E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Not possible to specify |
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 is to evaluate the efficacy and safety of lorazepam intravenously administered in subjects with status epilepticus. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective to evaluate pharmacokinetics of lorazepam in Japanese subjects with status epilepticus. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Subjects with status epilepticus or repetitive status epilepticus / cluster seizure who have seizures that can be evaluated by investigator's visual observations based on motor symptoms or who have seizures that can be evaluated by EEG. - Subjects with status epilepticus accompanied by generalized seizure, partial seizure or secondarily generalized seizure lasting 5 minutes or longer - Subjects with repetitive status epilepticus / cluster seizure accompanied by not less than 3 consecutive episodes of generalized seizure, partial seizure or secondarily generalized seizure in 1 hour. - Subjects not younger than 3 months (either gender is eligible for the study)
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E.4 | Principal exclusion criteria |
- Subjects with known or suspected recurrent seizures due to illegal drug or alcohol withdrawal - Subjects with known history of hypersensitivity to lorazepam or benzodiazepine - Subjects with a known history of benzodiazepine abuse. - Subjects currently receiving lorazepam - Subjects with angle-closure glaucoma - Subjects with myasthenia gravis - Subjects with either of aspartate transaminase, alanine transaminase, total bilirubin, blood urea nitrogen, or creatinine at screening visit exceeding 2x the upper limit of normal of the institutional reference value (if the data is available) - Subjects with white blood cell count less than 3000/mm3 or neutrophil count less than 1500/mm3 at screening visit (if the data is available) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Percent of participants whose initial seizure stopped within 10 minutes after initial dose and who continued seizure-free for at least 30 minutes after the completion of initial dose (responder rate) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1. Percent of participants whose initial seizure stopped within 10 minutes after the administration of study drug (either initial or second dose [in 10 to 30 minutes from the initial dose]) and who continued seizure-free for at least 30 minutes. 2. Percent of participants whose seizures stopped within 10 minutes after the administration of study drug (only the initial dose) and who continued seizure-free for at least 12 hours post-dose. 3. Percent of participants whose seizures stopped within 10 minutes after the administration of study drug (either initial or second dose [in 10 to 30 minutes from the initial dose]) and who continued seizure-free for at least 12 hours post-dose. 4. Percent of participants whose seizures stopped within 10 minutes after the administration of study drug (only the initial dose) and who continued seizure-free for at least 24 hours post-dose. 5. Percent of participants whose seizures stopped within 10 minutes after the administration of study drug (either initial or second dose [in 10 to 30 minutes from the initial dose]) and who continued seizure-free for at least 24 hours post-dose. 6. Time to resolution of seizures from the administration of study drug (only the initial dose). 7. Time to resolution of seizures from the administration of study drug (either initial or second dose). 8. Time to relapse from the resolution of seizures following the administration of study drug (only the initial dose, within 24 hours). 9. Time to relapse from the resolution of seizures following the administration of study drug (either initial or second dose, within 24 hours).
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Time Frame: 1 hour 2. Time Frame: 12 hours 3. Time Frame: 12 hours 4. Time Frame: 24 hours 5. Time Frame: 24 hours 6. Time Frame: 24 hours 7. Time Frame: 24 hours 8. Time Frame: 24 hours 9. Time Frame: 24 hours |
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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 | 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) | 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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | No |
E.8.2.3 | Other | No |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA 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.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 22 |
E.8.9.2 | In all countries concerned by the trial days | 0 |