E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Adult patients with a cardiac sodium channel gene SCN5A mutation, one variant of the congenital long-QT syndrome, with implantable cardioverter defibrillator (ICD). |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10057926 |
E.1.2 | Term | Long QT syndrome congenital |
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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 assess the effect of Omacor on the electrocardiographic QTc Fridericia interval in LQT3 patients (cardiac sodium channel gene SCN5A mutation leading to congenital long-QT syndrome). |
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E.2.2 | Secondary objectives of the trial |
To assess the effect of Omacor® on: - the T wave morphology, - the standard ECG parameters: RR interval, QRS complex, PR interval, - the relationship between the QTc Fridericia interval and the erythrocyte cellular membrane and cheek cells concentration in PUFAs.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Male or female gender, • Aged from 18 to 60 years, • LQT3 syndrome genotype confirmed in medical file, • QTc interval more or equal to 470 ms, • Wearing an ICD, • Accepting to participate to the study and able to understand and sign an approved Informed Consent Form, • Able to understand the protocol and to come to the control visits, • Likely to be compliant during the study, according to the judgement of the investigator, • Registered with a social security or health insurance system.
For women of child bearing potential: • Use of an efficient contraceptive for at least 2 months before the study and one month after the end of the study, • Negative urine or blood pregnancy test.
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E.4 | Principal exclusion criteria |
* Criteria related to pathologies • History of hypersensitivity or intolerance to one of the substances of content of the study drug (EPA ethyl ester, DHA ethyl ester, alpha-tocopherol, gelatin, soya), • Severe hepatic impairment, • High risk of haemorrhage, • Any cardio-vascular, renal, gastro-intestinal, endocrine, haematological, neuro-psychiatric disease that will not be compatible with the participation to the study in the opinion of the investigator, • Any acute or chronic disease that will not allow with the participation to the study in the opinion of the investigator.
* Criteria related to treatments • Use of any medication that prolongs QT interval. The list of the Drugs to be Avoided by Patients with Congenital Long QT Syndrome is detailed on web site: www.QTdrugs.org (see appendix 17.2) • Use of food complements enriched in n-3 PUFAs in the last 2 weeks.
* Criteria related to the way of life Consumption of n-3 PUFAs rich foods (fat fishes, soya, colza and nut oils) > 3 times/week.
* Criteria related to the population • Participation to another clinical study in the previous month or during the study or planning to participate to another clinical study within one month after the present study, • Forfeited freedom by administrative or legal award, or under guardianship, • Who cannot be contacted in case of emergency, • Who planned travel outside the study area for a substantial portion of the study period.
For women of childbearing potential: • Pregnancy, • Breast-feeding. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The main criterion is defined as the modification of the QT interval corrected for heart rate (QTc) using the Fridericia equation after 6 weeks of treatment. |
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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 | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
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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.8.3 |
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 | Information not present in EudraCT |
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.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |