E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute intracerebral hemorrhage not caused by trauma or tumor or being secondary to acute ischemic stroke, i.e hemorrhagic transformation. |
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MedDRA Classification |
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 this study is to assess the safety and tolerability of NXY-059 compared to placebo in patients with acute ICH by assessment of mortality (overall and by cause), the incidence of serious adverse events, the incidence of adverse events, change from baseline in the laboratory parameters, change from baseline in vital signs, incidence of abnormalities and change from baseline in ECG parameters, and change from baseline in neuroimaging scans. |
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E.2.2 | Secondary objectives of the trial |
To explore the efficacy of NXY-059 compared to placebo in patients with acute ICH by evaluating the recovery with respect to global disability, neurological recovery, functional recovery and patient reported disability To investigate the pharmacokinetics of NXY-059 in patients with acute ICH.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Males and females ≥18 years of age. A clinical diagnosis of acute stroke with limb weakness as part of the presenting deficit(s) and a neuroimaging scan (CT or MRI) showing an ICH. Onset of symptoms within 6 hours of the planned start of investigational product infusion. Onset time for patients who awake with symptoms is defined as the last time the patient was awake without symptoms of stroke.
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E.4 | Principal exclusion criteria |
Evidence from neuroimaging (CT or MRI scan) or other pre?randomization investigations of another cause of the symptom than ICH Unconsciousness (ie, 3 on item 1a. on the NIHSS score). Severe concurrent illness with life expectancy less than 6 months. Known severe renal disorder from the patient's history. Patients with a known calculated creatinine clearance of <30 mL/min using the Jaffe method or <35mL/min using the modified Jaffe or enzymatic method to determine S-Creatinine should be excluded. Pregnancy or breast-feeding. Women must be either post-menopausal (judged by the investigator), permanently sterilized or, if of childbearing potential must have a negative test for pregnancy obtained before randomization and use appropriate contraception at least 3 weeks before randomization until 7 days after last dose of investigational product. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety Since the assessment of safety and tolerability requires multiple measures, there is no single primary variable selected. Primary outcome variables: - Mortality (overall and by cause) - Incidence of adverse events, serious and non-serious - Change from baseline in laboratory parameters (clinical chemistry, hematology and urine) - Change from baseline in vital signs - Incidence of abnormalities and change from baseline in ECG parameters - Change from baseline in CT/MRI scans.
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
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 | No |
E.8.5 | The trial involves multiple Member States | Yes |
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 | Information not present in EudraCT |
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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Data base locked Rational: The timepoint after which no subjects will be exposed to study related activities |
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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 | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
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 | 1 |