E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Drug resistant nocturnal frontal lobe epilepsy |
Epilessia frontale notturna farmacoresistente |
|
E.1.1.1 | Medical condition in easily understood language |
Drug resistant nocturnal frontal lobe epilepsy |
Epilessia frontale notturna farmacoresistente |
|
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 | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10049424 |
E.1.2 | Term | Frontal lobe epilepsy |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
|
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 |
verify the clinical efficacy of adjunctive therapy with fenofibrate in patients with nocturnal frontal lobe epilepsy |
verificare l'efficacia clinica della terapia aggiuntiva con fenofibrato nei pazienti affetti da FNLE farmacoresistente |
|
E.2.2 | Secondary objectives of the trial |
To examine changes in the EEG signal, describe the modulation, the dynamics and the change in density of cortical neuronal nicotinic receptor for acetylcholine (nAChR) through the use of brain SPECT. |
esaminare le modificazioni del segnale EEG;
descrivere la modulazione, la dinamica e la variazione della densità corticale del recettore nicotinico neuronale per l'acetilcolina (nAChR) mediante l'utilizzo della SPECT cerebrale. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients of both sexes aged between 18 and 65 years with nocturnal frontal lobe epilepsy in particular in its autosomal dominant form resistant to conventional therapies
May be included in the study patients concurrently treated with anticoagulants, oral hypoglycemic agents or insulin only if the dosage of these drugs will initially be halved
Women of childbearing age who use contraceptives
Signing the informed consent |
Pazienti di entrambi i sessi di età compresa tra 18 e 65 anni affetti da Epilessia del lobo frontale notturna in particolare nella sua forma autosomica dominante resistenti alle terapie convenzionali
Potranno essere inseriti nello studio pazienti trattati contemporaneamente con anticoagulanti, ipoglicemizzanti orali o insulina solo se il dosaggio di questi farmaci verrà inizialmente dimezzato
Donne in età fertile che fanno uso di contraccettivi
Firma del consenso informato |
|
E.4 | Principal exclusion criteria |
Patients with hepatic, renal, severe peptic ulcer patients.
Patients treated with statins
Subjects with hypersensitivity to the components
Women who are pregnant or breastfeeding |
Pazienti affetti da insufficienza epatica, renale gravi, pazienti affetti da ulcera peptica.
Pazienti in trattamento con statine
Soggetti con ipersensibilità verso i componenti
Donne in stato di gravidanza o in allattamento |
|
E.5 End points |
E.5.1 | Primary end point(s) |
verify the clinical efficacy of adjunctive therapy with fenofibrate in patients with nocturnal frontal lobe epilepsy |
verificare l'efficacia clinica della terapia aggiuntiva con fenofibrato nei pazienti affetti da FNLE farmacoresistente |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
To examine changes in the EEG signal, describe the modulation, the dynamics and the change in density of cortical neuronal nicotinic receptor for acetylcholine (nAChR) through the use of brain SPECT. |
esaminare le modificazioni del segnale EEG;
descrivere la modulazione, la dinamica e la variazione della densità corticale del recettore nicotinico neuronale per l'acetilcolina (nAChR) mediante l'utilizzo della SPECT cerebrale. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |