Clinical trial NCT00694941: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Amyotrophic Lateral Sclerosis (ALS)
Keywords: ONO-2506PO
Amyotrophic Lateral Sclerosis
ALS
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2008-06-11
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 Patients who were allocated to placebo in ONO-2506POE014 study will be withdrawn from ONO-2506POE015 study, but will continue to be followed up by their site with standard care.

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

Primary outcomes:
measure: Adverse Events
timeFrame: Oct 2013
measure: Death
timeFrame: Oct 2013
measure: Tracheotomy or permanent assisted ventilation
timeFrame: Oct 2013
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Prof. Maloteaux, UCL Saint-Luc
city: Leuven
country: Belgium
facility: Prof. Wim Robberecht, UZ Leuven
city: Lille Cedex
country: France
facility: Prof. Alain Destee, Hopital Roger Salengro - Clinique Neurologique, Neurologie A
city: Limoges Cedex
country: France
facility: Prof. Philippe Couratier, Hopital Duruytren
city: Marseille
country: France
facility: Prof. Jan Pouget, Hopital de la Timone
city: Montpellier cedex 5
country: France
facility: Prof. William Camu, Hopital de Chauliac
city: Nice cedex 3
country: France
facility: Prof. Claude Desnuelle, Hopital 1-Archet 1
city: Paris
country: France
facility: Prof. Vincent Meininger, Hopital LaPitie Salpetriere
city: Berlin
country: Germany
facility: Dr. Thomas Meyer, Charite Campus Virchow, ALS Ambulanz
city: Bochum
country: Germany
facility: Prof. Torsten Grehl, Neurologische Ambulanz Universitatsklinik Bergmannsheil
city: Erlangen
country: Germany
facility: Professor Dieter Heuss, Poliklinik der Universitat Erlangen-Nurnberg, Neurologische Klinik
city: Halle
country: Germany
facility: Prof. Stephan Zierz, Martin Luther Universitat Halle-Wittenberg, Klinikum der Medizinischen Fakultat, Universitatsklinik und Poliklinik fur Neurologie
city: Hannover
country: Germany
facility: Prof. Reinhard Dengler, Medizinische Hochschule Hannover, Neurologische Klinik
city: Munchen
country: Germany
facility: Prof Gian Domenico Borasio, Interdisziplinares Zentrum fur Palliativmedizin
city: Ulm
country: Germany
facility: Prof. Albert Ludolph, Klinik und Poliklinikfur Neurologie der Universitat Ulm-Univeritatsklinikum Ulm
city: Wiesbarden
country: Germany
facility: Dr. Berthold Schrank, Deutsche Klinik fur Diagnostik, Fachbereich Neurologie
city: Milano
country: Italy
facility: Prof. Vincenzo Silani, Dipartimento di Neurologia e Laboratorio di Neuroscienze - Universita di Milano - IRCCS - Istituto Auxologico Italiano
city: Pavia
country: Italy
facility: Dr. Gabriele Mora, Divisione di Neuroriabilitazione II - Fondazione Salvatore Maugeri - IRCCS
city: Torino
country: Italy
facility: Prof. Adriano Chio, Dipartimento di Neuroscienze - Divisione di Neurologia II - Azienda Ospedaliera S. Giovanni Battista - Molinette
city: Amsterdam
country: Netherlands
facility: Prof Marianne de Visser, Academic Medical Centre (AMC) Amsterdam - Dept of Neurology
city: Utrecht
country: Netherlands
facility: Prof. Leonard H Van Den Berg, University Medical Center Utrecht
city: St. Gallen
country: Switzerland
facility: Dr. Markus Weber, Kantonsspital St. Gallen, Muskelzentrum/ALS Clinic
city: London
country: United Kingdom
facility: Prof. Nigel Leigh, Academic Neuroscience Centre
city: Preston
country: United Kingdom
facility: Prof. Douglas Mitchell, Royal Preston Hospital
city: Sheffield
country: United Kingdom
facility: Dr. Chris McDermott, Royal Hallamshire Hospital
Study officials:
affiliation: Ono Pharma UK
name: Tomohiro Kuwayama
role: STUDY_DIRECTOR
References: