E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Partial-onset seizure and primary generalized tonic-clonic seizure |
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E.1.1.1 | Medical condition in easily understood language |
Epilepsy: Fits that affect one part of your brain called a "partial seizure" and fits that affect entire body called as primary generalized tonic-clonic seizure. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10015037 |
E.1.2 | Term | Epilepsy |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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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 |
To observe the following items regarding the safety profile of Fycompa film-coated tablets and oral suspension in normal clinical practice setting: (1) Serious adverse event / adverse drug reaction profile; (2) Unexpected adverse event / adverse drug reaction profile; (3) Already known adverse drug reaction profile; (4) Non-serious adverse event profile; (5) Other information related to the product’s safety and effectiveness |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects who meet the following criteria will be eligible for inclusion in the study: (1) Subjects with approved indication for Fycompa in Korea as follows; 1.Monotherapy 4 years and older - Partial-onset seizures: therapy for treatment of partial-onset seizures with or without secondarily generalized seizures in subjects with epilepsy 2. Adjunctive therapy 4 years and older - Partial-onset seizures: therapy for treatment of partial-onset seizures with or without secondarily generalized seizures in subjects with epilepsy 7 years and older - Primary generalized tonic-clonic seizures: therapy for treatment of primary generalized tonic-clonic seizures in subjects with idiopathic generalized epilepsy (2) Subjects who have written consent for use of personal and medical information for the study purpose |
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E.4 | Principal exclusion criteria |
Exclusion Criteria Subjects who meet the following criteria will be excluded for inclusion in the study. (1) Hypersensitivity to the active substance or to any of the excipients of this medicine (2) In case of Fycompa film-coated tablets, Fycompa contains lactose, therefore subjects with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. In case of Fycompa oral suspension, Fycompa contains sorbitol, therefore subjects with rare hereditary problems of fructose intolerance should not take this medicine. (3) Other subjects judged to be inadequate to participate in the study by doctor |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Number of Subjects With Adverse Events 2. Number of Subjects With Adverse Drug Reactions 3. Number of Subjects With Unexpected Adverse Events 4. Number of Subjects With 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. Percentage of Subjects With Effective Outcome as Measured by Investigator's Clinical Global Impression of Change (CGI-C) Scores |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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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Last visit of the last subject (LVLS) |
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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 | 4 |
E.8.9.2 | In all countries concerned by the trial months | 11 |
E.8.9.2 | In all countries concerned by the trial days | 5 |