EUCTR2010-021179-10-ES进行中（未招募）不适用
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.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- TROPHOS SA
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •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
排除标准
- •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.
研究者
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