient had recent severe or dangerous bleeding prior treatment, or despite anticoagulant or heparin treatment · Patients for which any of the following treatments are planned for acute recanalisation of intracranial vessels: use of mechanical devices for clot retraction like the Merci Retriever or the Penumbra System, or any vessel dilation or stenting procedure · Pregnant or lactating women (for women of childbearing potential a negative serum pregnancy test is required at V0) · Patients with a history of active substance abuse (including alcohol) for the last 2 years |
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E.5 End points |
E.5.1 | Primary end point(s) |
Improvement on continuous mRS relative to placebo-treated patients. |
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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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 39 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 83 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
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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The end of the study is defined as database lock, as this is the end of clinical data collection. |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |