REACT ON (REscuing ACTivity Of Na-channels) STUDY Study and correction of abnormalities of nonsense mutations in Brugada Syndrome. - REACT-ON

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-020117-87-IT

Enrollment

Registered

2010-05-13

Start date

2010-05-03

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brugada syndrome MedDRA version: 9.1 Level: SOC Classification code 10007541

Interventions

Trade Name: GENTAMICINA SOLFATO Pharmaceutical Form: Solution for injection INN or Proposed INN: Gentamicin Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal Concentration numb

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - Brugada Syndrome - Mutation of the SCN5A gene - Male gender - Age > 18 years and =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Female gender - Age 75 years - Known hypersensitivity to aminoglycoside - Hearing impairment - Renal insufficiency - Current therapy with steroids or creatine - Concomitant use of medications with potential nephrotoxic effect

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of this study is to evaluate the efficacy of gentamicin administration on the electrocardiographic manifestations in affected with Brugada Syndrome and a SCN5A gene mutation.;Secondary Objective: -;Primary end point(s): Primary endpoint is to quantify the regression of electrocardiographic manifestatins of Brugada syndrome (ST segment elevation) during short-term administration of gentamycin.	—

Measure

Time frame

Main Objective: The aim of this study is to evaluate the efficacy of gentamicin administration on the electrocardiographic manifestations in affected with Brugada Syndrome and a SCN5A gene mutation.;Secondary Objective: -;Primary end point(s): Primary endpoint is to quantify the regression of electrocardiographic manifestatins of Brugada syndrome (ST segment elevation) during short-term administration of gentamycin.

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026