Back to resultsA Phase II Multi-centre, Extension Study to Investigate the Long Term Safety of ONO-2506PO in Patients Diagnosed With Amyotrophic Lateral Sclerosis (ALS)
Primary Purpose
Amyotrophic Lateral Sclerosis (ALS)
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ONO-2506PO
Sponsored by
About this trial
This is an interventional treatment trial for Amyotrophic Lateral Sclerosis (ALS) focused on measuring ONO-2506PO, Amyotrophic Lateral Sclerosis, ALS
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
Sites / Locations
- Prof. Maloteaux, UCL Saint-Luc
- Prof. Wim Robberecht, UZ Leuven
- Prof. Alain Destee, Hopital Roger Salengro - Clinique Neurologique, Neurologie A
- Prof. Philippe Couratier, Hopital Duruytren
- Prof. Jan Pouget, Hopital de la Timone
- Prof. William Camu, Hopital de Chauliac
- Prof. Claude Desnuelle, Hopital 1-Archet 1
- Prof. Vincent Meininger, Hopital LaPitie Salpetriere
- Dr. Thomas Meyer, Charite Campus Virchow, ALS Ambulanz
- Prof. Torsten Grehl, Neurologische Ambulanz Universitatsklinik Bergmannsheil
- Professor Dieter Heuss, Poliklinik der Universitat Erlangen-Nurnberg, Neurologische Klinik
- Prof. Stephan Zierz, Martin Luther Universitat Halle-Wittenberg, Klinikum der Medizinischen Fakultat, Universitatsklinik und Poliklinik fur Neurologie
- Prof. Reinhard Dengler, Medizinische Hochschule Hannover, Neurologische Klinik
- Prof Gian Domenico Borasio, Interdisziplinares Zentrum fur Palliativmedizin
- Prof. Albert Ludolph, Klinik und Poliklinikfur Neurologie der Universitat Ulm-Univeritatsklinikum Ulm
- Dr. Berthold Schrank, Deutsche Klinik fur Diagnostik, Fachbereich Neurologie
- Prof. Vincenzo Silani, Dipartimento di Neurologia e Laboratorio di Neuroscienze - Universita di Milano - IRCCS - Istituto Auxologico Italiano
- Dr. Gabriele Mora, Divisione di Neuroriabilitazione II - Fondazione Salvatore Maugeri - IRCCS
- Prof. Adriano Chio, Dipartimento di Neuroscienze - Divisione di Neurologia II - Azienda Ospedaliera S. Giovanni Battista - Molinette
- Prof Marianne de Visser, Academic Medical Centre (AMC) Amsterdam - Dept of Neurology
- Prof. Leonard H Van Den Berg, University Medical Center Utrecht
- Dr. Markus Weber, Kantonsspital St. Gallen, Muskelzentrum/ALS Clinic
- Prof. Nigel Leigh, Academic Neuroscience Centre
- Prof. Douglas Mitchell, Royal Preston Hospital
- Dr. Chris McDermott, Royal Hallamshire Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
E
Arm Description
ONO-2506PO in the presence of Riluzole
Outcomes
Primary Outcome Measures
Adverse Events
Death
Tracheotomy or permanent assisted ventilation
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00694941
Brief 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)
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 Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ono Pharmaceutical Co. Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis (ALS)
Keywords
ONO-2506PO, Amyotrophic Lateral Sclerosis, ALS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
E
Arm Type
Experimental
Arm Description
ONO-2506PO in the presence of Riluzole
Intervention Type
Drug
Intervention Name(s)
ONO-2506PO
Intervention Description
1200mg QD / 5 years
Primary Outcome Measure Information:
Title
Adverse Events
Time Frame
Oct 2013
Title
Death
Time Frame
Oct 2013
Title
Tracheotomy or permanent assisted ventilation
Time Frame
Oct 2013
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomohiro Kuwayama
Organizational Affiliation
Ono Pharma UK
Official's Role
Study Director
Facility Information:
Facility Name
Prof. Maloteaux, UCL Saint-Luc
City
Brussels
Country
Belgium
Facility Name
Prof. Wim Robberecht, UZ Leuven
City
Leuven
Country
Belgium
Facility Name
Prof. Alain Destee, Hopital Roger Salengro - Clinique Neurologique, Neurologie A
City
Lille Cedex
Country
France
Facility Name
Prof. Philippe Couratier, Hopital Duruytren
City
Limoges Cedex
Country
France
Facility Name
Prof. Jan Pouget, Hopital de la Timone
City
Marseille
Country
France
Facility Name
Prof. William Camu, Hopital de Chauliac
City
Montpellier cedex 5
Country
France
Facility Name
Prof. Claude Desnuelle, Hopital 1-Archet 1
City
Nice cedex 3
Country
France
Facility Name
Prof. Vincent Meininger, Hopital LaPitie Salpetriere
City
Paris
Country
France
Facility Name
Dr. Thomas Meyer, Charite Campus Virchow, ALS Ambulanz
City
Berlin
Country
Germany
Facility Name
Prof. Torsten Grehl, Neurologische Ambulanz Universitatsklinik Bergmannsheil
City
Bochum
Country
Germany
Facility Name
Professor Dieter Heuss, Poliklinik der Universitat Erlangen-Nurnberg, Neurologische Klinik
City
Erlangen
Country
Germany
Facility Name
Prof. Stephan Zierz, Martin Luther Universitat Halle-Wittenberg, Klinikum der Medizinischen Fakultat, Universitatsklinik und Poliklinik fur Neurologie
City
Halle
Country
Germany
Facility Name
Prof. Reinhard Dengler, Medizinische Hochschule Hannover, Neurologische Klinik
City
Hannover
Country
Germany
Facility Name
Prof Gian Domenico Borasio, Interdisziplinares Zentrum fur Palliativmedizin
City
Munchen
Country
Germany
Facility Name
Prof. Albert Ludolph, Klinik und Poliklinikfur Neurologie der Universitat Ulm-Univeritatsklinikum Ulm
City
Ulm
Country
Germany
Facility Name
Dr. Berthold Schrank, Deutsche Klinik fur Diagnostik, Fachbereich Neurologie
City
Wiesbarden
Country
Germany
Facility Name
Prof. Vincenzo Silani, Dipartimento di Neurologia e Laboratorio di Neuroscienze - Universita di Milano - IRCCS - Istituto Auxologico Italiano
City
Milano
Country
Italy
Facility Name
Dr. Gabriele Mora, Divisione di Neuroriabilitazione II - Fondazione Salvatore Maugeri - IRCCS
City
Pavia
Country
Italy
Facility Name
Prof. Adriano Chio, Dipartimento di Neuroscienze - Divisione di Neurologia II - Azienda Ospedaliera S. Giovanni Battista - Molinette
City
Torino
Country
Italy
Facility Name
Prof Marianne de Visser, Academic Medical Centre (AMC) Amsterdam - Dept of Neurology
City
Amsterdam
Country
Netherlands
Facility Name
Prof. Leonard H Van Den Berg, University Medical Center Utrecht
City
Utrecht
Country
Netherlands
Facility Name
Dr. Markus Weber, Kantonsspital St. Gallen, Muskelzentrum/ALS Clinic
City
St. Gallen
Country
Switzerland
Facility Name
Prof. Nigel Leigh, Academic Neuroscience Centre
City
London
Country
United Kingdom
Facility Name
Prof. Douglas Mitchell, Royal Preston Hospital
City
Preston
Country
United Kingdom
Facility Name
Dr. Chris McDermott, Royal Hallamshire Hospital
City
Sheffield
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Phase II Multi-centre, Extension Study to Investigate the Long Term Safety of ONO-2506PO in Patients Diagnosed With Amyotrophic Lateral Sclerosis (ALS)
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