E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Partial Onset Epilepsy Seizures |
|
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 |
Percent reduction in seizure frequency (average monthly seizure rate per 28 days) of all simple partial motor and/or complex partial, and/or secondarily generalized seizures during the double-blind treatment phase, relative to the pre-treatment phase. |
|
E.2.2 | Secondary objectives of the trial |
- Proportion of subjects with > 50% reduction from the pre-treatment baseline phase in seizure frequency. - Change relative to baseline in the Recovery (after seizures) composite score of the SSQ compared to the end of the double-blind treatment phase. - Changes in overall and subscale scores of various outcome scales. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female aged 16 years or older, inclusive. 2. Weight of at least 35 kg. 3. Established diagnosis of partial epilepsy for at least 1 year, using ILAE criteria. 4. History of inadequate response to at least 1 AED. 5. Current treatment with at least 1 and no more than 2 AED's. 6. Have had at least 3 simple partial motor, complex partial, or secondarily generalized seizures per month, and no seizure-free interval for more than 3 weeks. 6. Post-menopausal females, or those using acceptable method of birth control.
|
|
E.4 | Principal exclusion criteria |
1. History of status epilepticus within 6 months before study entry. 2. Generalized epileptic syndrome or having only absence, atonic/tonic, or simple partial sensory or other simple partial type seizures. 3. Lennox-Gastaut Syndrome 4. Current serious or medically unstable systemic diseases. 5. Current major depression, or history of suicide within last 2 years. 6. History of drug or alcohol abuse. 7. Positive for hepatitis B or C, or HIV/AIDS. 8. History of drug-induced liver injury, or diagnosis of any form of chronic liver disease. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change in frequency of partial onset seizures during the pre-treatment baseline phase and during the double-blind treatment phase. Subject diaries will be the source of all seizure data. |
|
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 | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
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) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Double-blind followed by open label phase |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 9 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 27 |
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 |
|
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
| |
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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |