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Sponsors and Collaborators: |
Trophos European Commission |
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Information provided by: | Trophos |
ClinicalTrials.gov Identifier: | NCT00868166 |
The purpose of the assay is to assess the safety and the efficacy of TRO19622 330 mg QD as add-on therapy to riluzole 50 mg bid in the treatment of patients suffering from ALS, as compared to placebo, assessed by the 18-month survival rate.
Condition | Intervention | Phase |
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Amyotrophic Lateral Sclerosis |
Drug: Olesoxime Drug: Placebo Comparator |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase II/III, Multicenter, Randomized, Parallel Group, Double-Blind, Placebo Controlled Study to Assess Safety and Efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) Patients Treated With Riluzole |
Estimated Enrollment: | 470 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | April 2011 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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TRO19622: Experimental
2 Capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid
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Drug: Olesoxime
2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzol 50mg bid
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Control: Placebo Comparator
2 Capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid
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Drug: Placebo Comparator
2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid
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A stand alone treatment with TRO19622 is not acceptable for ethical reasons. Riluzole is an approved and widely used ALS treatment in the European community, in Japan and in the USA. Therefore, in this study, TRO19622 will be assessed as add-on to riluzole in patients suffering from ALS.
At the start of the study, patients will be randomized to one of two groups : TRO19622 (330 mg QD or placebo (once a day).
Each treatment will be administered for 18 months under double-blind conditions. The product under evaluation will be administered to patients receiving the standard of care for ALS, including riluzole. Riluzole dosage (50 mg bid) must be stable and well tolerated for at least one month prior to inclusion into the study.
After the double-blind period, open-label administration of TRO19622 will be allowed for safety and survival assessments and until efficacy results are available. A separate open-label protocol will be written 6 months after the randomization of the last patient into the study.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Valérie Cuvier, Clinical Study Manager, BSc | +33 4 91 82 82 99 | vcuvier@trophos.com |
Belgium | |
University Hospital Gasthuisberg - Dept Neurology | |
Leuven, Belgium, 3000 | |
France | |
Groupe Hospitalier PITIE-SALPETRIERE - Fédération des Maladies du Système Nerveux | |
Paris, France, 75013 | |
Hôpital La Timone - Service Neurologie et Maladies Neuromusculaires | |
Marseille, France, 13005 | |
CHRU de LILLE - Hôpital Roger Salengro - Centre SLA-MMN - Sce de Neurologie et Pathologie du Mouvement | |
Lille, France, 59037 | |
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 | |
Centre SLA Limoges - Service de Neurologie | |
Limoges, France, 87042 | |
Germany | |
Universitäts- und Rehabilitationskliniken Ulm (RKU) - Neurologische Universitätsklinik | |
Ulm, Germany, 89081 | |
Neurologische Klinik Medizinische Hochschule | |
Hannover, Germany, D-30623 | |
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 | |
Netherlands | |
University Medical Center Utrecht - Department of Neurololy, G.03.228 | |
Utrecht, Netherlands, 3508 | |
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 |
Principal Investigator: | Vincent Meininger, MD, PhD | Groupe Hospitalier Pitie-Salpetriere |
Responsible Party: | TROPHOS ( Jean Louis ABITBOL ) |
Study ID Numbers: | TRO19622 CL E Q 1015-1, EudraCT Number:2008-007320-25 |
Study First Received: | March 23, 2009 |
Last Updated: | March 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00868166 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Belgium: Federal Agency for Medicinal Products and Health Products; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Amyotrophic Lateral Sclerosis TRO19622 Trophos |
Riluzole Excitatory Amino Acids Neurotransmitter Agents Spinal Cord Diseases Central Nervous System Diseases Sclerosis Neurodegenerative Diseases |
Neuroprotective Agents Neuromuscular Diseases Lou Gehrig's Disease Amyotrophic Lateral Sclerosis Motor Neuron Disease Degenerative Motor System Disease Anticonvulsants |
Riluzole Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Spinal Cord Diseases Physiological Effects of Drugs Nervous System Diseases Central Nervous System Diseases Sclerosis Excitatory Amino Acid Agents Neurodegenerative Diseases Protective Agents |
Neuroprotective Agents Pharmacologic Actions Pathologic Processes Neuromuscular Diseases Amyotrophic Lateral Sclerosis Therapeutic Uses Central Nervous System Agents Motor Neuron Disease Anticonvulsants Excitatory Amino Acid Antagonists |