Safety Extension Study of TRO19622 in ALS

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01285583
• Other study ID #: WN29852
• Secondary ID: TRO19622 CL E Q
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 26, 2011
• Last updated: November 21, 2016
• Start date: October 2010
• Est. completion date: March 2012

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 271
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
Belgium	University Hospital Gasthuisberg - Dept Neurology - Herestraat 49	Leuven
France	HCL Hôpital Neurologique et Neurochirurgical Pierre Wertheimer - Neurologie C et Laboratoire d'électromyographie - 59, boulevard Pinel	Bron Cedex
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
Germany	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	Neurologische Klinik Medizinische Hochschule	Hannover
Germany	Universitäts- und Rehabilitationskliniken Ulm (RKU) - Neurologische Universitätsklinik	Ulm
Spain	Hospital Carlos III - Unidad de ELA - Sinesio Delgado, 10	Madrid
United Kingdom	King's MND Care and Research Center - Academic Neurosciences Building PO Box 41 Institute of Psychiatry	London
United Kingdom	Academic Neurology Unit - University of Sheffield - Section of Neuroscience - Division of Genomic Medicine - School of Medicine and Biomedical Sciences	Sheffield

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	Secondary Outcome Measures	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	Every 3 month, from the date of enrollment for a maximum of 15 months.	Yes