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Safety Extension Study of TRO19622 in ALS | Clinical Trials | Clareo Health

COMPLETEDPHASE2/PHASE3

Safety Extension Study of TRO19622 in ALS

An Open-label Safety Extension Study of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) Patients Treated With Riluzole

NCT01285583•Hoffmann-La Roche

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).

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

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.

Locations (15)

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

Key Dates

Start Date

October 1, 2010

Primary Completion Date

March 1, 2012

Completion Date

March 1, 2012

Last Updated

November 22, 2016

Enrollment

271

ACTUAL participants

Conditions

Amyotrophic Lateral Sclerosis

Interventions

TRO19622

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 22, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety Extension Study of TRO19622 in ALS

Inclusion Criteria

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