E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
Lennox-Gastaut Syndrome
Childhood-Onset Epilepsy |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate the safety of long term administration of E2080 in the participants with Lennox-Gastaut syndrome (LSG) who completed the E2080-J081-304 study. |
|
E.2.2 | Secondary objectives of the trial |
To evaluated the long term efficacy of rufinamide under the open-label treatment in participants with LGS who completed the E2080-J081-304 study. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Participants who have completed the evaluation of Week 12 of the E2080-J081-304 study.
2. Male participants with reproductive ability and female participants with child-bearing potential, or their partners, had to be able to take medically appropriate contraceptive measures.
3. Participants who have provided a written informed consent to participate in this clinical trial until the evaluation of week 12 of the E2080-J081-304 study.
4. Participants who had a family member or a caregiver capable of recording the reporting diary, providing participant information necessary for the study, assisting treatment compliance, and accompanying the participant on scheduled visit days during the study period. |
|
E.4 | Principal exclusion criteria |
1. Participants who were judged by the investigator that they are unfit to participate in this clinical study for safety reasons based on the information up to the evaluation of week 12 of the E2080-J081-304 Study.
2. Participants who were judged by the investigator that they are likely to become non-compliant with administration during the clinical trial period.
3. Participants who were judged by the investigator that they were unfit to participate in this clinical trial.
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of participants with treatment emergent adverse events and serious adverse events |
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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 change in tonic-atonic seizure frequency per 28 days relative to Baseline Phase
2. Percentage change in total seizure frequency per 28 days by visit relative to the Baseline Phase
3. Percentage change in the frequency of seizures other than tonic-atonic seizures, per 28 days by visit relative to the Baseline Phase
4. 25%, 50%, 75%, 100% responder and aggravated subjects in tonic-atonic seizure frequency per 28 days by visit relative to the Baseline Phase |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline, Week 12, Week 24, Week 32, Week 40, Week 52, and Week 52 last observation carried forward (LOCF) |
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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) | 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 | Yes |
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.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 2 |
E.8.9.2 | In all countries concerned by the trial months | 9 |