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A Phase II Multi-centre, Extension Study to Investigate the Long Term Safety of ONO-2506PO in Patients Diagnosed With Amyotrophic Lateral Sclerosis (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: NCT00694941
Recruitment Status : Completed
First Posted : June 11, 2008
Last Update Posted : June 13, 2012
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd

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

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis (ALS) Drug: ONO-2506PO Phase 2

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 Patients who were allocated to placebo in ONO-2506POE014 study will be withdrawn from ONO-2506POE015 study, but will continue to be followed up by their site with standard care.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Multi-centre, Extension Study to Investigate the Long Term Safety of ONO-2506PO in Patients Diagnosed With Amyotrophic Lateral Sclerosis (ALS)
Study Start Date : June 2008
Actual Primary Completion Date : December 2008

Arm Intervention/treatment
Experimental: E
ONO-2506PO in the presence of Riluzole
Drug: ONO-2506PO
1200mg QD / 5 years

Primary Outcome Measures :
  1. Adverse Events [ Time Frame: Oct 2013 ]
  2. Death [ Time Frame: Oct 2013 ]
  3. Tracheotomy or permanent assisted ventilation [ Time Frame: Oct 2013 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT00694941

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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 Cedex, France
Prof. Philippe Couratier, Hopital Duruytren
Limoges Cedex, France
Prof. Jan Pouget, Hopital de la Timone
Marseille, France
Prof. William Camu, Hopital de Chauliac
Montpellier cedex 5, France
Prof. Claude Desnuelle, Hopital 1-Archet 1
Nice cedex 3, 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
Hannover, Germany
Prof Gian Domenico Borasio, Interdisziplinares Zentrum fur Palliativmedizin
Munchen, 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
Milano, 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
St. Gallen, Switzerland
United Kingdom
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
Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
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Study Director: Tomohiro Kuwayama Ono Pharma UK

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Responsible Party: Ono Pharmaceutical Co. Ltd Identifier: NCT00694941     History of Changes
Other Study ID Numbers: ONO-2506POE015
First Posted: June 11, 2008    Key Record Dates
Last Update Posted: June 13, 2012
Last Verified: June 2012
Keywords provided by Ono Pharmaceutical Co. Ltd:
Amyotrophic 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