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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier:
NCT00694941
First received: June 6, 2008
Last updated: June 12, 2012
Last verified: June 2012
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Ono Pharmaceutical Co. Ltd:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: Oct 2013 ] [ Designated as safety issue: Yes ]
  • Death [ Time Frame: Oct 2013 ] [ Designated as safety issue: Yes ]
  • Tracheotomy or permanent assisted ventilation [ Time Frame: Oct 2013 ] [ Designated as safety issue: Yes ]

Enrollment: 15
Study Start Date: June 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: E
ONO-2506PO in the presence of Riluzole
Drug: ONO-2506PO
1200mg QD / 5 years

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 Patients who were allocated to placebo in ONO-2506POE014 study will be withdrawn from ONO-2506POE015 study, but will continue to be followed up by their site with standard care.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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00694941

Locations
Belgium
Prof. Maloteaux, UCL Saint-Luc
Brussels, Belgium
Prof. Wim Robberecht, UZ Leuven
Leuven, Belgium
France
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
Germany
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
Italy
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
Netherlands
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
Switzerland
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
Investigators
Study Director: Tomohiro Kuwayama Ono Pharma UK
  More Information

No publications provided

Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT00694941     History of Changes
Other Study ID Numbers: ONO-2506POE015
Study First Received: June 6, 2008
Last Updated: June 12, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Switzerland: Swissmedic
Italy: Ethics Committee

Keywords provided by Ono Pharmaceutical Co. Ltd:
ONO-2506PO
Amyotrophic Lateral Sclerosis
ALS

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Sclerosis
Motor Neuron Disease
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
TDP-43 Proteinopathies
Neuromuscular Diseases
Proteostasis Deficiencies
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014