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Safety Extension Study of TRO19622 in ALS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01285583
Recruitment Status : Completed
First Posted : January 28, 2011
Last Update Posted : November 22, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Drug: TRO19622 Phase 2 Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 271 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: An Open-label Safety Extension Study of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) Patients Treated With Riluzole
Study Start Date : October 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

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

Primary Outcome Measures :
  1. The primary outcome measure will be the safety assessment. [ Time Frame: Safety assessment will be calculated from the date of enrollment for a maximum of 15 months. ]

    safety criteria will be:

    • Occurrence of AEs,
    • Physical examination,
    • Laboratory tests,
    • Vital signs and ECG,

Secondary Outcome Measures :
  1. Secondary Outcome Measures [ Time Frame: Every 3 month, from the date of enrollment for a maximum of 15 months. ]

    Secondary Outcome Measures will be:

    • Survival time
    • Total score of the 48-point ALS Functional Rating Scale Revised
    • Slow Vital capacity (SVC) as a percentage of predicted SVC only if the SVC is performed by the site in a routine-way during standard ALS visit. This test will not be performed for the sole purpose of the study

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01285583

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University Hospital Gasthuisberg - Dept Neurology - Herestraat 49
Leuven, Belgium, 3000
HCL Hôpital Neurologique et Neurochirurgical Pierre Wertheimer - Neurologie C et Laboratoire d'électromyographie - 59, boulevard Pinel
Bron Cedex, France, 69677
CHRU de LILLE - Hôpital Roger Salengro - Centre SLA-MMN - Sce de Neurologie et Pathologie du Mouvement
Lille, France, 59037
Centre SLA Limoges - Service de Neurologie
Limoges, France, 87042
Hôpital La Timone - Service Neurologie et Maladies Neuromusculaires
Marseille, France, 13005
Clinique du Motoneurone - Sce d'Explorations Neurologiques - Hôpital Gui de Chauliac
Montpellier, France, 34295
CHU de Nice - Hôpital de l'Archet 1 - Centre de Référence pour les Maladies Neuromusculaires et la SLA
Nice, France, 06202
Groupe Hospitalier PITIE-SALPETRIERE - Fédération des Maladies du Système Nerveux
Paris, France, 75013
Charité Universitätsmedizin Berlin, Campus Virchow-Klinikum, Neurologische Poliklinik Ambulanz für ALS und andere Motoeneuronenerkrankungen
Berlin, Germany, 13353
Universitätsklinik und Poliklinik für Neurologie - Martin-Luther-Universität Halle-Wittenberg
Halle, Germany, 06097
Neurologische Klinik Medizinische Hochschule
Hannover, Germany, D-30623
Universitäts- und Rehabilitationskliniken Ulm (RKU) - Neurologische Universitätsklinik
Ulm, Germany, 89081
Hospital Carlos III - Unidad de ELA - Sinesio Delgado, 10
Madrid, Spain, 28029
United Kingdom
King's MND Care and Research Center - Academic Neurosciences Building PO Box 41 Institute of Psychiatry
London, United Kingdom, SE58AF
Academic Neurology Unit - University of Sheffield - Section of Neuroscience - Division of Genomic Medicine - School of Medicine and Biomedical Sciences
Sheffield, United Kingdom, S10 2RX
Sponsors and Collaborators
Hoffmann-La Roche
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Principal Investigator: Vincent Meininger, MD, PhD Groupe Hospitalier Pitie-Salpetriere

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Responsible Party: Hoffmann-La Roche Identifier: NCT01285583    
Other Study ID Numbers: WN29852
TRO19622 CL E Q 1425-1 ( Other Identifier: trophos id )
First Posted: January 28, 2011    Key Record Dates
Last Update Posted: November 22, 2016
Last Verified: November 2016
Keywords provided by Hoffmann-La Roche:
Amyotrophoc Lateral Sclerosis
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents