Safety Extension Study of TRO19622 in ALS

NCT01285583 | Completed Phase 2 DMC

• 2 other identifiers: WN29852TRO19622 CL E Q 1425-1
• Study Type: interventional
• Target: 271
• Locations: 5 countries
• Sites: 15

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.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Amyotrophoc Lateral Sclerosis; TRO19622; Olesoxime; Trophos

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure will be the safety assessment.

  safety criteria will be: * Occurrence of AEs, * Physical examination, * Laboratory tests, * Vital signs and ECG,

  Safety assessment will be calculated from the date of enrollment for a maximum of 15 months.

Secondary Outcomes (1)

• Secondary Outcome Measures

  Every 3 month, from the date of enrollment for a maximum of 15 months.

Study Arms (1)

Olesoxime

OTHER

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.

Drug: TRO19622

Interventions

TRO19622 DRUG

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

Olesoxime

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (15)

University Hospital Gasthuisberg - Dept Neurology - Herestraat 49

Leuven, 3000, Belgium

Location

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

Bron, 69677, France

Location

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

Lille, 59037, France

Location

Centre SLA Limoges - Service de Neurologie

Limoges, 87042, France

Location

Hôpital La Timone - Service Neurologie et Maladies Neuromusculaires

Marseille, 13005, France

Location

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

Montpellier, 34295, France

Location

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

Nice, 06202, France

Location

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

Paris, 75013, France

Location

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

Berlin, 13353, Germany

Location

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

Halle, 06097, Germany

Location

Neurologische Klinik Medizinische Hochschule

Hanover, D-30623, Germany

Location

Universitäts- und Rehabilitationskliniken Ulm (RKU) - Neurologische Universitätsklinik

Ulm, 89081, Germany

Location

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

Madrid, 28029, Spain

Location

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

London, SE58AF, United Kingdom

Location

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

Sheffield, S10 2RX, United Kingdom

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

olesoxime

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Vincent Meininger, MD, PhD

  Groupe Hospitalier Pitie-Salpetriere

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2011
• First Posted: January 28, 2011
• Study Start: October 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: November 22, 2016

Record last verified: 2016-11

Locations

FR (7); GB (2); BE (1); DE (4); ES (1)