An Open Label Safety Extension Study of olesoxime (TRO19622) in Amyotrophic Lateral SclerosisUn extensión del estudio en abierto de la seguridad del TRO19622 en Esclerosis Lateral Amiotrófica (ELA)de los pacientes tratados con riluzol.

• Conditions: Amyotrophic Lateral SclerosisEsclerosis Lateral Amiotrófica; MedDRA version: 13Level: LLTClassification code 10002026Term: Esclerosis lateral amiotrófica

• Registration Number: EUCTR2010-021179-10-ES
• Lead Sponsor: TROPHOS SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03-02
• Last Update Posted: 3 September 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients must have completed the 18month
safety and efficacy study of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole (Protocol TRO19622 CL E Q 10151).
Both the investigator and the patient will decide based on previous good tolerance and other clinical grounds whether or not to participate to the openlabel extension. If patients were on antivitamin K during the doubleblind period, when entering the openlabel extension, coagulation
tests should be monitored in exactly the same conditions as if a new anticoagulant treatment was initiated and the dose of antivitamin K should be adjusted accordingly(see secti on 8.3.11).
Patients enrolling from this prior safety and efficacy study must:
If female of childbearing age of potential, continue to use adequate birth control methods and have a negative serum pregnancy test at the preceding doubleblind protocol termination visit. Male and female partners must agree to use an
effective method of birth control during their participation in the trial and for at least 15 days after the last IMP dose. Both partners must use reliable methods of contraception with 2 independent methods. The following measures are acceptable: Hormone contraceptives (e.g. oral contraceptives or comparable methods), intrauterine device, condoms with spermicidal coating or in combination with spermicidal creams, total abstinence or sterilisation performed in the
past. Be able to follow the investigators instructions and be able to comply with the visit schedule and visit requirements;and Sign a written informed consent.
· Los pacientes deben haber completado los 18 meses del estudio de eficacia y seguridad
de TRO19622 en pacientes con esclerosis lateral amiotrófica (ELA) en tratamiento con
riluzola (Protocolo TRO19622 CL E Q 1015-1).
· El investigador y el paciente decidirán, basándose en la buena tolerancia previa y en
otros fundamentos clínicos, su participación o no en el estudio de extensión abierto.
· Si los pacientes estaban en tratamiento antivitamina K durante el periodo doble ciego,
al entrar en la extensión abierta se deben supervisar las pruebas de coagulación
exactamente en las mismas condiciones que si se iniciara un nuevo tratamiento
anticoagulante, ajustándose la dosis de vitamina K en consecuencia (véase sección
8.3.11).
· Los pacientes incluidos procedentes de este estudio previo de seguridad y eficacia
deben:
Si se trata de una mujer en edad fértil, continuar usando métodos adecuados de
control de la natalidad y tener una prueba sérica de embarazo negativa en la visita
de finalización del protocolo doble ciego,
Ser capaces de seguir las instrucciones del investigador y poder cumplir el
calendario de visitas y las exigencias de las visitas; y Firmar un consentimiento informado.
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients may not participate to this study if they have an ongoing, unresolved, clinically significant medical problem (including patients having serious adverse events or nonserious,
but medically significant adverse events during the preceding safety and efficacy study that was assessed to be related to the study medication by the investigator)that is on the judgment of the investigator would make it unsafe for the patient to participate in the trial.
Los pacientes no pueden participar en este estudio si tienen un problema médico actual, no
resuelto, clínicamente importante (incluidos los pacientes que han experimentado
acontecimientos adversos graves o no graves, aunque médicamente significativos, durante el
estudio precedente de seguridad y eficacia que el investigador juzgara relacionado con el
medicamento del estudio) que, a criterio del investigador, hiciera arriesgada la participación
del paciente en el ensayo.

Study & Design

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