Safety Extension Study of TRO19622 in ALS

NCT ID: NCT01285583

Last Updated: 2016-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 271 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-03-31

Brief Summary

The purpose of the assay is to assess the safety of TRO19622 330 mg QD as add-on therapy to riluzole 50 mg bid in the treatment of patients suffering from ALS, after completion of the preceding clinical trial (TRO19622 CL E Q 1015-1) in an open label extension.

Detailed Description

Entry of a patient into this safety study is intended to occur immediately after the patient has finished participating in the preceding efficacy study (Protocol TRO19622 CL E Q 1015-1).

The Investigator will explain to the patients the nature of this open-label safety study, its procedures, requirements and restrictions so as to obtain their written informed consent.

Each patient will be treated with olesoxime (TRO19622) until the results of the double-blind trial become available with a maximum of 15 months.

Follow-up visits will take place every 3 months (+/- 2 weeks).

Safety assessments will be performed at all visits (every 3 months).

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Amyotrophoc Lateral Sclerosis; TRO19622; Olesoxime; Trophos

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Olesoxime

All patients will receive the IMP as add-on to riluzole 50 mg bid orally, 50 mg morning and evening on an empty stomach ie at least 20 min before the meal.

Group Type: OTHER

TRO19622

Intervention Type: DRUG

2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzol 50mg bid

Interventions

TRO19622

2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzol 50mg bid

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients must have completed the 18-month safety and efficacy study of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole (Protocol TRO19622 CL E Q 1015-1).
• Both the investigator and the patient will decide based on previous good tolerance and other clinical grounds whether or not to participate to the open-label extension.
• If patients were on anti-vitamin K during the double-blind period, when entering the open-label extension, coagulation tests should be monitored in exactly the same conditions as if a new anticoagulant treatment was initiated and the dose of anti-vitamin K should be adjusted accordingly.
• 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 double-blind 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 investigator's instructions and be able to comply with the visit schedule and visit requirements; and
• Sign a written informed consent.

Exclusion Criteria

Patients may not participate in this study if they have an ongoing, unresolved, clinically significant medical problem (including patients having experienced serious adverse events or non-serious, 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 in the judgment of the investigator would make it unsafe for the patient to participate in the trial.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vincent Meininger, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Groupe Hospitalier Pitie-Salpetriere

Locations

University Hospital Gasthuisberg - Dept Neurology - Herestraat 49

Leuven, , Belgium

HCL Hôpital Neurologique et Neurochirurgical Pierre Wertheimer - Neurologie C et Laboratoire d'électromyographie - 59, boulevard Pinel

Bron, , France

CHRU de LILLE - Hôpital Roger Salengro - Centre SLA-MMN - Sce de Neurologie et Pathologie du Mouvement

Lille, , France

Centre SLA Limoges - Service de Neurologie

Limoges, , France

Hôpital La Timone - Service Neurologie et Maladies Neuromusculaires

Marseille, , France

Clinique du Motoneurone - Sce d'Explorations Neurologiques - Hôpital Gui de Chauliac

Montpellier, , France

CHU de Nice - Hôpital de l'Archet 1 - Centre de Référence pour les Maladies Neuromusculaires et la SLA

Nice, , France

Groupe Hospitalier PITIE-SALPETRIERE - Fédération des Maladies du Système Nerveux

Paris, , France

Charité Universitätsmedizin Berlin, Campus Virchow-Klinikum, Neurologische Poliklinik Ambulanz für ALS und andere Motoeneuronenerkrankungen

Berlin, , Germany

Universitätsklinik und Poliklinik für Neurologie - Martin-Luther-Universität Halle-Wittenberg

Halle, , Germany

Neurologische Klinik Medizinische Hochschule

Hanover, , Germany

Universitäts- und Rehabilitationskliniken Ulm (RKU) - Neurologische Universitätsklinik

Ulm, , Germany

Hospital Carlos III - Unidad de ELA - Sinesio Delgado, 10

Madrid, , Spain

King's MND Care and Research Center - Academic Neurosciences Building PO Box 41 Institute of Psychiatry

London, , United Kingdom

Academic Neurology Unit - University of Sheffield - Section of Neuroscience - Division of Genomic Medicine - School of Medicine and Biomedical Sciences

Sheffield, , United Kingdom

Countries

Belgium; France; Germany; Spain; United Kingdom

Other Identifiers

TRO19622 CL E Q 1425-1

Identifier Type: OTHER

Identifier Source: secondary_id

WN29852

Identifier Type: -

Identifier Source: org_study_id