Clinical trial NCT01285583: Safety Extension Study of TRO19622 in ALS
Official title: An Open-label Safety Extension Study of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) Patients Treated With Riluzole
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Amyotrophoc Lateral Sclerosis
TRO19622
Olesoxime
Trophos
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-01-28
Enrollment: 271
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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).

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.

Primary outcomes:
measure: The primary outcome measure will be the safety assessment.
timeFrame: Safety assessment will be calculated from the date of enrollment for a maximum of 15 months.
Secondary outcomes:
measure: Secondary Outcome Measures
timeFrame: Every 3 month, from the date of enrollment for a maximum of 15 months.
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital Gasthuisberg - Dept Neurology - Herestraat 49
city: Bron Cedex
country: France
facility: HCL Hôpital Neurologique et Neurochirurgical Pierre Wertheimer - Neurologie C et Laboratoire d'électromyographie - 59, boulevard Pinel
city: Lille
country: France
facility: CHRU de LILLE - Hôpital Roger Salengro - Centre SLA-MMN - Sce de Neurologie et Pathologie du Mouvement
city: Limoges
country: France
facility: Centre SLA Limoges - Service de Neurologie
city: Marseille
country: France
facility: Hôpital La Timone - Service Neurologie et Maladies Neuromusculaires
city: Montpellier
country: France
facility: Clinique du Motoneurone - Sce d'Explorations Neurologiques - Hôpital Gui de Chauliac
city: Nice
country: France
facility: CHU de Nice - Hôpital de l'Archet 1 - Centre de Référence pour les Maladies Neuromusculaires et la SLA
city: Paris
country: France
facility: Groupe Hospitalier PITIE-SALPETRIERE - Fédération des Maladies du Système Nerveux
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin, Campus Virchow-Klinikum, Neurologische Poliklinik Ambulanz für ALS und andere Motoeneuronenerkrankungen
city: Halle
country: Germany
facility: Universitätsklinik und Poliklinik für Neurologie - Martin-Luther-Universität Halle-Wittenberg
city: Hannover
country: Germany
facility: Neurologische Klinik Medizinische Hochschule
city: Ulm
country: Germany
facility: Universitäts- und Rehabilitationskliniken Ulm (RKU) - Neurologische Universitätsklinik
city: Madrid
country: Spain
facility: Hospital Carlos III - Unidad de ELA - Sinesio Delgado, 10
city: London
country: United Kingdom
facility: King's MND Care and Research Center - Academic Neurosciences Building PO Box 41 Institute of Psychiatry
city: Sheffield
country: United Kingdom
facility: Academic Neurology Unit - University of Sheffield - Section of Neuroscience - Division of Genomic Medicine - School of Medicine and Biomedical Sciences
Study officials:
affiliation: Groupe Hospitalier Pitie-Salpetriere
name: Vincent Meininger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: