E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 demonstrate the efficacy of NXY-059 compared to placebo in subjects with acute ischemic stroke. |
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E.2.2 | Secondary objectives of the trial |
To explore the efficacy of NXY-059 compared to placebo on global disability, functional recovery and neurological status.
To evaluate the effects of NXY-059 in comparison to placebo on the ability of the subjects to perform activities of daily living (ADLs), mobility and hand function and the domain scores for communication, memory and thinking, emotional function and social participation
To evaluate the effects of NXY-059 in comparison to placebo on subjects self-reported health status and health-related quality of life.
To evaluate the safety and tolerability of NXY-059
To characterize the pharmacokinetics of NXY-059
To evaluate the effects of NXY-059 compared to placebo on healthcare resource utilization
To evaluate the effects of NXY-059 compared to placebo on the place of residence, location of care and work status during the 90 day follow-up period after treatment. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Provision of written informed consent.
Males and females ≥18 years of age.
A clinical diagnosis of acute ischemic stroke with limb weakness as part of the presenting deficit(s).
Onset of symptoms within 6 hours of the start of investigational product infusion. Onset time for subjects who awake with symptoms is defined as the last time the subject was awake without symptoms of stroke.
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E.4 | Principal exclusion criteria |
Evidence from neuroimaging studying (CT or MRI scan) or other pre-randomization investigations of an acute intracranial hemorrhage, a tumor, encephalitis or any diagnosis other than acute ischemic stroke (onset within 6 hours) likely to cause the present symptoms.
Unnconsciousness
Severe concurrent illness with life expectancy less than 6 months.
Known severe renal disorder from the subject's history. Subjects with a known calculated creatinine clearance of <30 mL/min 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) |
Primary efficacy outcome variable of the study is the modified Rankin Scale (mRS) at last rating. The co-primary efficacy outcome variable is total National Institute of Health Stroke Scale (NIHSS) score at the last rating. |
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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 | 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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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.8.5 | 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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 16 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 7 |