Effects of OMACOR in patients with a cardiac sodium channel gene SCN5A mutation, one variant of the congenital long-QT syndrome. A proof of concept study.

Phase 1

• Conditions: Adult patients with a cardiac sodium channel gene SCN5A mutation, one variant of the congenital long-QT syndrome, with implantable cardioverter defibrillator (ICD).; MedDRA version: 9.1Level: LLTClassification code 10057926Term: Long QT syndrome congenital

• Registration Number: EUCTR2009-011819-20-FR
• Lead Sponsor: Pierre Fabre Médicament

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-04-15
• Study Completion: 2010-05-25
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 6

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified