A Phase II Multi-centre, Extension Study to Investigate the Long Term Safety of ONO-2506PO in Patients Diagnosed With Amyotrophic Lateral Sclerosis (ALS)

NCT ID: NCT00694941

Last Updated: 2012-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30

Brief Summary

The objective of this study is to investigate the long term safety of ALS patients taking ONO-2506PO.

Detailed Description

This is an extension study which consists of two phases:

Double-blind phase; Patients will continue to take blinded study medication, as allocated in study ONO-2506POE014 by the central randomization system, in the presence of stable standard Riluzole therapy, until un-blinding of the study results.

Open label phase; Patients who were allocated to ONO-2506PO in the ONO-2506POE014 study will be offered entry into the open label phase of ONO-2506POE015 study and will continue to take 1200 mg of ONO-2506PO for the duration of their participation in the study, in the presence of stable standard Riluzole therapy. Patients who were allocated to placebo in ONO-2506POE014 study will be withdrawn from ONO-2506POE015 study, but will continue to be followed up by their site with standard care.

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

E

ONO-2506PO in the presence of Riluzole

Group Type: EXPERIMENTAL

ONO-2506PO

Intervention Type: DRUG

1200mg QD / 5 years

Interventions

ONO-2506PO

1200mg QD / 5 years

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adult male and female patients with diagnosis of ALS over the age of 18 years.
• Previous randomization and completion of the last visits in ONO-2506POE014 study.
• Patients whom the investigator has no concern and judges tolerable for the continued treatment with ONO-2506PO and Riluzole from a risk and benefit point of view.

Exclusion Criteria

• A clinically relevant medical history or presence of cardiovascular, gastrointestinal, renal, hepatic, endocrine/metabolic, neurologic, lymphatic, haematologic, immunologic, musculoskeletal, connective tissue, dermatologic, genito/urinary, psychiatric diseases or disorders that, in the opinion of the investigator may pose an unwarranted risk to the patient

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ono Pharmaceutical Co. Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tomohiro Kuwayama

Role: STUDY_DIRECTOR

Ono Pharma UK

Locations

Prof. Maloteaux, UCL Saint-Luc

Brussels, , Belgium

Prof. Wim Robberecht, UZ Leuven

Leuven, , Belgium

Prof. Alain Destee, Hopital Roger Salengro - Clinique Neurologique, Neurologie A

Lille, , France

Prof. Philippe Couratier, Hopital Duruytren

Limoges, , France

Prof. Jan Pouget, Hopital de la Timone

Marseille, , France

Prof. William Camu, Hopital de Chauliac

Montpellier, , France

Prof. Claude Desnuelle, Hopital 1-Archet 1

Nice, , France

Prof. Vincent Meininger, Hopital LaPitie Salpetriere

Paris, , France

Dr. Thomas Meyer, Charite Campus Virchow, ALS Ambulanz

Berlin, , Germany

Prof. Torsten Grehl, Neurologische Ambulanz Universitatsklinik Bergmannsheil

Bochum, , Germany

Professor Dieter Heuss, Poliklinik der Universitat Erlangen-Nurnberg, Neurologische Klinik

Erlangen, , Germany

Prof. Stephan Zierz, Martin Luther Universitat Halle-Wittenberg, Klinikum der Medizinischen Fakultat, Universitatsklinik und Poliklinik fur Neurologie

Halle, , Germany

Prof. Reinhard Dengler, Medizinische Hochschule Hannover, Neurologische Klinik

Hanover, , Germany

Prof Gian Domenico Borasio, Interdisziplinares Zentrum fur Palliativmedizin

München, , Germany

Prof. Albert Ludolph, Klinik und Poliklinikfur Neurologie der Universitat Ulm-Univeritatsklinikum Ulm

Ulm, , Germany

Dr. Berthold Schrank, Deutsche Klinik fur Diagnostik, Fachbereich Neurologie

Wiesbarden, , Germany

Prof. Vincenzo Silani, Dipartimento di Neurologia e Laboratorio di Neuroscienze - Universita di Milano - IRCCS - Istituto Auxologico Italiano

Milan, , Italy

Dr. Gabriele Mora, Divisione di Neuroriabilitazione II - Fondazione Salvatore Maugeri - IRCCS

Pavia, , Italy

Prof. Adriano Chio, Dipartimento di Neuroscienze - Divisione di Neurologia II - Azienda Ospedaliera S. Giovanni Battista - Molinette

Torino, , Italy

Prof Marianne de Visser, Academic Medical Centre (AMC) Amsterdam - Dept of Neurology

Amsterdam, , Netherlands

Prof. Leonard H Van Den Berg, University Medical Center Utrecht

Utrecht, , Netherlands

Dr. Markus Weber, Kantonsspital St. Gallen, Muskelzentrum/ALS Clinic

Sankt Gallen, , Switzerland

Prof. Nigel Leigh, Academic Neuroscience Centre

London, , United Kingdom

Prof. Douglas Mitchell, Royal Preston Hospital

Preston, , United Kingdom

Dr. Chris McDermott, Royal Hallamshire Hospital

Sheffield, , United Kingdom

Countries

Belgium; France; Germany; Italy; Netherlands; Switzerland; United Kingdom

Other Identifiers

ONO-2506POE015

Identifier Type: -

Identifier Source: org_study_id